F2016l01253vol01 PDF

Therapeutic Goods (Permissible Ingredients)
Determination No. 2 of 2016

Therapeutic Goods Act 1989
I, Lyndall Soper, a delegate of the Minister for Health and Aged Care for the purposes
of subsection 26BB(1) of the Therapeutic Goods Act 1989 (the Act), HEREBY:
(a) Revoke the Therapeutic Goods (Permissible Ingredients) Determination No. 1
of 2016; and
(b) Make the following determination specifying:
(i)
ingredients for the purposes of paragraph 26BB(1)(a) of the Act; and
(ii)
requirements applying to those ingredients for the purposes of

paragraph 26BB(1)(b) of the Act.
Dated this 27 July 2016
(Signed by)
Lyndall Soper
Delegate of the Minister for Health and Aged Care
Authorised Version F2016L01253 registered 01/08/2016
Name of Determination
This Determination is the Therapeutic Goods (Permissible Ingredients)
Determination No. 2 of 2016.
Commencement
This Determination commences on the day after registration of the
instrument on the Federal Register of Legislation.
Interpretation
In this Determination:
Act means the Therapeutic Goods Act 1989.
Code Tables are tables that can be accessed from the Therapeutic Goods
Administration Business Service website at www.ebs.tga.gov.au under the
heading Public TGA Information.
European Pharmacopeia is as defined under the Act.
Mandatory component is a naturally occurring constituent in a specified
ingredient listed in column 2 of Table 1 of Schedule 1 to this
Determination.
Permissible ingredients and requirements applying to those

ingredients
Permissible ingredients and requirements applying to those ingredients under Table 1

(1) The ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1
(Specified permissible ingredients and requirements applying to these ingredients
when contained in a medicine) to this Determination (Schedule 1) are specified
for the purposes of paragraph 26BB(1)(a) of the Act.
(2) Subject to subsection (3), for the purposes of paragraph 26BB(1)(b) of the Act,
the ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1 are
subject to the following requirements:
(a) they may only be used in a medicine for a purpose or purposes specified in
column 3 of Table 1 in Part 2 of Schedule 1; and
(b) they must comply with the requirements set out in column 4 of Table 1 in
Part 2 of Schedule 1.
(3) The requirements set out in column 4 in relation to a mandatory component of an
ingredient listed in column 2 of Table 1 in Part 2 of Schedule 1 apply to that
specified ingredient.
Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016
Indications and Product Warning Acronyms based on the electronic Code Table
document
(4) The acronyms in column 4 of Table 1 in Part 2 of Schedule 1 in closed brackets
that are associated with warning statements in relation to particular ingredients
specified in column 2 of Table 1 in Part 2 of Schedule 1, are acronyms from the
Code Tables under the headings Indications or Product Warning and are not
required to be included on the label of the medicine.
Note: Examples of these acronyms are:
(CHILD3), (PREGNT), (GLUTEN), (PEANUT) and (ARGIN1).
Additional requirements applying to specified ingredients in Table 1 that are derived

from animal origins
(5) Ingredients specified in column 2 of Table 1 in Part 2 of Schedule 1 that are
derived from animal origins (non-human) must also comply with the following
requirements, for the purposes of paragraph 26BB(1)(b) of the Act:
(a) a certification must be obtained under subsection 26A(4A) of the Act from
the Secretary, prior to an application being made for the listing in the
Australian Register of Therapeutic Goods, under section 26A of the Act, of a
medicine that contains the ingredient, that the Secretary is satisfied of the
safety of the ingredient;
(b) the safety of the ingredient must have been assessed against the principles
and requirements detailed in the European Pharmacopeia general monograph
1483: Products with risk of transmitting agents of animal spongiform
encephalopathies, including General Text 5.2.8: Minimising the risk of
transmitting animal spongiform encephalopathy agents via human and
veterinary medicinal products.
Schedule 1
Schedule 1
Specified permissible ingredients and
requirements applying to these ingredients when contained
in a medicine
(section 4)
Part 1 Interpretation of Table 1

Definitions
At Table 1:
A means an active ingredient.
Act means the Therapeutic Goods Act 1989.
Active ingredient is as defined in the Regulations.
E means an excipient.
Excipient means an ingredient that is not an active ingredient or a homoeopathic
preparation ingredient.
Note: An excipient includes an ingredient that provides flavour, fragrance or colour to the medicine.
H means a homoeopathic preparation ingredient.

Homoeopathic preparation ingredient means an ingredient that is a constituent of a
preparation that is:
(a) formulated for use on the principle that is capable of producing in a
healthy person symptoms similar to those which it is administered to
alleviate; and
(b) prepared according to the practices of homoeopathic pharmacy using the
methods of:
(i) serial dilution and succussion of a mother tincture in water,
ethanol, aqueous ethanol or glycerol; or
(ii) serial trituration in lactose.
Mother tincture is as defined in the Regulations.
Regulations means the Therapeutic Goods Regulations 1990.
Schedule 1
Part 2 -Table 1
Column 1
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine
Specific requirement(s) applying to

the ingredient in Column 2
(1,7,7TRIMETHYLBICYCL
O(2.2.1)HEPT-2-YL)CYCLOHEXANOL
Permitted for use only in combination

with other permitted ingredients as a
fragrance.
(1R,2S,5R)-N-(4METHOXYPHENYL)5-METHYL-2-(1METHYLETHYL)
CYCLOHEXANECAR
BOXAMIDE
(E)-2-(3,5DIMETHYLHEX-3EN-2-YLOXY)-2METHYLPROPYL
CYCLOPROPANECA
RBOXYLATE
(E)-3METHYLCYCLOPEN
TADEC-5-EN-1-ONE
If used in a fragrance the total

fragrance concentration in a medicine
must be no more than 1%.
flavour.
If used in a flavour the total flavour
concentration in the medicine must be
no more than 5%.
fragrance.
fragrance.
(E, E)-2,6NONADIENAL

flavour or a fragrance.
Schedule 1
concentration in a medicine must be

no more than 5%.
must be no more 1%.
6
(S)- LACTIC ACID
A,E,H
(S)-SADENOSYLMETHIO
NINE DISULFATE
DITOSYLATE
DIHYDRATE
(S)-S-Adenosylmethionine is a
mandatory component of (S)-SAdenosylmethionine disulfate
ditosylate dihydrate.
(S)-S-Adenosylmethionine in the form
of sulfate tosylate or mixed
sulfate/tosylate salts requires the
following warning statement on the
medicine label:
- (SAME) 'Individuals who are using
prescription anti-depressants or suffer
from bipolar depression should not use
this product unless under the
supervision of a healthcare practitioner
(or words to that effect)'
(S)-SADENOSYLMETHIO
NINE DISULFATE
TOSYLATE
mandatory component of (S)-SAdenosylmethionine disulfate tosilate.
medicine label:
(S)-SADENOSYLMETHIO
mandatory component of (S)-S-
Schedule 1
NINE DISULFATE
TRITOSYLATE
DIHYDRATE
Adenosylmethionine disulfate
tritosylate dihydrate.
medicine label:
10
(S)-SADENOSYLMETHIO
NINE HEXASULFATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine hexasulfate
dihydrate.
medicine label:
11
(S)-SADENOSYLMETHIO
NINE
HEXATOSYLATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine hexatosylate
dihydrate and must be declared in the
application.
medicine label:
Schedule 1

12
(S)-SADENOSYLMETHIO
NINE
PENTASULFATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine pentasulfate
dihydrate.
medicine label:
-(SAME) 'Individuals who are using
13
(S)-SADENOSYLMETHIO
NINE
PENTATOSYLATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine pentatosylate
dihydrate.
medicine label:
14
(S)-SADENOSYLMETHIO
NINE
mandatory component of (S)-SAdenosylmethionine tetrasulfate
Schedule 1
TETRASULFATE
DIHYDRATE
dihydrate.
medicine label:
15
(S)-SADENOSYLMETHIO
NINE
TETRATOSYLATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine tetratosylate
dihydrate.
medicine label:
16
(S)-SADENOSYLMETHIO
NINE TRISULFATE
DITOSYLATE
DIHYDRATE
mandatory component of (S)-SAdenosylmethionine trisulfate
ditosylate dihydrate.
medicine label:
Schedule 1

17
(Z)-HEX-3-ENYL 2ETHYLBUTYRATE

flavour.
no more than 5%.
18
(Z, Z)-3,6NONADIEN-1-OL

no more than 5%.
must be no more 1%.
19
()-NARINGENIN

flavour.
no more than 5%.
20
1-(2,2,6TRIMETHYLCYCLO
HEXYL)-3-HEXANOL

fragrance.
21
1-(2,6,6-TRIMETHYL2-CYCLOHEXEN-1YL)-1-PENTEN-3ONE

fragrance.
10
Schedule 1

22
23
1-(3,3DIMETHYLCYCLOH
EXYL)ETHYL
FORMATE
1-(4ISOPROPYLCYCLOH
EXYL)ETHANOL

fragrance.
fragrance.
24
1-(5,5-DIMETHYL-1CYCLOHEXEN-1YL)-4-PENTEN-1ONE

fragrance.
25
1-DODECANOL
Only for use in topical medicines for

dermal application.
26
1-HEPTANOL



no more than 5%.
must be no more 1%.
27
1-HEXEN-3-OL

fragrance.
11
Schedule 1

28
1-METHOXY-4PROPENYLBENZENE

flavour.
no more than 5%.
29
30
1-METHYL-2-[(1,2,2TRIMETHYLBICYCL
O[3.1.0]HEX-3YL)METHYL]CYCLOPROPANEME
THANOL
1-METHYL-3-(2METHYLPROPYL)CYCLOHEXANOL

fragrance.
fragrance.
31
32
1-METHYL-4-(4METHYL-3PENTENYL)-3CYCLOHEXENE-1CARBOXALDEHYDE
1-OCTEN-3-ONE

fragrance.
flavour.
no more than 5%.
33
1-P-MENTHENE-8THIOL

flavour.
12
Schedule 1

no more than 5%.
34
1-PENTEN-3-OL

flavour.
no more than 5%.
35
1,1,1TRICHLOROETHANE
The concentration in the medicine

36
1,2-HEXANEDIOL

dermal application and not to be
included in topical products intended
for use in the eye.
37
1,3-BUTYLENE
GLYCOL
38
1,3-NONANEDIOL
ACETATE, MIXED
ESTERS

no more than 5%.
must be no more 1%.
39
1,3-NONANEDIOL,
DIACETATE

fragrance.
40
1,3,4,6,7,8AHEXAHYDRO-1,1,5,5-

13
Schedule 1
TETRAMETHYL-2H2,4AMETHANONAPHTHA
LEN-8(5H)-ONE
41
1,3,5UNDECATRIENE
fragrance.
E

no more than 5%.
must be no more 1%.
42
1,4-CINEOLE

no more than 5%.
must be no more 1%
43
1,4DIOXACYCLOHEXA
DECANE-5,16-DIONE

fragrance.
44
1,5,9-TRIMETHYL-13OXABICYCLO[10.1.0]
TRIDECA-4,8-DIENE

fragrance.
14
Schedule 1
45
46
1,7,7TRIMETHYLBICYCL
O[4.4.0]DECAN-3-YL
ACETATE
10-UNDECEN-1-OL

fragrance.
flavour.
no more than 5%.
47
10-UNDECENAL

no more than 5%.
must be no more 1%.
48
49
50
16-HYDROXY-12OXAHEXADECANOI
C ACID, OMEGALACTONE
2-(1,1DIMETHYLETHYL)1,4-DIMETHOXYBENZENE
2-(2-(4-METHYL-3CYCLOHEXEN-1YL)PROPYL

fragrance.
fragrance.
15
Schedule 1
CYCLOPENTANONE
fragrance.
51
2-ACETYLFURAN

flavour.
no more than 5%.
52
2-ACETYLPYRAZINE

flavour.
no more than 5%.
53
2-ACETYLPYRIDINE

no more than 5%.
must be no more 1%.
54
2-AMINO-2METHYL-1PROPANOL

dermal application.
55
2-BENZYL-4,4,6TRIMETHYL-1,3DIOXANE

fragrance.
16
Schedule 1
56
2-BUTEN-1-OL

fragrance.
57
58
2CYCLOHEXYLIDENE
-2-O-TOLYLACETONITRILE
2-DECENAL

fragrance.
flavour.
no more than 5%.
59
2-DODECANOL

no more than 5%.
must be no more 1%.
60
2-DODECENAL

no more than 5%.
17
Schedule 1
must be no more 1%.

61
2-ETHOXY-4(METHOXYMETHYL)
-PHENOL

fragrance.
62
2-ETHOXYETHANOL
The residual solvent limit for 2Ethoxyethanol is 1.6 mg per maximum

recommended daily dose.
must be no more than 0.016%.
63
2-ETHYL-1HEXANOL

flavour.
no more than 5%.
64
2-ETHYL-3METHYLPYRAZINE

flavour.
no more than 5%.
65
2-ETHYL-3,5DIMETHYLPYRAZIN
E

no more than 5%.
must be no more 1%.
66
2-ETHYL-3,6DIMETHYLPYRAZIN

18
Schedule 1
no more than 5%.
must be no more 1%.
67
2-ETHYL-4-(2,2,3TRIMETHYL-3CYCLOPENTEN-1YL)-2-BUTEN-1-OL

no more than 5%.
must be no more 1%.
68
69
2-ETHYL-4HYDROXY-5METHYL-3(2H)FURANONE
2-ETHYL-4METHYLTHIAZOLE

flavour.
no more than 5%.
flavour.
no more than 5%.
70
2-ETHYLALPHA,ALPHADIMETHYLBENZENEPROPANAL

no more than 5%.
19
Schedule 1

must be no more 1%.
71
2-ETHYL METHYL
BUTYRATE

flavour.
no more than 5%.
72
2-ETHYLBUTYRIC
ACID

flavour.
no more than 5%.
73
2-HEPTANOL

flavour.
no more than 5%.
74
2-HEPTANONE

no more than 5%.
must be no more 1%.
75
2-HEPTYL
CYCLOPENTANONE

fragrance.
20
Schedule 1
76
2-HEXENYL
ACETATE

no more than 5%.
must be no more 1%.
77
2-ISOBUTYL-3METHOXYPYRAZIN
E

fragrance.
78
2-ISOBUTYL-4METHYLTETRAHYD
RO-2H-PYRAN-4-OL

fragrance.
79
2ISOPROPOXYETHYL
SALICYLATE

fragrance.
80
2-ISOPROPYL-4METHYLTHIAZOLE

no more than 5%.
21
Schedule 1
must be no more 1%.

81
2MERCAPTOPROPION
IC ACID

flavour.
no more than 5%.
82
2-METHOXY-3SECBUTYLPYRAZIN
E

fragrance.
83
2-METHOXY-4VINYLPHENOL

flavour.
no more than 5%.
84
2-METHYL-2PENTENOIC ACID

flavour.
no more than 5%.
85
86
2-METHYL-2-VINYL5ISOPROPENYLTETR
AHYDROFURAN
2-METHYL-3-(3,4METHYLENEDIOXY
PHENYL)PROPANAL

flavour.
no more than 5%.
22
Schedule 1

no more than 5%.
must be no more 1%.
87
2-METHYL-3-(4METHOXYPHENYL)P
ROPANAL

fragrance.
88
2-METHYL-3-BUTEN2-OL

flavour.
no more than 5%.
89
2-METHYL-3FURANTHIOL

flavour.
no more than 5%.
90
2-METHYL-3-[4-(2METHYLPROPYL)PH
ENYL]PROPANAL

fragrance.
91
2-METHYL-4-(2,2,3TRIMETHYL-3CYCLOPENTEN-1YL)BUTANOL

fragrance.
23
Schedule 1
92
93
2-METHYL-4-(2,6,6TRIMETHYL-1CYCLOHEXEN-1YL)-2-BUTENAL
2-METHYL-4PROPYL-1,3OXTHIANE

fragrance.
flavour.
no more than 5%.
94
2-METHYL-5(METHYLTHIO)FUR
AN

flavour.
no more than 5%.
95
2-METHYL-5PHENYLPENTANOL

flavour.
no more than 5%.
96
2-METHYL BUTYRIC
ACID

no more than 5%.
must be no more 1%.
97
2-METHYL
HEPTANOIC ACID

24
Schedule 1
flavour.
no more than 5%.
98
2-METHYLBUTYL
ACETATE

flavour.
no more than 5%.
99
2-METHYLBUTYL
ISOVALERATE

flavour.
no more than 5%.
100
2-METHYLBUTYL
PHENYLETHYL
ETHER

fragrance.
101
2-METHYLBUTYL
SALICYLATE

fragrance.
102
2METHYLHEXANOIC
ACID

flavour.
no more than 5%.
25
Schedule 1
103
2METHYLPYRAZINE

no more than 5%.
must be no more 1%.
104
2METHYLTETRAHYD
ROFURAN-3-ONE

flavour.
no more than 5%.
105
2METHYLUNDECANA
L

no more than 5%.
must be no more 1%.
106
2-METHYLVALERIC
ACID

flavour.
no more than 5%.
107
2-NONENAL

26
Schedule 1
no more than 5%.

must be no more 1%.
108
2-NONENENITRILE

fragrance.
109
2-OXOBUTYRIC
ACID

flavour.
no more than 5%.
110
2-PENTANOL

flavour.
no more than 5%.
111
2-PENTANONE

flavour.
no more than 5%.
112
2-PENTENAL

flavour.
no more than 5%.
27
Schedule 1
113
2-PENTYL FURAN

no more than 5%.
must be no more 1%.
114
2PHENYLPROPIONAL
DEHYDE

no more than 5%.
must be no more 1%.
115
2PHENYLPROPIONAL
DEHYDE DIMETHYL
ACETAL

no more than 5%.
must be no more 1%.
116
2-PROPENOIC ACID

fragrance.
117
2-SEC-BUTYL
CYCLOHEXANONE

28
Schedule 1
fragrance.
118
2-TERTBUTYLCYCLOHEXA
NOL

fragrance.
119
2-TERTBUTYLCYCLOHEXY
LOXY-2-BUTANOL

fragrance.
120
2-TRANS-6-CISNONADIENAL

no more than 5%.
must be no more 1%.
121
2-TRIDECANONE

no more than 5%.
29
Schedule 1
122
2-TRIDECENAL

no more than 5%.
must be no more 1%.
123
2TRIDECENENITRILE

fragrance.
124
2-UNDECENAL

flavour.
no more than 5%.
125
126
127
2-[(3,7-DIMETHYL-6OCTEN-1YLIDENE)AMINO]BE
NZOIC ACID,
METHYL ESTER
2-[1-(3,3DIMETHYLCYCLOH
EXYL)ETHOXY]-2METHYLPROPYL]
CYCLOPROPANECA
RBOXYLATE
2-[1-(3,3DIMETHYLCYCLOH
EXYL)ETHOXY]-2-

fragrance.
fragrance.
30
Schedule 1
OXOETHYL
PROPANOATE
128
2,2-DIMETHYL-3PHENYLPROPANOLL
fragrance.
E

fragrance.
129
130
2,2-DIMETHYL-5-(1METHYLPROPEN-1YL)
TETRAHYDROFURA
N
2,2-DIMETHYL-PETHYLPHENYLPROPANENITRILE

flavour.
no more than 5%.
fragrance.
131
132
2,2,3TRIMETHYLCYCLOP
ENT-3-ENE-1-ETHYL
ACETATE
2,2,5-TRIMETHYL-5PENTYLCYCLOPENT
ANONE

fragrance.
fragrance.
31
Schedule 1
133
2,3DIETHYLPYRAZINE

flavour.
If used as a flavour the total flavour
no more than 5%.
134
135
2,3-DIHYDRO-2,5DIMETHYL-1HINDENE-2METHANOL
2,3-HEXADIONE

fragrance.
flavour.
no more than 5%.
136
2,3-HEXANEDIONE

flavour.
no more than 5%.
137
2,3-PENTANEDIONE

no more than 5%.
must be no more 1%.
138
2,3,4-TRIMETHYL-3PENTANOL

32
Schedule 1
flavour.
no more than 5%.
139
2,3,5TRIMETHYLPYRAZI
NE

flavour.
no more than 5%.
140
2,3,5,6TETRAMETHYLPYR
AZINE

flavour.
no more than 5%.
141
2,4-DECADIENAL

flavour.
no more than 5%.
142
2,4-DIMETHYL-3CYCLOHEXENE
CARBOXALDEHYDE

fragrance.
143
2,4-DIMETHYL-4PHENYL
TETRAHYDROFURA
N

fragrance.
33
Schedule 1
144
145
2,4-DIMETHYL4,4A,5,9BTETRAHYDROINDE
NO[1,2-D]-1,3DIOXIN
2,4-DIMETHYL
BUTADIENEACROLE
IN

fragrance.
fragrance.
146
2,4-DIMETHYL
THIAZOLE

flavour.
no more than 5%.
147
2,4-HEXADIENOL

flavour.
no more than 5%.
148
2,4,5TRIMETHYLTHIAZO
LE

flavour.
no more than 5%.
149
2,4,6-TRIMETHYL-4PHENYL-1,3DIOXANE

fragrance.
34
Schedule 1

150
2,5DIETHYLTETRAHYD
ROFURAN

flavour.
no more than 5%.
151
2,5-DIMETHYL-2OCTEN-6-ONE

fragrance.
152
2,5-DIMETHYL-4HYDROXY-3(2H)FURANONE

flavour or fragrance.
no more than 5%.
153
2,5-DIMETHYL-4METHOXY-3(2H)FURANONE

flavour.
no more than 5%.
154
2,5DIMETHYLPYRAZIN
E

no more than 5%.
must be no more 1%.
If used in a printing ink the total
35
Schedule 1
printing ink concentration in a

medicine must be no more than 0.1%
155
2,6DIMETHOXYPHENO
L

flavour.
no more than 5%.
156
2,6-DIMETHYL-2HEPTENAL-(7)

no more than 5%.
must be no more 1%.
157
2,6-DIMETHYL-3,5OCTADIEN-2-OL

fragrance.
158
2,6-DIMETHYL-4HEPTYL ACETATE

fragrance.
159
2,6-DIMETHYL
HEPTAN-2-OL

fragrance.
36
Schedule 1
160
2,6DIMETHYLPYRAZIN
E

no more than 5%.
must be no more 1%.
161
2,6-NONADIEN-1-OL

no more than 5%.
must be no more 1%.
162
163
2,6-OCTADIENOIC
ACID, 3,7DIMETHYL-,
METHYL ESTER,
(2E)-
2,6,6,TRIMETHYL-2CYCLOHEXENE-1,4DIONE

fragrance.
no more than 5%.
must be no more 1%.
164
2,6,9,10TETRAMETHYL-1OXASPIRO(4.5)DECA

37
Schedule 1
-3,6-DIENE
fragrance.
165
3-(3ISOPROPYLPHENYL)
BUTANAL

fragrance.
166
167
168
3-(4ETHYLPHENYL)-2,2DIMETHYLPROPAN
AL
3-(4HYDROXYPHENYL)1-(2,4,6TRIHYDROXYPHEN
YL)-1-PROPANONE
3-(4-TERTBUTYLPHENYL)PROPANAL

fragrance.
flavour.
no more than 5%.
fragrance.
169
3-(ISO-CAMPHYL-5)CYCLOHEXANOL

fragrance.
38
Schedule 1
170
3-(METHYLTHIO)-1HEXYL ACETATE

flavour.
no more than 5%.
171
3-CARENE

no more than 5%.
must be no more 1%.
172
3-DODECENAL

fragrance.
173
3-ETHYLPYRIDINE

flavour.
no more than 5%.
174
3-HEPTYLDIHYDRO5-METHYL-2(3H)FURANONE

flavour.
no more than 5%.
175
3-HEXANONE

39
Schedule 1
flavour.
no more than 5%.
176
3-HEXEN-1-OL

no more than 5%.
must be no more 1%.
177
3-ISO-CAMPHYL-5CYCLOHEXAN-1-OL

fragrance.
178
3-METHYL-2(PENTYLOXY)CYCL
OPENT-2-EN-1-ONE

fragrance.
179
180
3-METHYL-5-(2,2,3TRIMETHYL-3CYCLOPENTEN-1YL)-4-PENTEN-2-OL
3-METHYL-5PHENYL PENT-2ENENITRILE

fragrance.
fragrance.
40
Schedule 1

181
3-METHYL-5PHENYLPENTANAL

fragrance.
182
3-METHYL-5PHENYLPENTANENI
TRILE

fragrance.
183
3-METHYL-5PHENYLPENTANOL

fragrance.
184
185
3-METHYL-5PROPYL-2CYCLOHEXEN-1ONE
3-METHYL
THIOPROPIONALDE
HYDE ETHANOL

fragrance.
flavour.
no more than 5%.
186
3METHYLCYCLOPEN
TADECANONE

fragrance.
41
Schedule 1

187
3METHYLCYCLOPEN
TADECENONE

fragrance.
188
3METHYLTHIOHEXA
NOL

flavour.
no more than 5%.
189
3-OCTANOL

no more than 5%.
must be no more 1%.
190
191
3PENTYLTETRAHYD
RO-2H-PYRAN-4-OL
ACETATE
3PHENYLPROPIONAL
DEHYDE

fragrance.
42
Schedule 1
no more than 5%.

must be no more 1%.
192
3-PHENYLPROPYL
ACETATE

no more than 5%.
must be no more 1%.
193
3-PHENYLPROPYL
PROPIONATE

flavour.
no more than 5%.
194
3-PROPYLIDENE
PHTHALIDE

no more than 5%.
must be no more 1%.
195
3-TRANSISOCAMPHYLCYCL
OHEXANOL

fragrance.
43
Schedule 1
196
197
3,3-DIMETHYL-5(2,2,3-TRIMETHYL-3CYCLOPENTEN-1YL)-4-PENTEN-2-OL
3,3DIMETHYLACRYLIC
ACID

fragrance.
flavour.
no more than 5%.
198
3,4-DIMETHYL-1,2CYCLOPENTADIONE

flavour.
no more than 5%.
199
200
3,4,4A,5,8,8AHEXAHYDRO-3',7DIMETHYLSPIRO1,4METHANONAPHALE
NE-2(1H),2'-OXIRANE
3,5DIMETHOXYTOLUE
NE

fragrance.
fragrance.
201
3,5-DIMETHYL-3CYCLOHEXENE-1CARBOXALDEHYDE

fragrance.
44
Schedule 1

202
3,5,5-TRIMETHYL
HEXANAL

fragrance.
203
3,5,5TRIMETHYLHEXYL
ACETATE

fragrance.
204
205
3,5,6,6TETRAMETHYL-4METHYLENEHEPTA
N-2-ONE
3,6-DIMETHYL-3CYCLOHEXENE-1CARBOXALDEHYDE

fragrance.
fragrance.
206
3,7-DIMETHYL-1OCTANOL

no more than 5%.
must be no more 1%.
45
Schedule 1
207
3,7-DIMETHYL-2,6NONADIENENITRILE

fragrance.
208
3,7-DIMETHYL-7METHOXYOCTAN-2OL

fragrance.
209
3,7-DIMETHYL
OCTANAL

fragrance.
210
211
212
3A,6,6,9ATETRAMETHYLDOD
ECAHYDRONAPHTH
O[2,1-B] FURAN
4-(4-HYDROXY-4METHYLPENTYL)-3CYCLOHEXENE
CARBOXALDEHYDE
4-(4-METHYL-3PENTEN-1-YL)-3CYCLOHEXENE-1CARBOXALDEHYDE

fragrance.
fragrance.
46
Schedule 1
no more than 5%.

must be no more 1%.
213
214
4-(5,5,6TRIMETHYLBICYCL
O(2.2.1)HEPT-2-YL)CYCLOHEXANOL
4-(METHYLTHIO)-4METHYL-2PENTANONE

fragrance.
flavour.
no more than 5%.
215
4-(PARAHYDROXYPHENYL)2-BUTANONE

no more than 5%.
must be no more 1%.
216
4-(PARAMETHOXYPHENYL)2-BUTANONE

no more than 5%.
must be no more 1%.
47
Schedule 1
217
218
4-ACETYL-6TERTIARY-BUTYL1,1DIMETHYLINDAN
4-ETHYL GUAIACOL

fragrance.
no more than 5%.
must be no more 1%.
219
4-HEPTANONE

flavour.
no more than 5%.
220
4HYDROXYBENZALD
EHYDE

fragrance.
221
4-HYDROXYBENZYL
ALCOHOL

flavour.
no more than 5%.
222
4-METHOXY-2METHYL-2-

48
Schedule 1
BUTANETHIOL
flavour.
no more than 5%.
223
4-METHYL-3-DECEN5-OL

fragrance.
224
4-METHYL-4MERCAPTOPENTAN2-ONE

flavour.
no more than 5%.
225
4-METHYL-4PHENYL-2-PENTYL
ACETATE

fragrance.
226
4-METHYL-5THIAZOLETHANOL

no more than 5%.
must be no more 1%.
227
4METHYLBENZYLIDE
NE CAMPHOR
Only for use as an active ingredient in

sunscreens.
49
Schedule 1
included in medicines intended for use

in the eye.
228
4METHYLPENTANOIC
ACID

flavour.
no more than 5%.
229
4-METHYLPHENYL
OCTANOATE

no more than 5%.
must be no more 1%.
230
4-PARA
METHOXYPHENYL3-BUTANONE

flavour.
no more than 5%.
231
4-PENTENOIC ACID

flavour.
no more than 5%.
232
4-TERT-BUTYL-2,6DIMETHYL
ACETOPHENONE

fragrance.
50
Schedule 1

233
4-TERTBUTYLCYCLOHEXA
NOL

included in medicines for use in the
eye or on damaged skin.
234
4-TERTPENTYLCYCLOHEX
ANONE

fragrance.
235
236
237
238
4,4A,5,9BTETRAHYDRO-2,4DIMETHYLINDENO(1,2-D)-1,3DIOXIN
4,4A,5,9BTETRAHYDROINDE
NO(1,2-D)-1,3DIOXIN
4,7-METHANO3A,4,5,6,7,7AHEXAHYDRO-5 (OR
6) -INDENYL
ACETATE
4,8-DIMETHYL-3,7NONADIEN-2-OL

fragrance.
fragrance.
fragrance.
fragrance.
51
Schedule 1

239
240
5-(2,2,3-TRIMETHYL3-CYCLOPENTEN-1YL)-3METHYLPENTAN-2OL
5-ACETYL-1,1,2,3,3,6HEXAMETHYL
INDAN

fragrance.
no more than 5%.
must be no more 1%.
241
5CYCLOHEXADECEN1-ONE

fragrance.
242
243
5-ETHYL-3HYDOXY-4METHYL-2(5H)FURANONE
5-ETHYL-4HYDROXY-2METHYL-3(2H)FURANONE

flavour.
no more than 5%.
flavour.
52
Schedule 1
no more than 5%.

244
245
5-HYDROXY-4METHYLHEXANOIC
ACID DELTALACTONE
5METHOXYPSORALE
N

flavour.
no more than 5%.
fragrance.
246
5-METHYL-2THIOPHENE
CARBOXALDEHYDE

flavour.
no more than 5%.
247
248
5-METHYL-3BUTYLTETRAHYDR
OPYRAN-4-YL
ACETATE
5-METHYL-3HEPTANONE OXIME

fragrance.
fragrance.
249
5-METHYL 2PHENYL HEXEN-2AL

flavour.
53
Schedule 1

no more than 5%.
250
5-PENTYL-2(5H)FURANONE

flavour.
no more than 5%.
251
5,6,7,8TETRAHYDROQUIN
OXALINE

flavour.
no more than 5%.
252
5,7-DIHYDRO-2METHYLTHIENO
(3,4D) PYRIMIDINE

flavour.
no more than 5%.
253
6-METHOXY-2,6DIMETHYLHEPTAN1-AL

fragrance.
254
6-METHYL-2-BUTEN3-OL-2
255
6-METHYL
COUMARIN

flavour.
no more than 5%.
54
Schedule 1
256
6,6-DIMETHOXY2,5,5-TRIMETHYL-2HEXENE

fragrance.
257
6,6-DIMETHYL-2NORPINENEPROPIO
NALDEHYDE

fragrance.
258
259
260
6,7-DIHYDRO1,1,2,3,3PENTAMETHYL4(5H)-INDANONE
7-ACETYL-1,1,3,4,4,6HEXAMETHYL
TETRAHYDRONAPH
THALENE
7-METHYL-2H-1,5BENZODIOXEPIN3(4H)-ONE

fragrance.
fragrance.
no more than 5%.
must be no more 1%.
261
7-OCTENE-1,6-DIOL,
3,7-DIMETHYL-

55
Schedule 1
fragrance.
262
7-PROPYL-2H-1,5BENZODIOXEPIN3(4H)-ONE

fragrance.
263
8-METHYL-1OXASPIRO(4,5)DECA
N-2-ONE

fragrance.
264
8-OCIMENYL
ACETATE

flavour.
no more than 5%.
265
8,13:13,20-DIEPOXY14,15BISNORLABDANE

fragrance.
266
9-DECEN-1-OL

fragrance.
56
Schedule 1
267
ABELMOSCHUS
MOSCHATUS
A,H
268
ABELMOSCHUS
MOSCHATUS SUBSP.
MOSCHATUS
A,H
269
ABIES BALSAMEA
A,H
270
ABIES NIGRA
A,H
271
ABIES PECTINATA
A,H
272
ABIES SIBIRICA
A,H
273
ABRUS
CANTONIENSIS
A,H
274
ABSIDIA RAMOSA
A,H
275
ABUTILON
THEOPHRASTI
A,H
276
ACACIA
A,E,H
277
ACACIA
BAILEYANA
A,H
278
ACACIA CATECHU
A,H
279
ACACIA DEALBATA
A,H
280
ACACIA
DECURRENS
If the herbal substance is derived from

the seed, the maximum recommended
daily dose of Abrus cantoniensis must
be no more than 1mg of the dry seed.

flavour.
no more than 5%.
281
ACACIA
FARNESIANA

flavour.
57
Schedule 1
no more than 5%.

282
ACACIA
LONGIFOLIA
A,E,H
283
ACACIA NILOTICA
A,E,H
284
ACACIA SENEGAL
A,E,H
285
ACALYPHA INDICA
A,H
286
ACANTHUS MOLLIS
A,H
287
ACER CAMPESTRE
A,H
288
ACER NEGUNDO
A,H
289
ACER
SACCHARINUM
A,H
290
ACER SACCHARUM
A,E,H
291
ACEROLA
292
ACESULFAME
POTASSIUM
293
ACETAL

no more than 5%.
must be no more 1%.
294
ACETALDEHYDE

no more than 5%.
58
Schedule 1

must be no more 1%.
295
ACETALDEHYDE
ETHYL LINALYL
ACETAL

fragrance.
296
297
ACETALDEHYDE
ETHYL
PHENYLETHYL
ACETAL
ACETALDEHYDE
PHENYLETHYL
PROPYL ACETAL

fragrance.
fragrance.
298
ACETANISOLE

dermal application.
299
ACETIC ACID
E,H

300
ACETIC ACID GLACIAL
E,H

301
ACETOIN

no more than 5%.
59
Schedule 1
must be no more 1%.

302
ACETOMENAPHTHO
NE
A,E
When used as an active ingredient and

the route of administration is oral or
sublingual, the medicine requires the
medicine label:
- (VIT) 'Vitamins can only be of
assistance if the dietary vitamin intake
is inadequate.' or 'Vitamin
supplements should not replace a
balanced diet.'
303
ACETONE
The residual solvent limit for Acetone

is 50 mg per maximum recommended
daily dose.
304
ACETOPHENONE

no more than 5%.
must be no more 1%.
305
ACETOVANILLONE

dermal application.
fragrance.
If used as a fragrance the total
306
ACETYL

60
Schedule 1
flavour.
no more than 5%.
307
ACETYL DIPEPTIDE1 CETYL ESTER

in the eye.
308
ACETYL
GLUCOSAMINE

in the eye.
If the ingredient is sourced from
seafood, then the medicine requires the
medicine label:
- (SFOOD) 'Derived from seafood'
309
ACETYL
HEXAMETHYL
TETRALIN

fragrance.
310
ACETYL
LEVOCARNITINE
HYDROCHLORIDE
A,E
311
ACETYL
TRIFLUOROMETHYL
PHENYL
VALYLGLYCINE

in the eye.
61
Schedule 1

312
ACETYLATED
LANOLIN

dermal application.
313
ACETYLATED
LANOLIN ALCOHOL

dermal application.
314
ACETYLATED
MONOGLYCERIDES
315
ACETYLATED
VETIVER OIL

fragrance.
316
ACETYLCYSTEINE

dermal application.
317
ACHILLEA ERBAROTTA SUBSP.

MOSCHATA
A,H
318
ACHILLEA
MILLEFOLIUM
A,E,H
319
ACHILLEA
PTARMICA
A,H
320
ACHYRANTHES
ASPERA
A,H
321
ACHYRANTHES
BIDENTATA
A,H
322
ACHYRANTHES
FAURIEI
A,H
323
ACID-ISOMERISED
LINALOOL
62
Schedule 1
324
ACID GREEN 25
Permitted for use as a colour for

topical use.
325
ACID RED 33

topical use.
326
ACID RED 87
E,H
Only for use as an active

homoeopathic ingredient or for
excipient use as a colour in topical
medicines.
327
ACONITUM
CARMICHAELII
A,H
Total alkaloids (of Aconitum spp.) is a

mandatory component of Aconitum
carmichaelii.
The maximum amount of total
alkaloids (of Aconitum spp.) must be
no more than 0.02 milligrams per
pack.
328
ACONITUM FEROX
A,H

ferox.
pack.
329
ACONITUM
KUSNEZOFFI
A,H

kusnezoffii.
pack.
330
ACONITUM
NAPELLUS
A,H

napellus.
pack.
63
Schedule 1
331
ACRYLAMIDE/SODI
UM
ACRYLOYLDIMETH
YLTAURATE
COPOLYMER

in the eye.
332
ACRYLAMIDES
COPOLYMER

dermal application.
333
ACRYLATES
COPOLYMER

dermal application.
334
ACRYLATES/ACRYL
AMIDE COPOLYMER

dermal application.
335
ACRYLATES/C10-30
ALKYL ACRYLATE
CROSSPOLYMER

dermal application.
336
ACRYLATES/C12-22
ALKYL
METHACRYLATE
COPOLYMER

in the eye.


337
ACRYLATES/DIMET
HICONE
COPOLYMER

in the eye.
338
ACRYLATES/OCTYL
ACRYLAMIDE
COPOLYMER

dermal application.
339
ACRYLATES/STEAR
ETH-20
METHACRYLATE
COPOLYMER

in the eye.
64
Schedule 1

340
ACRYLATES/VA
COPOLYMER

dermal application.
341
ACRYLIC ACID/VP
CROSSPOLYMER

in the eye.
342
ACTAEA
CIMICIFUGA
A,H
343
ACTAEA
HERACLEIFOLIA
A,H
344
ACTAEA
PACHYPODA
A,H
345
ACTAEA RACEMOSA A,H
When used in oral medicines, the

medicine requires the following
warning statement on the medicine
label:
- (BCOHOSH) 'Warning: In very rare
cases - black cohosh has been
associated with liver failure. If you are
experiencing yellowing of the skin or
whites of the eyes - dark urine - nausea
- vomiting - unusual tiredness weakness - stomach or abdominal pain
- and/or loss of appetite - you should
stop using this product and see your
doctor.'
346
ACTAEA SIMPLEX
A,H
347
ACTAEA SPICATA
A,H
348
ACTINIDIA
CHINENSIS
A,H
349
ACTINIDIA
A,H
65
Schedule 1
DELICIOSA
350
ADEMETIONINE
DISULFATE
DITOSYLATE
DIHYDRATE
A,H
mandatory component of
Ademetionine disulfate ditosylate
dihydrate.
Ademetionine in the form of sulfate
tosylate or mixed sulfate/tosylate salts
requires the following warning
statement on the medicine label:
351
ADEMETIONINE
DISULFATE
TOSYLATE
A,H
Ademetionine disulfate ditosylate.
352
ADEMETIONINE
DISULFATE
TRITOSYLATE
DIHYDRATE
A,H
Ademetionine trisulfate ditosylate
dihydrate.
66
Schedule 1

353
ADEMETIONINE
HEXASULFATE
DIHYDRATE
A,H
Ademetionine hexasulfate dihydrate.
354
ADEMETIONINE
HEXATOSYLATE
DIHYDRATE
A,H
Ademetionine hexatosylate dihydrate.
355
ADEMETIONINE
PENTASULFATE
DIHYDRATE
A,H
Ademetionine pentasulfate dihydrate.
67
Schedule 1

356
ADEMETIONINE
PENTATOSYLATE
DIHYDRATE
A,H
Ademetionine pentatosylate dihydrate.
357
ADEMETIONINE
TETRASULFATE
DIHYDRATE
A,H
Ademetionine tetrasulfate ditosylate
dihydrate.
358
ADEMETIONINE
TETRATOSYLATE
DIHYDRATE
A,H
Ademetionine tetratosylate dihydrate.
68
Schedule 1

359
ADEMETIONINE
TRISULFATE
DITOSYLATE
DIHYDRATE
A,H
Ademetionine trisulfate ditosylate
dihydrate.
medicine label:
360
ADENOPHORA
STRICTA
A,H
361
ADENOPHORA
TRIPHYLLA
A,H
362
ADENOSINE

in the eye or on damaged skin.
363
ADENOSINE

69
Schedule 1
PHOSPHATE

in the eye.
364
ADENOSINE
TRIPHOSPHATE

dermal application.
365
ADENOSINE
TRIPHOSPHATE
DISODIUM

dermal application.
366
ADIANTUM
CAPILLUS-VENERIS
A,H
367
ADIPIC ACID
368
ADIPIC
ACID/DIETHYLENE
GLYCOL/GLYCERIN
CROSSPOLYMER

in the eye.
369
ADONIS VERNALIS
A,H
The concentration of equivalent dry

Adonis vernalis in the medicine must
be no more than 10mg/Kg or 10mg/L
or 0.001%.
370
ADRENALINE
(EPINEPHRINE)

homoeopathic ingredient.
371
ADZUKI BEAN
372
AEGOPODIUM
PODAGRARIA
A,H
373
AESCULUS
CHINENSIS
A,H
374
AESCULUS GLABRA
A,H
375
AESCULUS
HIPPOCASTANUM
A,H
70
Schedule 1
376
AESCULUS X
CARNEA
A,H
377
AETHUSA
CYNAPIUM
378
AGAR
A,E
379
AGASTACHE
RUGOSA
A,H
380
AGATHOSMA
BETULINA
A,E,H

Pulegone is a mandatory component of

Agathosma betulina.
The concentration of pulegone in the
medicine must be no more than 4%.
381
AGAVE AMERICANA
A,E,H
382
AGRIMONIA
EUPATORIA
A,E,H
383
AGRIMONIA REPENS
A,H
384
AGROSTIS TENUIS
A,H
385
AILANTHUS
ALTISSIMA
A,H
386
AJUGA
CHAMAEPITYS
A,H
387
AJUGA REPTANS
A,H
388
ALANINE
A,E
389
ALANYLGLUTAMIN
E
390
ALARIA ESCULENTA A,H
Only for use in oral medicines.

Iodine is a mandatory component of
Alaria esculenta.
Only for external use when the
concentration of iodine in the
medicine (excluding salts derivatives
or iodophors) is more than 2.5%.
Only for internal use when the
71
Schedule 1
medicine contains less than 300

micrograms of iodine per maximum
The indication 'For mineral (may state
the mineral) supplementation' is only
permitted for use when the medicine is
for oral and sublingual use.
391
ALBIZIA
JULIBRISSIN
A,H
392
ALBIZIA LEBBECK
A,H
393
ALCEA ROSEA
A,H
394
ALCHEMILLA
ALPINA
A,H
395
ALCHEMILLA
ARVENSIS
A,H
396
ALCHEMILLA
VULGARIS
A,H
397
ALETRIS FARINOSA
A,H
398
ALETRIS SPICATA
A,H
399
ALEURITES
MOLUCCANUS SEED
OIL

dermal application.
400
ALFADEX

The maximum daily dose must
provide no more than 6 g of alfadex.
401
ALGINIC ACID
402
ALISMA ORIENTALE
A,H
403
ALISMA PLANTAGO
AQUATICA
A,H
404
ALKANNA
TINCTORIA
A,H
72
Schedule 1
405
ALKYL (C12-15)
BENZOATE

in the eye.
406
ALLANTOIN
407
ALLIARIA
PETIOLATA
A,H
408
ALLIUM CEPA
A,H
409
ALLIUM
FISTULOSUM
A,H
410
ALLIUM
HIEROCHUNTINUM
A,H
411
ALLIUM
MACROSTEMON
A,H
412
ALLIUM ODORUM
A,H
413
ALLIUM PORRUM
A,H
414
ALLIUM SATIVUM
A,E,H
415
ALLIUM
SCHOENOPRASUM
A,H
416
ALLIUM URSINUM
A,H
417
ALLO-OCIMENE

dermal application.

fragrance.
418
ALLURA RED AC
Permitted for use as a colour for oral

and topical use.
73
Schedule 1
419
ALLURA RED AC
ALUMINIUM LAKE

and topical use.
420
ALLYL ALPHAIONONE

no more than 5%.
must be no more 1%.
421
ALLYL AMYL
GLYCOLATE

fragrance.
422
ALLYL CAPRYLATE

flavour.
no more than 5%.
423
ALLYL
CYCLOHEXANEPRO
PIONATE

no more than 5%.
must be no more 1%.
424
ALLYL
CYCLOHEXYLOXYA
CETATE

74
Schedule 1

no more than 5%.
must be no more 1%.
425
ALLYL
HEPTANOATE

no more than 5%.
must be no more 1%.
426
ALLYL HEPTYLATE

flavour.
no more than 5%.
427
ALLYL HEXANOATE

no more than 5%.
must be no more 1%.
428
ALLYL
ISOTHIOCYANATE

flavour.
75
Schedule 1
no more than 5%.

429
ALLYL
PHENOXYACETATE

no more than 5%.
must be no more 1%.
430
ALLYL TIGLATE

flavour.
no more than 5%.
431
ALMOND
432
ALMOND OIL
A,E,H
Amygdalin and hydrocyanic acid are

mandatory components of Almond oil.
The concentration of Amygdalin in the
medicine must be 0%.
The concentration of hydrocyanic acid
in the medicine must be no more than
1 microgram/kg or 1 microgram/L or
0.0000001%.
433
ALNUS GLUTINOSA
A,H
434
ALNUS INCANA
SUBSP. RUGOSA
A,H
435
ALOE BARBADENSIS
A,E
When the route of administration is

oral or sublingual, Hydroxyanthracene
derivatives calculated as anhydrous
barbaloin is a mandatory component
of Aloe barbadensis.
When used in oral medicines, if the
76
Schedule 1
maximum recommended daily dose

contains more than 10 mg of
hydroxyanthracene derivatives the
warning statements on the medicine
label:
- (CHILD3) 'Use in children under 12
years is not recommended'
- (LAX2) 'Prolonged use may cause
serious bowel problems'
- (LAX3) 'Do not use when abdominal
pain, nausea or vomiting are present,
or if you develop diarrhoea. If you are
pregnant or breast feeding, seek the
advice of a healthcare professional
before taking this product' (or words to
that effect)
- (S) 'If symptoms persist consult your
healthcare practitioner' (or words to
that effect)
When promoted or marketed as a
laxative, the medicine requires the
medicine label:
- (LAX1) 'Drink plenty of water' (or
words to that effect)
When not promoted or marketed as
following warning statements on the
medicine label:
medicine label:
- (LAX5) 'This product contains [name
77
Schedule 1
of the herb(s) or the chemical

component(s)]'
- (LAX4) 'This product may have
laxative effect'
contains less than 10 mg of
hydroxyanthracene derivatives and is
promoted or marketed as laxative, the
label:
that effect).
436
ALOE FEROX
A,E,H

of Aloe ferox.
label:
78
Schedule 1

before taking this product [or words to
that effect]'
healthcare practitioner [or words to
that effect]'.
medicine label:
- (LAX1) 'Drink plenty of water [or
words to that effect]'
medicine label:
component(s)]'
laxative effect'
label:
79
Schedule 1

that effect]'
437
ALOE PERRYI
A,H

of Aloe perryi.
label:
that effect]'
that effect]'.
medicine label:
80
Schedule 1

medicine label:
component(s)]'
laxative effect'
label:
that effect]'
438
ALOE VERA
A,E,H

of Aloe vera.
81
Schedule 1

label:
that effect]'
that effect]'.
medicine label:
medicine label:
component(s)]'
laxative effect'
82
Schedule 1

label:
that effect]'
439
ALOES BARBADOS
A,H

of Aloes barbados.
label:
that effect]'
83
Schedule 1
that effect]'.
medicine label:
medicine label:
component(s)]'
laxative effect'
label:
that effect]'
440
ALOES CAPE
A,H

84
Schedule 1

of Aloes cape.
label:
that effect]'
that effect]'.
medicine label:
medicine label:
component(s)]'
85
Schedule 1
laxative effect'
label:
that effect]'
441
ALOYSIA
CITRODORA
A,H
442
ALPHA-AMYL
CINNAMALDEHYDE

no more than 5%.
must be no more 1%.
443
ALPHA-AMYL
CINNAMYL
ALCOHOL

flavour.
no more than 5%.
86
Schedule 1
444
ALPHA-CEDRENE
EPOXIDE

fragrance.
445
ALPHADAMASCONE

no more than 5%.
must be no more 1%.
446
ALPHA-FARNESENE

no more than 5%.
must be no more 1%.
447
ALPHA-FURFURYL
OCTANOATE

flavour.
no more than 5%.
448
ALPHAHEXYLCINNAMALD
EHYDE

87
Schedule 1
no more than 5%.

must be no more 1%.
449
ALPHA-IONOL

no more than 5%.
must be no more 1%.
450
ALPHA-IONONE

dermal application.
451
ALPHA-IRONE

no more than 5%.
must be no more 1%.
452
ALPHA-ISO-METHYL
IONONE

no more than 5%.
must be no more 1%.
453
ALPHA-METHYL

88
Schedule 1
ANISALACETONE
flavour.
no more than 5%.
454
ALPHA-METHYL
BENZYL ALCOHOL

flavour.
no more than 5%.
455
ALPHA-METHYL
BUTYRALDEHYDE

flavour.
no more than 5%.
456
ALPHA-METHYL
BUTYRIC ACID

no more than 5%.
must be no more 1%.
457
ALPHA-METHYL
CINNAMALDEHYDE

no more than 5%.
must be no more 1%.
89
Schedule 1
458
ALPHA-METHYL
FURFURAL

flavour.
no more than 5%.
459
ALPHA-METHYL
NAPHTHYL KETONE

fragrance.
460
ALPHAMETHYLCINNAMYL
ALCOHOL

fragrance.
461
ALPHA-N-METHYL
IONONE

no more than 5%.
must be no more 1%.
462
ALPHAPHELLANDRENE

dermal application.
463
ALPHA-PINENE

no more than 5%.
90
Schedule 1

must be no more 1%.
464
ALPHA-SINENSAL

flavour.
no more than 5%.
465
ALPHA-TERPINENE

no more than 5%.
must be no more 1%.
466
ALPHA-TERPINEOL

no more than 5%.
must be no more 1%.
467
ALPHA LIPOIC ACID
468
ALPINIA GALANGA
A,H
469
ALPINIA
HAINANENSIS
A,H
470
ALPINIA
OFFICINARUM
A,H
471
ALPINIA
A,H
91
Schedule 1
OXYPHYLLA
472
ALSIDIUM
HELMINTHOCHORT
ON
A,H

Alsidium helminthochorton.
concentration of available iodine in the
473
ALSTONIA BOONEI
A,H
474
ALSTONIA
CONSTRICTA
475
ALTERNANTHERA
PHILOXEROIDES
A,H
476
ALTERNARIA
ALTERNATA
A,H
477
ALTHAEA
OFFICINALIS
A,E,H
478
ALUM
DODECAHYDRATE
A,E,H
479
ALUMINIUM
CHLOROHYDRATE

dermal application.
480
ALUMINIUM
CITRATE

dermal application.
481
ALUMINIUM
DISTEARATE

dermal application.
482
ALUMINIUM

92
Schedule 1
HYDROXIDE
dermal application.
483
ALUMINIUM
HYDROXIDE
HYDRATE

dermal application.
484
ALUMINIUM
MAGNESIUM
SILICATE
485
ALUMINIUM
MONOSTEARATE

dermal application.
486
ALUMINIUM OXIDE
E,H
When used as an excipient ingredient,

only for use in topical medicines for
dermal application.
When used as an active ingredient,
only for use in homoeopathic
medicines.
487
ALUMINIUM
SILICATE
E,H

homoeopathic or excipient ingredient.
the medicine is only for use in topical
medicines for dermal application.
488
ALUMINIUM
SODIUM SILICATE
When for oral or sublingual use and

the total amount of sodium from all
ingredients in the maximum daily dose
is more than 120 mg, the medicine
- (SODIUM) The recommended daily
dose of this medicine contains [state
quantity and units] of sodium (or
words to that effect).
489
ALUMINIUM
STARCH
OCTENYLSUCCINAT
E

490
ALUMINIUM
93
Schedule 1
STEARATE
491
ALUMINIUM
SULFATE HYDRATE
dermal application.
E

flavour.
no more than 5%.
492
AMARANTH

and topical use.
493
AMARANTH
ALUMINIUM LAKE

and topical use
494
AMARANTHUS
HYBRIDUS
A,H
495
AMARANTHUS
RETROFLEXUS
A,H
496
AMBERGRIS
EXTRACT
497
AMBRETTE SEED
OIL

flavour.
no more than 5%.
498
AMBRETTOLIDE

no more than 5%.
must be no more 1%.
499
AMBRINOL

94
Schedule 1
fragrance.
500
AMBROSIA
ARTEMISIIFOLIA
A,H
501
AMBROSIA
PSILOSTACHYA
A,H
502
AMINOBENZOIC
ACID

sunscreens.
in the eye.
503
AMINOCAPROIC
ACID

flavour.
no more than 5%.
504
AMINOPROPYL
ASCORBYL
PHOSPHATE

in the eye.
505
AMMI VISNAGA
A,H

Ammi visnaga in the product must be
no more than 10mg/Kg or 10mg/L or
0.001%.
506
AMMONIA
E,H
Only for use as an active homoepathic

or excipient ingredient.
95
Schedule 1

the medicine is only for use in topical
507
AMMONIO
METHACRYLATE
COPOLYMER
508
AMMONIUM
ACRYLATES
COPOLYMER

dermal application.
509
AMMONIUM
ACRYLATES/ACRYL
ONITROGENS
COPOLYMER

dermal application.
510
AMMONIUM
ACRYLOYLDIMETH
YLTAURATE/STEAR
ETH-8
METHACRYLATE
COPOLYMER

included in topical medicines intended
for use in the eye.
AMMONIUM
ACRYLOYLDIMETH
YLTAURATE/VP
COPOLYMER
511

for use in the eye.
512
AMMONIUM
BICARBONATE
A,H
When used as an active ingredient, can

only be supplied as an uncompounded
medicine substance packed for retail
sale, and must comply with an
uncompounded substance monograph
of the British Pharmacopeia.
513
AMMONIUM
BROMIDE

96
Schedule 1
514
AMMONIUM
CARBONATE
E,H

515
AMMONIUM
CHLORIDE
A,E,H

homoeopathic medicines or as an
uncompounded medicine substance
packed for retail sale.
When used as an uncompounded
medicine substance the ingredient
must comply with an uncompounded
substance monograph of the British
Pharmacopeia.
If used as an excipient ingredient then
the medicine is only for topical use for
dermal application.
516
AMMONIUM
GLYCYRRHIZINATE
517
AMMONIUM IODIDE
Only for use an active ingredient in

homoeopathic medicines.
518
AMMONIUM
LACTATE

for use in the eye.
519
AMMONIUM
LAURETH SULFATE

dermal application.
520
AMMONIUM
LAURYL SULFATE

dermal application.
521
AMMONIUM
PHOSPHATE MONOBASIC

dermal application.
522
AMMONIUM
POLYACRYLATE

in the eye.
97
Schedule 1

523
AMMONIUM
POLYACRYLOYLDI
METHYL TAURATE

in the eye.
The concentration must be no more
than 3%.
524
AMMONIUM
SULFIDE

flavour.
no more than 5%.
525
AMOMUM
AROMATICUM
A,H
526
AMOMUM
VILLOSUM
A,H
527
AMORPHOPHALLUS
KONJAC
A,H
528
AMPELODESMOS
MAURITANICUS
A,H
529
AMPELOPSIS
JAPONICA
A,H
530
AMYL ACETATE

dermal application.
531
AMYL ALCOHOL

Only for use when the dosage form is

not tablet.

no more than 5%.
98
Schedule 1
must be no more 1%.

532
AMYL BENZOATE

fragrance.
533
AMYL BUTYRATE

no more than 5%.
must be no more 1%.
534
AMYL CAPROATE

no more than 5%.
must be no more 1%.
535
AMYL CINNAMATE

flavour.
no more than 5%.
536
AMYL CINNAMIC
ALCOHOL

fragrance.
99
Schedule 1

537
AMYL FORMATE

no more than 5%.
must be no more 1%.
538
AMYL
ISOBUTYRATE

flavour.
no more than 5%.
539
AMYL
ISOVALERATE

no more than 5%.
must be no more 1%.
540
AMYL OCTANOATE

flavour.
no more than 5%.
541
AMYL
PHENYLACETATE

flavour.
100
Schedule 1

no more than 5%.
542
AMYL PROPIONATE

flavour.
no more than 5%.
543
AMYL SALICYLATE

fragrance.
544
AMYL VALERATE

fragrance.
545
AMYL VINYL
CARBINOL

no more than 5%.
must be no more 1%.
546
AMYL VINYL
CARBINYL
ACETATE

101
Schedule 1
no more than 5%.

must be no more 1%.
547
AMYLASE
Amylase must be derived from

Aspergillus oryzae, and comply with
the relevant compositional guideline.
When used in a divided preparation,
the allowed unit is Alpha-amylase
dextrinising unit or Thousand alphaamylase dextrinising unit.
When used as an undivided
preparation, the allowed unit is
Thousand alpha-amylase dextrinising
unit per gram or Dextrinising unit per
gram.
548
AMYLCYCLOHEXYL
ACETATE (MIXED
ISOMERS)

fragrance.
549
AMYLOPECTIN

flavour.
no more than 5%.
550
AMYRIS
BALSAMIFERA
A,H
551
AMYRIS OIL WEST

INDIAN
A,E,H
552
ANACARDIUM
OCCIDENTALE
A,H
102
Schedule 1
553
ANACYCLUS
PYRETHRUM
A,H
554
ANACYSTIS
NIDULANS
FERMENT

in the eye.
555
ANAESTHETIC
ETHER
556
ANAGALLIS
ARVENSIS
A,H
557
ANAMIRTA
COCCULUS
A,H

Picrotoxin is a mandatory component

of Anamirta cocculus.
The concentration of picrotoxin in the
medicine must be no more than 10
mg/kg or 10 mg/L or 0.001%.
558
ANANAS COMOSUS
A,E,H
559
ANAPHALIS SINICA
A,H
560
ANDROGRAPHIS
PANICULATA
A,H
561
ANEMARRHENA
ASPHODELOIDES
A,E,H
562
ANEMONE ALTAICA
A,H
563
ANEMONE
CHINENSIS
A,H
564
ANEMONE
HEPATICA
A,H
565
ANEMONE
PULSATILLA
A,H
566
ANEMONE
RADDEANA
A,H
103
Schedule 1
567
ANETHOLE
A,E

only for use in medicated space sprays
and medicated throat lozenges.
568
ANETHOLEA
ANISATA

flavour.
no more than 5%.
569
ANETHUM
GRAVEOLENS
A,E,H
570
ANGELICA
ACUTILOBA
A,H
571
ANGELICA
ANOMALA
A,H
572
ANGELICA
ARCHANGELICA
A,E,H
573
ANGELICA
ATROPURPUREA
A,H
574
ANGELICA
DAHURICA
A,E,H
575
ANGELICA
DECURSIVA
A,H
576
ANGELICA
POLYMORPHA
A,E,H
577
ANGELICA
PUBESCENS
A,E,H
578
ANGELICA ROOT
DRY
A,H
579
ANGELICA ROOT
OIL
A,E,H
580
ANGELICA SEED OIL
A,E,H
104
Schedule 1
581
ANGELICA STEM
582
ANIBA
ROSAEODORA
A,E,H
583
ANISALDEHYDE

no more than 5%.
must be no more 1%.
584
ANISE ALCOHOL

no more than 5%.
must be no more 1%.
585
ANISE OIL
A,E,H
When the concentration of Anise oil in

the preparation is more than 50% the
nominal capacity of the container must
be no more than 50 mL.
When the concentration of Anise oil in
the preparation is more than 50% and
the nominal capacity of the container
is 50 mL or less, a restricted flow
insert must be fitted on the container.
The medicine requires the following
label:
- (CHILD) 'Keep out of reach of
children (or word to that effect)'
105
Schedule 1
586
ANISEED

no more than 5%.
587
ANISEED DRY
A,E,H
588
ANISEED POWDER
A,E,H
589
ANISIC ACID

fragrance.
590
ANISYL ACETATE

no more than 5%.
must be no more 1%.
591
ANISYL ACETONE

no more than 5%.
106
Schedule 1
must be no more 1%.

592
ANISYL FORMATE

no more than 5%.
must be no more 1%.
593
ANISYL
PROPIONATE

flavour.
no more than 5%.
594
ANNATTO
595
ANOGEISSUS
LATIFOLIA
A,E,H
596
ANTENNARIA
DIOICA
A,E,H
597
ANTHOCYANINS
598
ANTHOXANTHUM
ODORATUM
A,H
599
ANTHRISCUS
CEREFOLIUM
A,H
600
ANTHYLLIS
VULNERARIA
A,H
601
ANTIMONY
POTASSIUM
TARTRATE
TRIHYDRATE

and topical use.

107
Schedule 1
602
ANTIMONY
TRISULFIDE

603
APIUM
GRAVEOLENS
A,E,H
604
APOCYNUM
CANNABINUM
A,H

Apocynum cannabinum in the
medicine must be no more than
10mg/Kg or 10mg/L or 0.001%.
605
APOMORPHINE
HYDROCHLORIDE
HEMIHYDRATE

606
APPLE
607
APPLE CIDER
VINEGAR
608
APPLE ESSENCE
NATURAL

flavour.
no more than 5%.
609
APPLE EXTRACT

flavour.
no more than 5%.
610
APPLE FIBRE
611
APRICOT
612
APRICOT KERNEL
OIL PEG-6 ESTERS
613
AQUILARIA
MALACCENSIS
A,H
614
AQUILARIA
A,H
Only for use as an excipient in topical

108
Schedule 1
SINENSIS
615
AQUILEGIA
VULGARIS
A,H
616
ARABINOGALACTA
N - LARIX
A,E

The ingredient must be derived from
Larix occidentalis or Larix larcinia.
The maximum recommended daily
dose must be no more than 15 grams.
The concentration of polysaccharides
in the medicine must be equal to or
more than 85%.
617
ARACHIDONIC ACID

dermal application.
618
ARACHIDYL
ALCOHOL

in the eye.
619
ARACHIDYL
GLUCOSIDE

in the eye.
than 0.5%.
620
ARACHIDYL
PROPIONATE

dermal application.
621
ARACHIS
HYPOGAEA
A,E,H

label:
- (PEANUT) Contains [insert
ingredient name].
622
ARACHIS OIL
A,E,H

109
Schedule 1
label:
- (PEANUT) Contains [insert
ingredient name].
623
ARALIA CORDATA
A,H
624
ARALIA HISPIDA
A,H
625
ARALIA
NUDICAULIS
A,H
626
ARALIA RACEMOSA
A,H
627
ARCTIUM LAPPA
A,E,H
628
ARCTIUM MINUS
A,H
629
ARCTOSTAPHYLOS
UVA-URSI
A,E,H
630
ARDISIA JAPONICA
A,H
631
ARECA CATECHU
A,H
Arecoline is a mandatory component

of Areca catechu.
The concentration of arecoline in the
mg/Kg or 10 mg/L or 0.001%.
632
ARGANIA SPINOSA
KERNEL OIL

for use in the eye or on damaged skin.
than 5% in the medicine.
633
ARGININE
A,E,H

dermal application.
label:
- (ARGIN1) 'This medicine contains
arginine and is intended to be applied
to the skin only and not to the mucosa
110
Schedule 1
- vagina or rectum.'
634
ARGININE
FERULATE

in the eye.
635
ARISAEMA
ATRORUBENS
A,H
The maximum daily dose must be no

more than the equivalent of 1mg of the
dry herbal material.
636
ARISAEMA
CONSANGUINEUM
A,H

637
ARISAEMA
JAPONICUM
A,H

638
ARMORACIA
RUSTICANA
A,E,H
Volatile oil components (of Armoracia

rusticana) is a mandatory component
of Armoracia rusticana.
dose must contain no more than 20 mg
of volatile oil components (of
Armoracia rusticana).
639
ARNEBIA
EUCHROMA
A,H
640
ARNICA FLOWER
DRY
A,H
When for use other than topically on

unbroken skin, the maximum
recommended daily dose must be no
more than 1mg of the equivalent dry
flower of Arnica montana.
641
ARNICA MOLLIS
A,H

111
Schedule 1
642
ARNICA MONTANA
A,H
643
ARRHENATHERUM
ELATIUS
A,H
644
ARROWROOT
A,E,H
645
ARSENIC TRIIODIDE

herbal material of arnica montana.

The concentration of arsenic in the
0.001%.
646
ARSENIC TRIOXIDE

The concentration of arsenic in the
0.001%.
647
ARTEMISIA
ABROTANUM
A,H
Thujone is a mandatory component of

Artemisia abrotanum. The
concentration of thujone from
Artemisia abrotanum in the medicine
648
ARTEMISIA
ABSINTHIUM
A,H

Artemisia absinthium.
The concentration of thujone from
Artemisia absinthium in the medicine
649
ARTEMISIA ANNUA
A,H

Artemisia annua.
Artemisia annua in the medicine must
be no more than 4%.
650
ARTEMISIA
A,H
112
Schedule 1
ARBORESCENS
Artemisia arborescens.
Artemisia arborescens in the medicine
651
ARTEMISIA ARGYI
A,H

Artemisia argyi.
Artemisia argyi in the medicine must
be no more than 4%.
652
ARTEMISIA
DRACUNCULUS
A,E,H

Artemisia dracunculus.
Artemisia dracunculus in the medicine
653
ARTEMISIA FRIGIDA
A,H

Artemisia frigida.
Artemisia frigida in the medicine must
be no more than 4%.
654
ARTEMISIA HERBAALBA
A,H

Artemisia herba-alba.
Artemisia herba-alba in the medicine
655
ARTEMISIA
MARITIMA
A,H

Artemisia maritima.
Artemisia maritima in the medicine
656
ARTEMISIA OIL

113
Schedule 1
no more than 5%.

must be no more 1%.
The concentration of thujone in the
657
ARTEMISIA
PALLENS
A,E,H

Artemisia pallens.
Artemisia pallens in the medicine must
be no more than 4%.
658
ARTEMISIA
TRIDENTATA
A,H

Artemisia tridentata.
Artemisia tridentata in the medicine
659
ARTEMISIA
VULGARIS
A,E,H

Artemisia vulgaris.
Artemisia vulgaris in the medicine
660
ARTERY
661
ARTHROSPIRA
MAXIMA
A,H
662
ARTHROSPIRA
PLATENSIS
A,H
663
ARUM MACULATUM
A,H
664
ASAFOETIDA GUM
A,H
665
ASAFOETIDA OIL



114
Schedule 1
flavour.
no more than 5%.
666
ASARUM
EUROPAEUM
A,H
667
ASARUM
HETEROTROPOIDES
A,H
668
ASARUM OIL
669
ASARUM SIEBOLDII
A,E,H
670
ASCLEPIAS
TUBEROSA
A,H
671
ASCOPHYLLUM
NODOSUM
A,E,H

Ascophyllum nodosum.
for oral or sublingual use.
672
ASCORBIC ACID
A,E

medicine label:
- (VIT) Vitamins can only be of
is inadequate. or Vitamin
115
Schedule 1
balanced diet.
673
ASCORBYL
GLUCOSIDE

in the eye.
674
ASCORBYL
METHYLSILANOL
PECTINATE

dermal application.
675
ASCORBYL
PALMITATE
A,E
When used as an active ingredient for

oral use, the maximum recommended
daily dose must contain no more than
100mg of ascorbyl palmitate.
medicine label:
balanced diet.
676
ASCORBYL
TOCOPHERYL
MALEATE
Only for use as an ingredient in topical

medicines for dermal application and
not to be included in medicines
intended for use in the eye.
677
ASPALATHUS
LINEARIS
A,E,H
678
ASPARAGINE
A,E
679
ASPARAGOPSIS
SULFATED

116
Schedule 1
GALACTANS

680
ASPARAGUS
E,H

681
ASPARAGUS
COCHINCHINENSIS
A,H
682
ASPARAGUS
OFFICINALIS
A,E,H
683
ASPARAGUS
RACEMOSUS
A,H
The plant part must be dried, peeled

root, and water extracts or
ethanol/water extracts (containing up
to 45% ethanol) of the dried, peeled
root.
684
ASPARTAME
When for oral use, the medicine

- (PKU) 'Phenylketonurics are warned
that this product contains
phenylalanine (or words to that effect)'
label:
- (ASPAR) 'Contains aspartame'
685
ASPARTIC ACID
A,E
686
ASPERGILLUS
ORYZAE
A,E,H
687
ASTAXANTHIN
ESTERS EXTRACTED
FROM
HAEMATOCOCCUS
PLUVIALIS

Astaxanthin (of Haematococcus
pluvialis) is a mandatory component
of astaxanthin esters extracted from
Haematococcus pluvialis.
The maximum daily dose must contain
no more than 12mg of Astaxanthin (of
117
Schedule 1
Haematococcus pluvialis).
688
ASTER NOVI-BELGII
A,H
689
ASTER TATARICUS
A,H
690
ASTRAGALUS
ADSURGENS
A,H
691
ASTRAGALUS
COMPLANATUS
A,H
692
ASTRAGALUS
EXCARPUS
A,H
693
ASTRAGALUS
GUMMIFER
A,E,H
694
ASTRAGALUS
LENTIGINOSUS
A,H
695
ASTRAGALUS
MEMBRANACEUS
A,E,H
696
ASTRAGALUS
PENDULIFLORUS
A,H
697
ASTROCARYUM
MURUMURU SEED
TRIGLYCERIDES

698
ATRACTYLODES
JAPONICA
A,H
699
ATRACTYLODES
LANCEA
A,H
700
ATRACTYLODES
MACROCEPHALA
A,H
701
ATROPA
BELLADONNA
A,H
Alkaloids calculated as hyoscyamine

and atropine are mandatory
components of Atropa belladonna.
118
Schedule 1
The concentration of alkaloids

calculated as hyoscyamine in the
micrograms/Kg or 300 micrograms/L
or 0.00003%.
The concentration of atropine in the
micrograms/kg or 100 micrograms/L
or 0.00001%.
702
ATROPINE SULFATE
MONOHYDRATE

703
ATTALEA SPECIOSA

dermal application.
704
ATTAPULGITE ACTIVATED

sale and must comply with an
705
AURA BAURANTIOL

fragrance.
706
AUREOBASIDIUM
PULLULANS
A,H
707
AVENA FATUA
A,H
Gluten is a mandatory component of

Avena fatua when the plant part is
seed and the route of administration is
other than topical and mucosal.
other than topical or mucosal, the
label:
119
Schedule 1
- (GLUTEN) 'Contains [insert name of

ingredient]' or words to that effect.
708
AVENA SATIVA
A,E,H

Avena sativa when the plant part is
label:
709
AVOCADO
710
AVOCADO OIL
711
AVOCADO OIL
UNSAPONIFIABLES

dermal application.
712
AZADIRACHTA
INDICA
A,H
The ingredient can only be derived

from the plant part seed and must be
cold pressed or debitterised oil.
Debitterised neem seed oil means
highly purified oil from the neem seed
containing only fatty acids and
glycerides of fatty acids.
Cold pressed Azadirachta indica seed
oil must be for topical use for dermal
application only.
When the concentration of cold
pressed Azadirachta indica seed oil is
more than 1%, a child resistant closure
and restricted flow insert must be
fitted to the container.
label:
- (PREGNT2) 'Do not use if pregnant
120
Schedule 1
or likely to become pregnant (or words

to that effect)'
- (NTAKEN) 'Not to be taken (or
words to that effect)'
children (or words to that effect)
713
AZOVAN BLUE

topical use.
714
AZULENE

dermal application.
121
Schedule 1
Column 1
715
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine

BACKHOUSIA
CITRIODORA
A,E,H
The herbal substance must be derived

from leaf oil only.
dermal application.
must be no more than 10g/kg or 10g/L
or 1%.
label:
- (IRRIT) 'If irritation develops discontinue use'
- (PREGNT) 'Not recommended for
use by pregnant and lactating women'
(or words to that effect).
716
BACOPA MONNIERI
A,H
717
BALLOTA NIGRA
A,H
718
BALM OF GILEAD
BUD DRY
A,H
719
BALM OF GILEAD
BUD POWDER
A,H
720
BALSAM COPAIBA

fragrance.
Schedule 1

721
BAMBUSA
BREVIFLORA
A,E,H
722
BAMBUSA TEXTILIS
A,H
723
BANANA
724
BANANA
DISTILLATE

flavour.
no more than 5%.
725
BAPHICACANTHUS
CUSIA
A,H
726
BAPTISIA CONFUSA
A,H
727
BAPTISIA
TINCTORIA
A,H
728
BARBAREA
VULGARIS
A,H
729
BARIUM
CARBONATE

730
BARIUM CHLORIDE

731
BARIUM SULFATE

dermal application.
732
BARLEY

Barley when the route of
administration is other than topical and
mucosal.
label:
Schedule 1

733
BARLEY BRAN

Barley bran when the route of
mucosal.
label:
734
BARLEY GERM

Barley germ when the route of
mucosal.
label:
735
BARLEY LEAF
736
BASIC BUTYLATED
METHACRYLATE
COPOLYMER
737
BASIC FUCHSIN
Only for use as a colour ingredient in

topical medicines for dermal
application.
738
BASIC RED 1
Only for use as a colour in topical

intended for use in the eye or on
damaged skin.
Schedule 1

739
BASIC VIOLET 11:1
Only for use as a colour in topical

not intended for use in the eye or on
damaged skin.
740
BASIL OIL
COMOROS
A,E,H
Methyl chavicol is a mandatory

component of Basil oil Comoros.
When the concentration of Methyl
chavicol in the medicine is more than
5%, the nominal capacity of the
container must be no more than 25mL.
5% and the nominal capacity of the
container is 25mL or less, a restricted
flow insert must fitted on the
container, and the medicine requires
the following warning statement on
the medicine label:
children' (or words to that effect).
741
BASIL OIL
EUROPEAN
A,E,H

component of Basil oil European.
Schedule 1
the medicine label:

742
BASSIA SCOPARIA
A,H
743
BATYL ALCOHOL
744
BAY LEAF
745
BAY OIL
A,E,H

dermal application.
When the concentration of Bay oil in

the medicine is more than 25%, the
the medicine is more than 25% and the
nominal capacity of the container is no
more than 15 mL, there must be a
restricted flow insert fitted on the
container.
the medicine is more than 25% and the
nominal capacity of the container is
more than 15 mL, a child resistant
closure and restricted flow insert must
be fitted on the container.
label:
children' (or word to that effect)
- (NTAKEN) 'Not to be taken'
746
BEESWAX SYNTHETIC
747
BEESWAX - WHITE
748
BEESWAX YELLOW
Schedule 1
749
BEESWAX
ABSOLUTE

no more than 5%.
must be no more 1%.
750
BEET RED
751
BEETROOT
E,H
752
BEGONIA
FIMBRISTIPULA
A,H
753
BEHENETH-10

and topical use.

for use in the eye.
Residual levels of ethylene oxide are
to be kept below the level of detection.
754
BEHENIC ACID
If used as an excipient ingredient, the

ingredient can only be in topical
If the medicine is for oral ingestion, it
must not contain more than 383.5 mg
of behenic acid per maximum
755
BEHENOXY
DIMETHICONE

dermal application.
756
BEHENOYL STEARIC
ACID

Schedule 1
for use in the eye.

757
BEHENYL ALCOHOL

dermal application.
758
BELLADONNA HERB
DRY
A,H

components of Belladonna herb dry.
medicine and must be no more than
300 micrograms/Kg or 300
micrograms/L or 0.00003%.
or 0.00001%.
759
BELLADONNA HERB
POWDER
A,H

components of Belladonna herb
powder.
or 0.00003%.
The concentration of atropinei n the
or 0.00001%.
760
BELLADONNA HERB
PREPARED
A,H

components of Belladonna herb
prepared and must be declared in the
application.
calculated as hyoscyamine from all
Schedule 1
ingredients in the product must be no

more than 300 micrograms/Kg or 300
The concentration of atropine from all
more than 100 micrograms/kg or 100
761
BELLIS PERENNIS
A,H
762
BEMOTRIZINOL

topical sunscreens for dermal
application.
763
BENINCASA
HISPIDA
A,E,H
764
BENTONITE
765
BENZALDEHYDE
766
BENZALDEHYDE
GLYCERYL ACETAL

flavour.
no more than 5%.
767
BENZALKONIUM
CHLORIDE

dermal application and nasal sprays.
768
BENZETHONIUM
CHLORIDE
Only for use as a preservative in

application.
The medicine requires the warning
statement:
Schedule 1
- (BNZTHC) 'Contains Benzethonium

chloride' (or words to that effect).
769
BENZOIC ACID
E,H
Medicines containing benzoates

require the following warning
- (TBNZO8) Contains benzoates' (or
words to this effect) if the medicine
contains two or more benzoate sources
or Contains [insert the approved name
of benzoate used] (or words to this
effect) if product contains one
benzoate source.
770
BENZOIN

fragrance.
771
BENZOIN SIAM
A,E,H
772
BENZOIN SUMATRA
A,E,H
773
BENZOPHENONE

no more than 5%.
must be no more 1%.
774
BENZYL ACETATE

no more than 5%.
Schedule 1

must be no more 1%.
775
BENZYL ACETONE

fragrance.
776
BENZYL ALCOHOL

statement:
- (BNZALC) 'Contains benzyl alcohol
[quantity]' (or words to that effect).
777
BENZYL BENZOATE

dermal application.
require the warning statement:
- (TBNZO8) 'Contains benzoates' (or
or 'Contains [insert the approved name
of benzoate used]' (or words to this
benzoate source.
778
BENZYL BUTYRATE

no more than 5%.
must be no more 1%.
779
BENZYL
CINNAMATE

10
Schedule 1
in the eye.
780
BENZYL DIMETHYL
CARBINYL-NBUTYRATE

flavour.
no more than 5%.
781
BENZYL FORMATE

no more than 5%.
must be no more 1%.
782
BENZYL ISOAMYL
ETHER

fragrance.
783
BENZYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
784
BENZYL
ISOVALERATE

11
Schedule 1
no more than 5%.
must be no more 1%.
785
BENZYL LAURATE

fragrance.
786
BENZYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
787
BENZYL
PROPIONATE

no more than 5%.
must be no more 1%.
788
BENZYL
SALICYLATE

12
Schedule 1

no more than 5%.
must be no more 1%.
789
BENZYLIDENE
ACETONE

no more than 5%.
790
BENZYLIDENE
CAMPHOR
SULFONIC ACID
791
BERBERIS
AQUIFOLIUM
A,H
792
BERBERIS
ARISTATA

sunscreens for dermal application.
The concentration in the preparation
must be no more than 6% (as acid).

label:
793
BERBERIS
VULGARIS
A,E,H
794
BERGAMOT OIL

13
Schedule 1
no more than 5%.

must be no more 1%.
795
BERGAMOT OIL
BERGAPTEN-FREE

no more than 5%.
must be no more 1%.
796
BERGAMOT OIL
COLDPRESSED
A,E,H
When for internal use, Oxedrine is a

mandatory component of bergamot oil
coldpressed.
dose must not provide more than 30
mg of Oxedrine.
The ingredient bergamot oil
coldpressed is subject to the following
conditions :
a) steam distilled or rectified;
b) in preparations for internal use;
c) in preparations containing 0.4 % or
less of bergamot oil;
d) in soaps or bath and shower gels
that are washed off the skin;
e) The medicine requires the following
label:
- (SENS) 'Application to skin may
increase sensitivity to sunlight' (or
14
Schedule 1
797
BERGAMOT OIL
TERPENELESS

flavour.
no more than 5%.
798
BERTHOLLETIA
EXCELSA
A,E,H
799
BETACARYOPHYLLENE

no more than 5%.
must be no more 1%.
800
BETADAMASCENONE

no more than 5%.
must be no more 1%.
801
BETA-DAMASCONE

no more than 5%.
must be no more 1%.
15
Schedule 1
802
BETA-HOMO
CYCLOCITRAL

flavour.
no more than 5%.
803
BETA-HYDROXYBETAMETHYLBUTYRIC
ACID
804
BETA-IONONE

no more than 5%.
must be no more 1%.
805
BETA-ISO-METHYL
IONONE

fragrance.
806
BETA-METHYL
NAPHTHYL KETONE

no more than 5%.
must be no more 1%.
807
BETA-N-METHYL

16
Schedule 1
IONONE
no more than 5%.
must be no more 1%.
808
BETA-NAPHTHOL
ETHYLETHER

no more than 5%.
must be no more 1%.
809
BETA-NAPHTHOL
METHYL ETHER

no more than 5%.
must be no more 1%.
810
BETA-NAPHTHYL
ISOBUTYL ETHER

no more than 5%.
must be no more 1%.
811
BETA-PINENE
17
Schedule 1

no more than 5%.
812
BETA-TOCOPHEROL
813
BETA RAPA
A,E,H
814
BETA VULGARIS
A,E,H
815
BETA,4DIMETHYLCYCLOH
EX-3-ENE-1PROPAN-1-AL
816
BETACAROTENE
A,E
817
BETADEX
818
BETAGLUCAN

fragrance.

in the eye.
819
BETAINE
820
BETAINE
HYDROCHLORIDE
821
BETULA LENTA
A,H

dermal application.
Methyl salicylate is a mandatory

component of Betula lenta.
18
Schedule 1
dermal application.
The concentration of methyl salicylate
0.001%.
When the concentration of methyl
salicylate in a liquid preparation is
more than 5%, and the dosage form is
other than spray, the medicine requires
child resistant packaging.
spray, the medicine does not require
child resistant packaging but the
delivery device must be engaged into
the container in such a way that
prevents it from being readily
removed, direct suction through the
delivery device results in delivery of
no more than one dosage unit, and
actuation of the spay device is
ergonomically difficult for young
children to accomplish.
822
BETULA NIGRA
A,H
823
BETULA PENDULA
A,E,H

component of Betula pendula.
dermal application.
The concentration of methyl salicylate
0.001%.
19
Schedule 1

824
BETULA PUBESCENS A,E,H
825
BICYCLO(2.2.1)HEPT
-5-ENE-2CARBOXYLIC ACID,
3-(1METHYLETHYL)-,
ETHYL ESTER,
(1R,2R,3R,4S)-REL-
BICYCLO(2.2.2)OCT5-ENE-2CARBOXALDEHYDE,
6-METHYL-8-(1METHYLETHYL)-
827
BIFIDOBACTERIUM
ADOLESCENTIS
828
BIFIDOBACTERIUM
ANIMALIS
829
BIFIDOBACTERIUM
ANIMALIS SSP
ANIMALIS
830
BIFIDOBACTERIUM
ANIMALIS SSP
LACTIS
826

fragrance.
fragrance.
20
Schedule 1
831
BIFIDOBACTERIUM
BIFIDUM
832
BIFIDOBACTERIUM
BREVE
833
BIFIDOBACTERIUM
INFANTIS
834
BIFIDOBACTERIUM
LACTIS
835
BIFIDOBACTERIUM
LONGUM
836
BILBERRY
837
BIOSACCHARIDE
GUM-1

for use in the eye.
838
BIOTA ORIENTALIS
A,H
839
BIOTIN
A,E

medicine label:
balanced diet.
840
BIRCH LEAF DRY
A,E,H
841
BIRCH TAR OIL

RECTIFIED
A,E,H
842
BIS-DIGLYCERYL
POLYACYLADIPATE
-2

dermal application.
21
Schedule 1
843
BIS-ETHYLHEXYL
HYDROXYDIMETHO
XY
BENZYLMALONATE

in the eye.
844
BIS-MACROGOL 900
METHYL ETHER
DIMETHYL SILANE

845
BIS-PEG-12
DIMETHICONE
BEESWAX

in the eye.
846
847
BIS-STEARYL
ETHYLENEDIAMINE/
NEOPENTYL
GLYCOL/STEARYL
HYDROGENATED
DIMER
DILINOLEATE
COPOLYMER
BISABOLENE

in the eye.

no more than 5%.
must be no more 1%.
848
BISABOLOL
If used as an excipient, the medicine is

22
Schedule 1
dermal application.
849
BITTER ALMOND
OIL

flavour.
no more than 5%.
The absence of amygdalin in the
medicine must be declared.
850
BIXA ORELLANA
A,E,H
851
BLACK COHOSH
DRY
A,H

label:
doctor.'
852
BLACK COHOSH
POWDER
A,H

label:
doctor.'
853
BLACK CURRANT
23
Schedule 1
854
BLACK CURRANT
ABSOLUTE

no more than 5%.
must be no more 1%.
855
BLACK CURRANT
FRESH
A,E,H
856
BLACK CURRANT
SEED OIL

flavour.
no more than 5%.
857
BLACK OF
CURACAO SPIDER
858
BLACK PEPPER OIL
A,E,H
859
BLACK RASPBERRY


flavour.
no more than 5%.
860
BLACKBERRY
861
BLACKBERRY OILS

flavour.
no more than 5%.
862
BLACKBERRY WINE
24
Schedule 1

flavour.
no more than 5%.
863
BLACKCURRANT
ESTERS

flavour.
no more than 5%.
864
BLACKCURRANT
JUICE

flavour.
no more than 5%.
865
BLADDERWRACK
DRY
A,H

Bladderwrack dry.
permitted when the medicine is for
oral or sublingual use.
866
BLADDERWRACK
POWDER
A,H

Bladderwrack powder.
25
Schedule 1

867
BLAINVILLEA
ACMELLA
A,H
868
BLETILLA STRIATA
A,H
869
BLUE FLAG
RHIZOME DRY
A,H
870
BLUE FLAG
RHIZOME POWDER
A,H
871
BLUEBERRY

flavour.
no more than 5%.
872
BLUEBERRY JUICE

no more than 5%.
873
BLUMEA LACERA
A,H
874
BOEHMERIA NIVEA
A,H
26
Schedule 1
875
BOERHAVIA
DIFFUSA
A,H
876
BOERHAVIA REPENS
A,H
877
BOGBEAN LEAF
DRY
A,H
878
BOGBEAN LEAF
POWDER
A,H
879
BOIS DE ROSE OIL
A,E,H
880
BOMBAX CEIBA
A,H
881
BORAGO
OFFICINALIS
A,E,H
882
BORAX
A,E,H
Boron is a mandatory component of

Borax.
The percentage of Boron from Borax
should be calculated based on the
molecular weight of Borax.
dose must provide no more than 6mg
of Boron.
In preparations for dermal use, which
are not for paediatric or antifungal use,
the concentration of boron in the
mg/kg or 3500 mg/L or 0.35%. The
indication 'For mineral (may state the
mineral) supplementation' is only
883
BORAX
PENTAHYDRATE
A,E

Borax Pentahydrate.
The percentage of Boron from Borax
pentahydrate should be calculated
based on the molecular weight of
Borax Pentahydrate.
27
Schedule 1

of Boron from Borax pentahydrate.
mg/kg or 3500 mg/L or 0.35%. The
indication 'For mineral (may state the
884
BORIC ACID
A,H

Boric acid. The percentage of Boron
from Boric acid should be calculated
Boric acid
of Boron.
mg/kg or 3500 mg/L or 0.35%
885
BORNEOL

no more than 5%.
28
Schedule 1
must be no more 1%.

886
BORNYL ACETATE

fragrance.
887
BORON

When for internal use, the maximum
recommended daily dose must not
provide more than 6 mg of boron.
When for dermal use, which are not
for paediatric or antifungal use, the
concentration of boron from all
ingredients in the product must not
exceed 3500 mg/kg or 3500 mg/L or
0.35%.
888
BORON NITRIDE

in the eye.
889
BORONIA
ABSOLUTE

no more than 5%.
must be no more 1%.
890
BORONIA
MEGASTIGMA

29
Schedule 1
flavour.
no more than 5%.
891
BOSWELLIA
CARTERII
A,E,H
892
BOSWELLIA
SERRATA
A,E,H
893
BOSWELLIA
THURIFERA
A,H
894
BOTRYTIS CINEREA
A,H
895
BOVINE CALCIUM
CHONDROITIN
SULFATE
896
BOVINE POTASSIUM
CHONDROITIN
SULFATE
897
BOVINE WHEY IGRICH FRACTION

label:
- (COWMK) 'Derived from cows milk'
- (BABY3) 'Not suitable for use in
children under the age of 12 months except on the advice of a health
professional)'.
898
BRANDY
899
BRASSICA
CHINENSIS
A,H
Allyl isothiocyanate is a mandatory

component of Brassica chinensis when
the plant part is seed.
mg of allyl isothiocyanate.
30
Schedule 1
900
BRASSICA JUNCEA
A,H

component of Brassica juncea when
the plant part is seed.
901
BRASSICA NAPUS
A,E,H

component of Brassica napus when the
plant part is seed.
902
BRASSICA NIGRA
A,H

component of Brassica nigra when the
plant part is seed.
903
BRASSICA
OLERACEA VAR.
BOTRYTIS
A,E,H

component of Brassica oleracea var.
botrytis when the plant part is seed.
904
BRASSICA
OLERACEA VAR.
CAPITATA
A,E,H

capitata when the plant part is seed.
905
BRASSICA
OLERACEA VAR.
GEMMIFERA
A,H

gemmifera when the plant part is seed.
31
Schedule 1
906
BRASSICA
OLERACEA VAR.
ITALICA
A,H

component of Brassica oleracea var
italica when the plant part is seed.
907
BRASSICA
OLERACEA VAR.
VIRIDIS
A,H

viridis when the plant part is seed.
908
BRASSICA
PEKINENSIS
A,H

component of Brassica pekinensis
when the plant part is seed.
909
BRASSICA RAPA
A,E,H

component of Brassica rapa when the
plant part is seed.
910
BRAZIL NUT
911
BRILLIANT BLACK
BN

and topical use.
912
BRILLIANT BLUE
FCF

and topical use.
913
BRILLIANT BLUE
FCF ALUMINIUM
LAKE

and topical use.
914
BRILLIANT BLUE
32
Schedule 1
FCF BARIUM LAKE
and topical use.
915
BRILLIANT
SCARLET 4R

and topical use.
916
BRILLIANT
SCARLET 4R
ALUMINIUM LAKE

and topical use.
917
BRIZA MEDIA
A,H
918
BROCCOLI
919
BROMELAINS
May be derived from either the stem

or fruit of the pineapple (Ananas
comosus).
If used in a divided preparation, the
allowed units are papain units and
million papain units.
If used in an undivided preparation,
the allowed units are million papain
units per gram.
920
BROMINE

The concentration of bromine in the
preparation must be no more than
14mg/Kg or 14mg/L or 0.0014% for
oral and sublingual use.
921
BROMOSTYROL
Not for use in infants

fragrance.
922
BROMUS
CATHARTICUS
A,H
923
BROMUS INERMIS
A,H
33
Schedule 1
924
BROMUS RAMOSUS
SUBSP. RAMOSUS
A,H
925
BRONOPOL

statement:
- (BRONOP) 'Contains bronopol
926
BROUSSONETIA
PAPYRIFERA
A,H
927
BROWN FK

topical use.
928
BRUNFELSIA
UNIFLORA
A,H

929
BRUSSEL SPROUT
930
BRYONIA ALBA
A,H
931
BRYONIA DIOICA
A,H
932
BUCHU LEAF DRY
A,H
933
BUCHU LEAF OIL

no more than 5%.
must be no more 1%.
934
BUCHU LEAF
POWDER
A,E,H
935
BUCKWHEAT
E,H

34
Schedule 1
936
BUDDLEJA
OFFICINALIS
A,H
937
BULNESIA
SARMIENTI
A,E,H
938
BUNIAS ORIENTALIS
A,H
939
BUPLEURUM
FALCATUM
A,H
940
BURDOCK LEAF
DRY
A,H
941
BURDOCK LEAF
POWDER
A,H
942
BURDOCK ROOT
DRY
A,H
943
BURDOCK ROOT
POWDER
A,H
944
BUTAN-1-OL
The residual solvent limit for Butan-1ol is 50 mg per maximum

945
BUTANE
Only for use as an excipient propellant

ingredient.
946
BUTOXYETHANOL

in the eye.
947
BUTTER
948
BUTTER ACIDS

flavour.
35
Schedule 1

no more than 5%.
949
BUTTER ESTERS

flavour.
no more than 5%.
950
BUTTER STARTER
DISTILLATE

flavour.
no more than 5%.
951
BUTTERMILK DRIED
952
BUTYL 2METHYLBUTYRATE

flavour.
no more than 5%.
953
BUTYL ACETATE
The residual solvent limit for Butyl

acetate is 50 mg per maximum
954
BUTYL BUTYRATE

no more than 5%.
36
Schedule 1
must be no more 1%.

955
BUTYL BUTYRYL
LACTATE

no more than 5%.
must be no more 1%.
956
BUTYL CAPROATE

flavour.
no more than 5%.
957
BUTYL ESTER OF
PVM/MA
COPOLYMER

in the eye.
label:
- (EYE) 'Avoid contact with eyes' (or
- (EYE2) 'May be irritant to the eyes'
958
BUTYL FORMATE

flavour.
no more than 5%.
37
Schedule 1
959
BUTYL
HYDROXYBENZOAT
E

dermal application.
Medicines containing
hydroxybenzoates require the
medicine label:
- (TOTBNZ) Contains
hydroxybenzoates (or words to this
effect) if the medicine contains more
than one hydroxybenzoate source OR
Contains [insert the approved name of
hydroxybenzoate used] (or words to
this effect) if product contains one
hydroxybenzoate source.
960
BUTYL
ISOBUTYRATE

flavour.
no more than 5%.
961
BUTYL
ISOVALERATE

flavour.
no more than 5%.
962
BUTYL LACTATE

flavour.
no more than 5%.
963
BUTYL LEVULINATE E

flavour.
38
Schedule 1
no more than 5%.

964
BUTYL
METHOXYDIBENZO
YLMETHANE

sunscreens for dermal application and
The concentration in preparation must
be no more than 5%.
965
BUTYL PROPIONATE

flavour.
no more than 5%.
966
BUTYL STEARATE

dermal application.
967
BUTYL
UNDECYLENATE

no more than 5%.
must be no more 1%.
968
BUTYLATED
HYDROXYANISOLE

statement:
- (BHANIS) 'Contains butylated
hydroxyanisole' (or words to that
effect).
969
BUTYLATED
HYDROXYTOLUENE
970
BUTYLENE GLYCOL
DICAPRYLATE/DICA
PRATE

39
Schedule 1
in the eye.
971
972
BUTYLENE/ETHYLE
NE/STYRENE
COPOLYMER HYDROGENATED
BUTYLIDENE
PHTHALIDE

dermal application.
The combined concentration of
Butylene/ethylene/stryene copolymer hydrogenated and
ethylene/propylene/styrene copolymer
- hydrogenated in the medicine must
be no more than 9%.
flavour.
no more than 5%.
973
BUTYLOCTYL
SALICYLATE

in the eye.
974
BUTYLPHENYL
METHYLPROPIONAL

no more than 5%.
must be no more 1%.
975
BUTYRALDEHYDE

flavour.
40
Schedule 1

no more than 5%.
976
BUTYRIC ACID

no more than 5%.
must be no more 1%.
977
C1-8 ALKYL
TETRAHYDROXYCY
CLOHEXANOATE

in the eye.
978
C10-12
ALKANE/CYCLOALK
ANE

fragrance.
979
C10-30
CHOLESTEROL/LAN
OSTEROL ESTERS

dermal application.
980
C11-14-ISOALCOHOL C-13 RICH

fragrance.
981
C12-13 PARETH-23

41
Schedule 1
in the eye.
Residual levels of 1,4-dioxane and
ethylene oxide (and related
substances) are to be kept below the
level of detection.
982
C12-15 ALKYL
LACTATE

in the eye.
983
C12-15 ALKYL
OCTANOATE

dermal application.
984
C12-20 ACID PEG-8

ESTER

in the eye.
985
C12-20 ALKYL
GLUCOSIDE

in the eye.
986
C13-14 ISOPARAFFIN

dermal application.
987
C14-22 ALCOHOLS

in the eye.
42
Schedule 1

988
C15-19 ALKANE

in the eye.
989
C18-36 ACID
GLYCOL ESTER
Only for use topical medicines for

dermal application.
990
C18-36 ACID
TRIGLYCERIDE

dermal application.
991
C2-OCTENAL

flavour.
no more than 5%.
992
C20-40 ALCOHOLS

dermal application.
993
C20-40 ALKYL
STEARATE

in the eye.
994
C20-40 PARETH-24

in the eye.
995
C20-40 PARETH-3

43
Schedule 1
in the eye.
996
C30-45 ALKYL
CETEARYL
DIMETICONE
CROSSPOLYMER

in the eye.
997
C6-14 OLEFIN
POLYMERS HYDROGENATED

in the eye.
998
C9-11 ISOPARAFFIN

dermal application.
999
C9-11 PARETH-3

dermal application.
1000
C9-15 ALKYL
PHOSPHATE

in the eye.
must be no more than 0.12%
1001
CABBAGE
1002
CABREUVA OIL

fragrance.
1003
CADE OIL
A,E,H
44
Schedule 1
1004
CAESALPINIA
SAPPAN
A,H
1005
CAFFEINE
A,E
When used as an excipient, only for

use in topical medicines for dermal
application.
Only for use as an active ingredient for
oral use in adults when the medicine
consists principally of one or more
designated active ingredients
prescribed in Schedule 14 to the
Regulations 1990 (other than
caffeine); and contains no more than
100 mg of caffeine per maximum daily
dose.
Medicines for oral use containing
caffeine as an active ingredient require
the medicine label:
- (ADULT) 'Adults only' (or words to
that effect).
oral or sublingual and the medicine
provides a maximum recommended
daily dose of:
a) more than 1 mg but no more than
10 mg of caffeine the medicine
- (CAFFR) 'The recommended dose of
this medicine provides small amounts
of caffeine.'
b) more than 10 mg of caffeine the
label:
- (CAFF) 'Contains caffeine [state
quantity per dosage unit or per mL or
45
Schedule 1
per gram of product]'.

1006
CAJUPUT OIL
A,E,H
Cineole is a mandatory component of

Cajuput oil.
When the concentration in the
medicine is more than 25%, the
medicine is more than 25% and the
be fitted on the container.
less than 15 mL, a restricted flow
insert must be fitted to the container.
label:
- (NTAKEN) 'Not to be taken'.
When the concentration of cineole in
the preparation is more than 25%, the
not be more than 25 mL.
is more than 15 mL but no more than
25mL, the medicine must have a child
resistant closure and restricted flow
insert fitted on the container and the
46
Schedule 1

label:
is no more than 15 mL, the medicine
must have the restricted flow insert
fitted on the container and the
label:
1007
CALAMINE
A,E
Only for use as an active or excipient

ingredient for dermal application.
1008
CALCIFIED
LITHOTHAMNION
TOPHIFORME
Only for oral use.
1009
CALCIUM AMINO
ACID CHELATE
A,E,H
May only be used as a source of

calcium.
Calcium is a mandatory component of
Calcium amino acid chelate.
The concentration of Calcium in the
medicine must be no more than 25%
of the Calcium amino acid chelate in
47
Schedule 1
the formulation.
The following indications are only
oral and sublingual use:
- (OSPOR1) Source of calcium. May
assist in the prevention and/or
treatment of osteoporosis
- (OSPOR2) Source of calcium.
Women's calcium requirements are
increased after menopause. Calcium
supplementation may be of assistance
in the prevention and/or treatment of
osteoporosis
- (CALC1) Source of calcium.
increased after menopause
- (CALC2) Source of calcium. A
calcium supplement formulated to
strengthen bone and tissue in growing
and mature users. (or) Source of
calcium. A calcium supplement
formulated to strengthen bone and
tissue for children and older adults
Adequate dietary calcium in our youth
and throughout life is required to
maximise bone
- (CALC4) Source of calcium. A diet
deficient in calcium can lead to
osteoporosis in later life.
The indication For mineral (may state
the mineral) supplementation is only
1010
CALCIUM
ASCORBATE
A,E,H
Based on molecular weights the

accepted percentage of Calcium from
Calcium ascorbate is 10.3%. The
48
Schedule 1
declared quantity of Calcium from

Calcium ascorbate must be no less
than 9.8% and must be no more than
10.8% of the Calcium ascorbate in the
formulation. These figures incorporate
a 5% variance to allow for rounding in
calculations.
accepted percentage of Ascorbic acid
from Calcium ascorbate is 90.3%. The
declared quantity of Ascorbic acid
from Calcium ascorbate must be no
less than 84.9% and must be no more
than 95.3% of the Calcium ascorbate
in the medicine. These figures
incorporate a 5% variance to allow for
rounding in calculations.
osteoporosis
49
Schedule 1

maximise bone
1011
CALCIUM
ASCORBATE
DIHYDRATE
A,E,H

accepted percentage of Ascorbic acid
from Calcium ascorbate dihydrate is
82.7%. The declared quantity of
Ascorbic acid from Calcium ascorbate
dihydrate must be no less than 77.8%
and must be no more than 87.2% of
the Calcium ascorbate dihydrate in the
formulation. These figures
accepted percentage of Calcium from
Calcium ascorbate dihdrate is 9.4%.
The declared quantity of Calcium from
Calcium ascorbate dihydrate must be
no less than 8.9% and must be no
more than 9.9% of the Calcium
ascorbate dihydrate in the formulation.
These figures incorporate a 5%
variance to allow for rounding in
calculations.
50
Schedule 1

osteoporosis
maximise bone
1012
CALCIUM
ASPARTATE

Calcium aspartate and availability is
restricted to use as a source of the
relevant mineral only.
The percentage of calcium from
calcium aspartate should be calculated
calcium aspartate.
51
Schedule 1

osteoporosis
maximise bone
1013
CALCIUM
ASPARTATE
HYDROCHLORIDE
DIHYDRATE

oral medicines.
Calcium aspartate hydrochloride
dihydrate and availability is restricted
to use as a source of the relevant
52
Schedule 1
mineral only. The percentage of

calcium from calcium aspartate
hydrochloride dihydrate should be
calculated based on the molecular
weight of calcium aspartate
hydrochloride dihydrate.
oral and sublingual use: - (OSPOR1)
Source of calcium. May assist in the
prevention and/or treatment of
osteoporosis
osteoporosis
maximise bone
53
Schedule 1

1014
CALCIUM
BEHENATE
Behenic acid is a mandatory

component of Calcium behenate.
When for oral ingestion, the maximum
provide more than 383.5 mg of
Behenic acid.
1015
CALCIUM BETAHYDROXY-BETAMETHYLBUTYRATE
A,H

Calcium beta-hydroxy-betamethylbutryate must be no less than
13.9% and must be no more than
15.3% of the Calcium beta-hydroxybeta-methylbutryate in the
calculations.
osteoporosis
54
Schedule 1

maximise bone
1016
CALCIUM BETAHYDROXY-BETAMETHYLBUTYRATE
MONOHYDRATE
A,H

Calcium beta-hydroxy-betamethylbutryate monohydrate must be
more than 14.45% of the Calciumbetahydroxy-beta-methylbutryate
monohydrate in the formulation. These
figures incorporate a 5% variance to
allow for rounding in calculations.
osteoporosis
55
Schedule 1

maximise bone
1017
CALCIUM
CARBONATE
A,E,H

the medicine is intended as a mineral
supplementation, calcium is a
mandatory component of Calcium
carbonate.
calcium carbonate should be
weight of calcium carbonate.
osteoporosis
osteoporosis
increased after menopause - (CALC2)
Source of calcium. A calcium
supplement formulated to strengthen
bone and tissue in growing and mature
users. (or) Source of calcium. A
strengthen bone and tissue for children
56
Schedule 1
and older adults

maximise bone
1018
CALCIUM
CASEINATE
1019
CALCIUM
CHLORIDE
DIHYDRATE
1020
CALCIUM CITRATE
A,E,H

citrate.
calcium citrate should be calculated
calcium citrate.
57
Schedule 1
osteoporosis
maximise bone
deficient in calcium can lead
toosteoporosis in later life.
1021
CALCIUM CITRATE
TETRAHYDRATE
A,E,H
If used as an active ingredient and the

medicine is intended as a mineral
mandatory component of calcium
citrate tetrahydrate.
The amount of calcium in the active
ingredient should be calculated based
on the molecular weight of calcium
citrate tetrahydrate.
58
Schedule 1

osteoporosis
maximise bone
1022
CALCIUM
DIASPARTATE
Only for use as active ingredient in

oral medicines. Calcium is a
diaspartate and availability is restricted
mineral only.
calcium diaspartate should be
weight of calcium diaspartate.
59
Schedule 1

oral and sublingual use:- (OSPOR1)
osteoporosis
osteoporosis
increased after menopause- (CALC2)
Source of calcium. A calcium
supplement formulated to strengthen
bone and tissue in growing and mature
users. (or) Source of calcium. A
strengthen bone and tissue for children
and older adults
maximise bone
1023
CALCIUM FLUORIDE

accepted percentage of Fluoride from
Calcium fluoride is 48.7%. The
declared quantity of fluoride from
Calcium fluoride must be no less than
51.1% of the Calcium fluoride in the
60
Schedule 1

In medicines for dental use, when
containing more than 1000 mg/kg or
1000 mg/L and less than 1500 mg/kg
or 1500mg/L of fluoride ion, the
product label must comply with the
requirements of the 'Required
Advisory Statements for Medicine
Labels' (RASML). The concentration
of fluoride in the product from all
ingredients must be no more than 15
In products other than dental products,
the concentration of fluoride in the
product from all ingredients must be
no more than 15 mg/kg or 15 mg/L or
0.15%.
statements on the medicine label:
- 'Do not swallow'
- 'Do not use [this product/insert name
of product] in children 6 years of age
or less'.
1024
CALCIUM FOLINATE
A,E,H
Folinic acid is a mandatory component

of Calcium folinate.
The maximum daily dose must
provide less than 500 micrograms of
folinic acid.
When levomefolate calcium, folic
acid, folinic acid (from Calcium
folinate) and/or their derivatives are
used in combination, the medicine
provides not more than a total of 500
mcg of folic acid, folinic acid and/or
their derivatives in total per daily dose.
61
Schedule 1

osteoporosis
maximise bone
62
Schedule 1
medicine label:
balanced diet.
1025
CALCIUM
GLUCONATE
MONOHYDRATE
A,E,H

gluconate monohydrate.
calcium gluconate monohydrate
molecular weight of calcium
gluconate.
osteoporosis
63
Schedule 1

maximise bone
1026
CALCIUM
GLYCEROPHOSPHA
TE
A,E,H

glycerophosphate.
calcium glycerophosphate should be
weight of calcium glycerophosphate.
osteoporosis
64
Schedule 1

maximise bone
1027
CALCIUM
GLYCINATE

oral medicines.
Calcium glycinate and availability is
Calcium glycinate must be no less than
20.24% and no more than 22.37% of
the Calcium glycinate in the
calculations.
65
Schedule 1

osteoporosis
maximise bone
1028
CALCIUM
GLYCINATE
DIHYDRATE

Calcium glycinate dihydrate and
availability is restricted to use as a
source of the relevant mineral only.
Calcium glycinate dihydrate must be
no less than 17% and must be no more
than 18.8% of the Calcium glycinate
dihydrate in the formulation. These
66
Schedule 1

osteoporosis
maximise bone
1029
CALCIUM
HEXAFLUOROSILIC
ATE

67
Schedule 1
1030
CALCIUM
HYDROGEN
PHOSPHATE
A,E,H

calcium hydrogen phosphate.
hydrogen phosphate.
calcium hydrogen phosphate should be
weight of calcium hydrogen
phosphate.
osteoporosis
68
Schedule 1
maximise bone
1031
CALCIUM
HYDROGEN
PHOSPHATE
DIHYDRATE
A,E,H

hydrogen phosphate dihydrate.
calcium hydrogen phosphate dihydrate
molecular weight of calcium hydrogen
phosphate dihydrate.
oral and sublingual use: (OSPOR1)
osteoporosis
osteoporosis
69
Schedule 1

maximise bone
1032
CALCIUM
HYDROGEN
PHOSPHATE
MONOHYDRATE
A,E,H

hydrogen phosphate monohydrate.
Calcium Hydrogen Phosphate
Monohydrate should be calculated
Calcium Hydrogen Phosphate
Monohydrate. The following
indications are only permitted when
the medicine is for oral and sublingual
use:
osteoporosis
70
Schedule 1

maximise bone
1033
CALCIUM
HYDROXIDE
A,E,H

hydroxide. The percentage of calcium
from calcium hydroxide should be
weight of calcium hydroxide.
When used as a standard active
ingredient, can only be supplied as an
uncompounded medicine substance
packed for retail sale, and must
comply with an uncompounded
substance monograph of the British
Pharmacopeia.
71
Schedule 1

osteoporosis
maximise bone
osteoporosis in later life.'
1034
CALCIUM
HYDROXYCITRATE
A,H

hydroxycitrate. The percentage of
calcium from calcium hydroxycitrate
molecular weight of Calcium
hydroxycitrate.
72
Schedule 1

osteoporosis
maximise bone
1035
CALCIUM
HYPOPHOSPHITE

1036
CALCIUM IODIDE

73
Schedule 1
1037
CALCIUM
KETOGLUCONATE

than 1%
1038
CALCIUM LTHREONATE
Only for oral use.

Calcium L-threonate.
calcium L-threonate should be
weight of calcium L-threonate.
osteoporosis
74
Schedule 1

maximise bone
1039
CALCIUM LACTATE
A,E,H

lactate.
calcium lactate should be calculated
calcium lactate.
osteoporosis
75
Schedule 1

maximise bone
1040
CALCIUM LACTATE
GLUCONATE
A,E,H

lactate gluconate.
Calcium lactate gluconate should be
weight of Calcium lactate gluconate.
osteoporosis
76
Schedule 1

maximise bone
1041
CALCIUM LACTATE
PENTAHYDRATE
A,E,H

lactate pentahydrate.
Calcium Lactate Pentahydrate should
be calculated based on the molecular
weight of Calcium Lactate
Pentahydrate.
77
Schedule 1

osteoporosis
maximise bone
1042
CALCIUM LACTATE
TRIHYDRATE
A,E,H

preparation is intended as a mineral
lactate trihydrate.
Calcium Lactate Trihydrate should be
weight of Calcium Lactate Trihydrate.
78
Schedule 1

osteoporosis
maximise bone
1043
CALCIUM LYSINATE

oral medicines.
Calcium lysinate and availability is
79
Schedule 1
Calcium Lysinate should be calculated

Calcium Lysinate.
osteoporosis
maximise bone
1044
CALCIUM
80
Schedule 1
METHIONINATE
oral medicines.
Calcium methioninate and availability
is restricted to use as a source of the
Calcium methioninate must be no less
12.51% of the Calcium methioninate
in the formulation. These figures
osteoporosis
81
Schedule 1
maximise bone
the mineral) supplementation. is only
1045
CALCIUM OROTATE
A,E,H

orotate.
Calcium Orotate should be calculated
Calcium Orotate.
osteoporosis
82
Schedule 1

maximise bone
1046
CALCIUM OXIDE

dermal application.
1047
CALCIUM
PANTOTHENATE
A,E,H

pantothenate.
Calcium Pantothenate should be
weight of Calcium Pantothenate.
osteoporosis
83
Schedule 1

maximise bone
1048
CALCIUM
PHOSPHATE
A,E,H

the preparation is intended as a
mineral supplementation, calcium is
phosphate.
Calcium Phosphate should be
weight of Calcium Phosphate.
84
Schedule 1
osteoporosis
maximise bone
1049
CALCIUM
PHOSPHATE MONOBASIC
A,E,H

phosphate - monobasic.
calcium phosphate - monobasic should
weight of calcium phosphate -
85
Schedule 1
monobasic.
osteoporosis
maximise bone
1050
CALCIUM
PYRUVATE

86
Schedule 1

pyruvate.
calcium pyruvate should be calculated
calcium pyruvate.
osteoporosis
osteoporosis
maximise bone
87
Schedule 1

1051
CALCIUM
SACCHARATE
1052
CALCIUM SILICATE
1053
CALCIUM SODIUM
CASEINATE
A,H

label:
- (COWMK) 'Derived from cow's
milk'.
1054
CALCIUM SODIUM
LACTATE
A,E,H

sodium lactate.
calcium sodium lactate should be
weight of calcium sodium lactate.
osteoporosis
88
Schedule 1

maximise bone
1055
CALCIUM
STEARATE
1056
CALCIUM
SUCCINATE
A,E,H

succinate.
calcium succinate should be calculated
calcium succinate.
89
Schedule 1
osteoporosis
maximise bone
1057
CALCIUM SULFATE
A,E,H

sulfate.
The amount of calcium in the active
sulfate.
90
Schedule 1

osteoporosis
maximise bone
the mineral) supplementation. is only
1058
CALCIUM SULFATE DRIED
A,E,H

sulfate - dried.
calcium sulfate - dried should be
weight of calcium sulfate - dried.
91
Schedule 1

osteoporosis
maximise bone
1059
CALCIUM SULFATE
DIHYDRATE
A,E,H

sulfate dihydrate. The percentage of
calcium from calcium sulfate
dihydrate should be calculated based
92
Schedule 1

sulfate dihydrate.
osteoporosis
maximise bone
1060
CALCIUM SULFIDE

93
Schedule 1
1061
CALCIUM
THREONINATE
Only for use as an active ingredient.

Calcium threoninate and availability is
Calcium Threonite should be
weight of Calcium Threonite.
oral and sublingual use - (OSPOR1)
osteoporosis
osteoporosis
maximise bone
94
Schedule 1

1062
CALENDULA
FLOWER DRY
A,E,H
1063
CALENDULA
FLOWER POWDER
A,H
1064
CALENDULA
OFFICINALIS
A,E,H
1065
CALLERYA
RETICULATA
A,H
1066
CALLICARPA
PEDUNCULATA
A,H
1067
CALLISTEMON
CITRINUS
A,H
1068
CALLISTEPHUS
CHINENSIS
A,H
1069
CALLITRIS
INTRATROPICA

fragrance.
1070
CALLITRIS
RHOMBOIDEA
A,H
1071
CALLUNA
VULGARIS
A,E,H
1072
CALOCHORTUS
TOLMIEI
A,H
1073
CALTHA PALUSTRIS
A,H
95
Schedule 1
1074
CALUMBA ROOT
DRY
A,H
1075
CALUMBA ROOT
POWDER
A,H
1076
CALVATIA
GIGANTEA
A,E,H
1077
CALYCANTHUS
FLORIDUS
A,H
1078
CALYCANTHUS
PRAECOX
A,H
1079
CAMELLIA
JAPONICA
A,H
1080
CAMELLIA
OLEIFERA
A,E,H
If Camellia oleifera (seed oil) is used

as a solvent, it is restricted to topical
or sunscreen preparations for dermal
application only.
1081
CAMELLIA SINENSIS
A,E,H
Caffeine is a mandatory component of

Camellia sinensis for oral use.
Medicines for oral or sublingual
administration that contain caffeine as
a component of a herbal substance and
that provide a maximum
recommended daily dose of:
a) more than 1 mg but no more than 10
mg of caffeine require the following
label:
of caffeine.'
b) more than 10 mg of caffeine require
the medicine label:
96
Schedule 1
per gram of product].'

Polyphenols calculated as gallic acid
(of Camellia sinensis) is only
permitted for use as a component
when the plant part is leaf.
1082
CAMPHENE

coating solution, a flavour or a
fragrance.
no more than 5%.
must be no more 1%.
1083
CAMPHOR
E,H
In solid and semi solid preparations,

the concentration of camphor must be
no more than 12.5%.
In liquid preparations other than
essential oils, the concentration of
camphor must be no more than 2.5%.
In essential oil preparations, if the
concentration of camphor is more than
2.5% but less than or equal to 10%,
and the nominal capacity of the
container is less than 25 mL, the
medicine must have a restricted flow
insert fitted on the container and
include the following warning
10%, and the nominal capacity of the
container is more less than 15 mL, the
97
Schedule 1

container is more than 15 mL but less
than or equal to 25 mL, the medicine
must have a restricted flow insert and
child resistant closure fitted on the
container and include the following
label:
1084
1085
CAMPHOR
BENZALKONIUM
METHOSULFATE
CAMPHOR OIL
BROWN
A,H

The concentration in the preparation
Camphor, cineole and safrole are
mandatory components of Camphor
oil brown.
the concentration of Camphor must be
no more than 12.5%.
Camphor must be no more than 2.5%.
98
Schedule 1

label:
99
Schedule 1

fitted on the container and include the
medicine label:
When for internal use then the
concentration of safrole in the
medicine must be no more than 0.1%.
When for topical use then the
1086
CAMPHOR OIL
WHITE
A,E,H
Camphor and safrole are mandatory

components of Camphor oil white.
no more than 12.5%.
100
Schedule 1

label:
101
Schedule 1

1087
CAMPSIS
GRANDIFLORA
A,H
1088
CANADA BALSAM
A,H
1089
CANANGA
ODORATA
A,E,H
1090
CANANGA OIL
A,E,H
1091
CANARIUM
INDICUM
A,H
The plant part must be seed and the

plant preparation is oil.
label:
- (DERIVED) 'This product contains
material derived from nuts' (or words
to that effect).
1092
CANARIUM
LUZONICUM
A,H
1093
CANDELILLA WAX
A,E,H
1094
CANDIDA ALBICANS
1095
CANDIDA UTILIS
A,H
1096
CANINE MILK

1097
CANOLA OIL
A,E,H

component of Canola oil.


102
Schedule 1
mg of Allyl isothiocyanate.
1098
CANTHARIDES
Only available as an active

1099
CANTHAXANTHIN
Permitted as an excipient ingredient as

a colour for oral and topical use.
1100
CAPRIC ACID

no more than 5%.
must be no more 1%.
1101
CAPROIC
ALDEHYDE

no more than 5%.
must be no more 1%.
1102
CAPRYLIC
ALDEHYDE

coating solution, a flavour or a
fragrance.
no more than 5%.
must be no more 1%.
1103
CAPRYLIC/CAPRIC

103
Schedule 1
GLYCERIDES
no more than 5%.
must be no more 1%.
1104
CAPRYLIC/CAPRIC/I
SOSTEARIC/ADIPIC
TRIGLYCERIDE
1105
CAPRYLIC/CAPRIC/
MYRISTIC/STEARIC
TRIGLYCERIDE

in the eye.
The concentration in the medicine is
not to exceed 3%
1106
CAPRYLIC/CAPRIC/S
TEARIC
TRIGLYCERIDE

dermal application.
1107
CAPRYLOYL
GLYCINE

in the eye.
must not be more than 2%
1108
CAPRYLOYL
SALICYLIC ACID

must not be more than 0.3%.
1109
CAPRYLYL GLYCOL

in the eye.
104
Schedule 1

must be no more than 2%
1110
CAPRYLYL
METHICONE

in the eye.
1111
CAPSELLA BURSAPASTORIS
A,H
1112
CAPSICUM
E,H
1113
CAPSICUM ANNUUM A,E,H
1114
CAPSICUM DRY
A,E,H
1115
CAPSICUM FRUIT
OLEORESIN
A,E
1116
CAPSICUM
FRUTESCENS
A,E,H
1117
CAPSICUM POWDER
A,E,H
1118
CARALLUMA
ADSCENDENS VAR.
FIMBRIATA
The plant part must be herb and the

plant preparation must be a
hydroethanolic extract.
1119
CARAMEL

1120
CARAPICHEA
IPECACUANHA
A,H
Emetine is a mandatory component of

Carapichea ipecacuanha.

The concentration of emetine in the

Except when used in a medicine
containing only homoeopathic
preparations, a child resistant closure
must be fitted onto the container.
105
Schedule 1
1121
CARAWAY DRY
A,H
1122
CARAWAY OIL
A,E,H
1123
CARAWAY POWDER
A,H
1124
CARBOMER SODIUM

1125
CARBOMER 1342

1126
CARBOMER 2001
Only for use as an excipient ingredient

in topical medicines for dermal
application and not to be included in
medicines intended for use in the eye.
than 1% in formulations at pH 7
(approximately neutral) and 0.1% in
formulations at a different pH.
1127
CARBOMER 934

dermal application.
1128
CARBOMER 934P

dermal application.
1129
CARBOMER 940

dermal application.
1130
CARBOMER 941

1131
CARBOMER 954

1132
CARBOMER 980

1133
CARBOMER 981

1134
CARBOMER
COPOLYMER (TYPE
B)

106
Schedule 1
1135
CARBOMER
HOMOPOLYMER
(TYPE B)

1136
CARBOMER U-10

in the eye.
1137
CARBON
E,H

1138
CARBON BLACK

1139
CARBON DIOXIDE
1140
CARDAMOM FRUIT
DRY
A,H
1141
CARDAMOM FRUIT
POWDER
A,E,H
1142
CARDAMOM OIL
A,E,H
1143
CARDIOSPERMUM
HALICACABUM
A,H
1144
CARICA PAPAYA
A,E,H
1145
CARLINA ACAULIS
A,H
1146
CARMELLOSE
1147
CARMELLOSE
CALCIUM
1148
CARMELLOSE
SODIUM
1149
CARMINE

and topical use.
1150
CARMOISINE
107
Schedule 1

1151
CARMOISINE
ALUMINIUM LAKE
1152
CARNAUBA WAX
A,E,H
1153
CARNOSINE


in the eye.
1154
CAROB BEAN
EXTRACT

flavour.
no more than 5%.
1155
CAROB GUM
1156
CAROB POD
1157
CAROTENES
1158
CARPINUS BETULUS
A,H
1159
CARPINUS
CORDATA
A,H
1160
CARRAGEENAN
1161
CARROT
1162
CARROT SEED OIL
A,E,H
1163
CARTHAMUS
TINCTORIUS
A,E,H

Carthamus tinctorius (sunflower oil)

when used as a solvent is restricted to
topical or sunscreen preparations for
dermal application only.
If for oral use, the medicine requires
108
Schedule 1
the medicine label:

or likely to become pregnant' (or
1164
CARUM CARVI
A,H
1165
CARVACROL

flavour.
no more than 5%.
1166
CARVACRYL
METHYL ETHER

fragrance.
1167
CARVEOL

no more than 5%.
must be no more 1%.
1168
CARVONE

no more than 5%.
must be no more 1%.
109
Schedule 1
1169
CARVYL ACETATE

no more than 5%.
must be no more 1%.
1170
CARYA
ILLINOINENSIS
A,H
1171
CARYA OVATA
A,H
1172
CARYOPHYLLENE
OXIDE

no more than 5%.
must be no more 1%.
1173
CASCARA DRY
A,H
Hydroxyanthracene derivatives
calculated as cascaroside A is a
mandatory component of Cascara dry
when the route of administration is
oral.
label:
- (CHILD3) Use in children under 12
years is not recommended
- (LAX2) Prolonged use may cause
110
Schedule 1
serious bowel problems

- (LAX3) Do not use when abdominal
that effect)
- (S) If symptoms persist consult your
that effect).
medicine label:
- (LAX1) Drink plenty of water' (or
medicine label:
- (LAX5) This product contains
[name of the herb(s) or the chemical
component(s)]
- (LAX4) This product may have
laxative effect
label:
111
Schedule 1

that effect).
1174
CASCARA POWDER
A,H
Hydroxyanthracene derivatives
calculated as cascaroside A is a
mandatory component of Cascara
powder when the route of
administration is oral administration.
label:
that effect)
that effect).
medicine label:
112
Schedule 1

medicine label:
component(s)]
laxative effect
label:
that effect).
1175
CASCARILLA OIL
A,H
1176
CASEIN
1177
CASHEW NUT
1178
CASSIA ALATA
LEAF EXTRACT
The medicine must not contain more

than 1mg of the equivalent dry herbal
material per the maximum

in sunscreens for dermal application
113
Schedule 1
and not to be intended for use in the

eye.
The extraction ratio of the Cassia alata
can only be 1:3 in 62.5%
glycerine:water.
1179
CASSIA CINNAMON
BARK DRY
A,H
When used as an active ingredient, the

maximum daily dose of the medicine
must contain no more than 0.001% of
coumarin.
1180
CASSIA CINNAMON
BARK POWDER
A,H

coumarin.
1181
CASSIA FISTULA
A,H
Hydroxyanthracene glycosides
calculated as sennoside B is a
mandatory component of Cassia fistula
oral.
label:
114
Schedule 1
that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
115
Schedule 1
that effect).
1182
CASSIA
OCCIDENTALIS
A,H
mandatory component of Cassia
occidentalis when the route of
administration is oral administration.
label:
that effect]
that effect].
medicine label:
- (LAX1) Drink plenty of water [or
words to that effect]
medicine label:
116
Schedule 1

component(s)]
laxative effect
medicine the following warning
- (LAX1) Drink plenty of water [or
words to that effect]
that effect]
1183
CASSIA OIL
A,E,H
The concentration of Cassia oil in the

product must be no more than 2%
unless the preparation is for dermal
use as a rubefacient, in which case the
concentration of cassia oil must be no
more than 5%.
1184
CASSIE ABSOLUTE

no more than 5%.
must be no more 1%.
117
Schedule 1
1185
CASTANEA
MOLLISSIMA
A,H
1186
CASTANEA SATIVA
A,H
1187
CASTOR OIL
A,E
1188
CASTOR OIL ETHOXYLATED

HYDROGENATED
1189
CASTOR OIL HYDROGENATED
A,E

1190
CASTOR OIL SULFATED

dermal application.
1191
CASTOREUM
Only permitted for use as an active

1192
CASUARINA
EQUISITIFOLIA
A,H
1193
CATALPA
BIGNONIOIDES
A,H
1194
CATALPA OVATA
A,H
1195
CATECHU
A,H
1196
CATHARANTHUS
ROSEUS
A,H
Vinblastine, vincamine, vincristine,

vindesine, vinorelbine and yohimbine
are mandatory components of
Cantharanthus roseus.
The concentration of vinblastine,
vincamine, vincristine, vindesine,
vinorelbine and yohimbine in the
10mg/kg or 10 mg/L or 0.001%.
118
Schedule 1
1197
CAULIFLOWER
1198
CAULOPHYLLUM
THALICTROIDES
A,E,H
1199
CAUSTICUM
1200
CEANOTHUS
AMERICANUS
A,H
1201
CEDAR LEAF OIL
A,E,H
1202
CEDARWOOD OIL


no more than 5%.
must be no more 1%.
1203
CEDARWOOD OIL
ATLAS

fragrance.
1204
CEDARWOOD OIL
TERPENES

no more than 5%.
must be no more 1%.
1205
CEDARWOOD OIL
VIRGINIA

119
Schedule 1
fragrance.
1206
CEDRENOL

fragrance.
1207
CEDRENYLACETAT
E

fragrance.
1208
CEDROL

fragrance.
1209
CEDRUS
ATLANTICA
A,E,H
1210
CEDRUS DEODARA
A,H
1211
CEDRUS LIBANI

1212
CEDRYL ACETATE

fragrance.
1213
CEDRYL METHYL
120
Schedule 1
ETHER

fragrance.
1214
CELERY LEAF
E,H
1215
CELERY SEED DRY
A,E,H
1216
CELERY SEED OIL
A,E,H
1217
CELERY SEED
POWDER
A,H
1218
CELLACEFATE
1219
CELLULASE
Must be derived from Trichoderma

longibrachiatum only.
If used as an undivided preparation,
the allowed unit is Cellulase unit per
gram or Thousand cellulase unit per
gram.
If used as an divided preparation, the
allowed unit is Thousand cellulase unit
or cellulase unit.
1220
CELLULOSE

flavour.
no more than 5%.
1221
CELLULOSE DISPERSIBLE
1222
CELLULOSE MICROCRYSTALLIN
E
1223
CELLULOSE POWDERED
121
Schedule 1
1224
CELOSIA ARGENTEA A,H
1225
CELOSIA ARGENTEA A,H

L. VAR. CRISTATA
1226
CENTAUREA
CYANUS
A,E,H
1227
CENTAURIUM
ERYTHRAEA
A,H
1228
CENTELLA
ASIATICA
A,E,H
1229
CENTELLA
ASIATICA
MERISTEM CELL
CULTURE

medicines intended for use in the eye
or on damaged skin.
1230
CENTIPEDA
CUNNINGHAMII
A,E,H
1231
CENTIPEDA MINIMA
A,H
1232
CEPHALANOPSIS
SEGETUM
A,H
1233
CERAMIDE 1

dermal application.
1234
CERAMIDE 2

for use in the eye.
1235
CERAMIDE 3
1236
CERATONIA
SILIQUA
A,E,H

dermal application.
122
Schedule 1
1237
CERATOSTIGMA
WILLMOTTIANUM
A,H
1238
CERESIN

dermal application.
1239
CESTRUM
LATIFOLIUM

The plant part must be leaf and must
be a water extract.
than 0.5%.
1240
CETEARETH-12

dermal application.
1241
CETEARETH-2

dermal application.
1242
CETEARETH-20

dermal application.
1243
CETEARETH-25

dermal application.
1244
CETEARETH-30

dermal application.
1245
CETEARETH-33

for dermal application and not to be
in the eye.
Residual levels of 1,4-dioxane oxide
(and related substances) are to be kept
below the level of detection.
1246
CETEARYL
GLUCOSIDE

dermal application.
123
Schedule 1
1247
CETEARYL
ISONONANOATE

dermal application.
1248
CETEARYL
OCTANOATE

dermal application.
1249
CETETH-10

dermal application.
1250
CETETH-2

dermal application.
1251
CETETH-24

dermal application.
1252
CETETH-5

dermal application.
1253
CETOMACROGOL
1000

dermal application.
1254
CETOMACROGOL
1000 PHOSPHATE

1255
CETOMACROGOL
500 PHOSPHATE

1256
CETOSTEARYL
ALCOHOL
1257
CETOSTEARYL
ALCOHOL/COCOGLUCOSIDE
COMPLEX

must be no more than 5.0 %
124
Schedule 1
1258
CETRARIA
ISLANDICA
A,H
1259
CETRIMONIUM
BROMIDE

dermal application.
1260
CETRIMONIUM
CHLORIDE

dermal application.
1261
CETYL-PG
HYDROXYETHYL
PALMITAMIDE

in the eye.
1262
CETYL ACETATE

dermal application.
1263
CETYL ALCOHOL

dermal application.
1264
CETYL
DIMETHICONE
COPOLYOL

dermal application.
1265
CETYL DIMETICONE

dermal application.
1266
CETYL
DIMETICONE/BISVINYLDIMETICONE
CROSSPOLYMER

1267
CETYL ESTERS WAX

dermal application.
1268
CETYL
HYDROXYETHYLCE
LLULOSE

in the eye.
125
Schedule 1

1269
CETYL LACTATE

dermal application.
1270
CETYL OCTANOATE

dermal application.
1271
CETYL PALMITATE

dermal application.
1272
CETYL PHOSPHATE

dermal application.
1273
CETYLPYRIDINIUM
CHLORIDE

dermal application.
Medicines for topical use must include
the name of any antimicrobial
preservative in the goods.
1274
CHAENOMELES
LAGENARIA
A,H
1275
CHAENOMELES
SPECIOSA
A,H
1276
CHAETOMIUM
INDICUM
A,H
1277
CHALK
A,E
1278
CHAMAECYPARIS
LAWSONIANA
A,H
1279
CHAMAELIRIUM
LUTEUM
A,H
1280
CHAMAEMELUM
NOBILE
A,E,H
1281
CHAMOMILE
A,E,H

126
Schedule 1
FLOWER DRY
1282
CHAMOMILE OIL
ENGLISH
A,E,H
1283
CHAMOMILE OIL
GERMAN
A,E,H
1284
CHANGIUM
SMYRNIOIDES
A,H
1285
CHARCOAL ACTIVATED
A,E,H
When for internal use, the medicine

- (ACCOAL) 'Products containing
activated charcoal should be used with
caution in children since it may
interfere with absorption of nutrients.
Activated charcoal may interact with
other medicines. Activated charcoal is
not recommended for long-term use'
1286
CHEIRANTHUS
CHEIRI
A,H
1287
CHELIDONIUM
MAJUS
A,E,H
When for oral or sublingual use, the

label:
- (CELAND) 'WARNING: Greater
Celandine may harm the liver in some
people. Use only under the
supervision of a healthcare
professional'.
1288
CHELONE GLABRA
A,H
1289
CHENOPODIUM
ALBUM
A,H
1290
CHENOPODIUM
VULVARIA
A,H
127
Schedule 1
1291
CHERRY
1292
CHERRY
DISTILLATE

flavour.
no more than 5%.
1293
CHESTNUT SWEET
E,H
1294
CHICKEN POWDER BLACK BONED
1295
CHILLI
E,H
1296
CHIMAPHILA
UMBELLATA
A,H
1297
CHIONANTHUS
VIRGINICA
A,H
1298
CHLORELLA

Chlorella.
1299
CHLORELLA
PYRENOIDOSA
1300
CHLORELLA
VULGARIS
A,E

Chlorella vulgaris.
128
Schedule 1

1301
CHLORHEXIDINE
ACETATE

dermal application.
1302
CHLORHEXIDINE
GLUCONATE

dermal application.
1303
CHLOROACETAMID
E

dermal application.
1304
CHLOROBUTANOL
HEMIHYDRATE
Only for use in topical preparations for

localised effect.
label:
- (CHLORB) 'Contains chlorbutol' (or
1305
CHLOROCRESOL

dermal application.
label:
- (CHLCRS) 'Contains chlorocresol
129
Schedule 1
[quantity]' (or words to that effect)

1306
CHLOROFORM
The residual solvent limit must be no

more than 0.6 mg per recommended
daily dose and the concentration in the
0.006%.
1307
CHLOROPHYLL
A,E
Only for use as a colour in oral and

topical medicines.
1308
CHLOROPHYLLCOPPER
COMPLEXES

topical medicines.
1309
CHLOROPHYLLINCOPPER COMPLEX

topical medicines.
1310
CHLOROPHYLLINCOPPER COMPLEX
ALUMINIUM LAKE
Only for as a colour in oral and topical

medicines.
1311
CHLOROXYLENOL

dermal application.
1312
CHLORPHENESIN

dermal application.
1313
CHOCOLATE
BROWN HT

and topical use.
1314
CHOLESTEROL
E,H

homoeopathic medicines or an
excipient ingredient in topical
preparations.
1315
CHOLESTERYL
HYDROXYSTEARAT
E

dermal application.
1316
CHOLESTERYL
MACADAMIATE

dermal application.
1317
CHOLESTERYL/BEH
ENYL/OCTYLDODEC
YL LAUROYL

130
Schedule 1
GLUTAMATE
in the eye.
1318
CHOLETH-24

dermal application.
1319
CHOLINE
BITARTRATE
A,E
1320
CHOLINE
DIHYDROGEN
CITRATE
1321
CHONDRODENDRON
TOMENTOSUM
A,H

Chondrodendron tomentosum in the
product must be no more than
10mg/Kg or 10mg/L or 0.001%.
1322
CHONDROITIN
SULFATE - BOVINE
1323
CHONDROITIN
SULFATE - BOVINE
SODIUM
1324
CHONDROITIN
SULFATE - SHARK
1325
CHONDROITIN
SULFATE - SHARK
SODIUM
1326
CHONDRUS CRISPUS
A,E,H

Chondrus crispus.
131
Schedule 1

1327
CHONDRUS DRY
A,E,H

Chondrus dry.
1328
CHONDRUS
EXTRACT
A,E,H

Chondrus extract.
1329
CHROMIC
CHLORIDE
HEXAHYDRATE
A,H
If used as an active ingredient in a

preparation for mineral
supplementation, chromium is a
mandatory component of chromic
chloride hexahydrate.
132
Schedule 1
The amount of chromium in the active

on the molecular weight of chromic
dose must provide 50 micrograms or
less of chromium from organic sources
(i.e.: chromium picolinate, chromium
nicotinate and yeast - high chromium).
1330
CHROMIUM
NICOTINATE
Chromium is a mandatory component

of Chromium nicotinate.
micrograms of chromium from organic
sources. Chromium Nicotinate is
considered to be an organic form of
chromium.
oral and sublingual use.
1331
CHROMIUM
PICOLINATE

of Chromium picolinate.
micrograms of chromium from organic
sources. Chromium picolinate is
considered to be an organic form of
chromium.
133
Schedule 1
1332
CHRYSANTHEMUM
BALSAMITA
A,H
1333
CHRYSANTHEMUM
INDICUM
A,H
1334
CHRYSANTHEMUM
LEUCANTHEMUM
A,H
1335
CHRYSANTHEMUM
MARSHALLII
A,H
1336
CHRYSANTHEMUM
SINENSE
A,H
1337
CHRYSOPOGON
ZIZANIOIDES
A,E,H
1338
CHRYSOSPORIUM
PRUINOSUM
A,H
1339
CIBOTIUM
BAROMETZ
A,H
1340
CICHORIUM
INTYBUS
A,E,H
1341
CICUTA VIROSA
A,H

dose must be no more than the
equivalent of 1mg of the dry herbal
material.
1342
CINCHONA BARK
DRY
A,H
Quinidine and quinine are mandatory

components of Cinchona bark dry.
The medicine must contain no more
than 50 micrograms of quinine and no
more than 10 micrograms
concentration of quinidine per g or
mL.
1343
CINCHONA BARK
POWDER
A,H

components of Cinchona bark powder.
134
Schedule 1

mL.
1344
CINCHONA
OFFICINALIS
A,H

components of Cinchona officinalis.
mL.
1345
CINCHONA
PUBESCENS
A,H

components of Cinchona pubescens.
mL.
1346
CINEOLE
A,E
Permitted for use only as an active

ingredient in medicated space sprays
insert fitted on the container and the
label:
- (CHILD) Keep out of reach of
- (NTAKEN) Not to be taken
135
Schedule 1

label:
1347
CINNAMALDEHYDE

no more than 5%.
must be no more 1%.
1348
CINNAMIC ACID

no more than 5%.
must be no more 1%.
1349
CINNAMOMUM
CAMPHORA
A,E,H
Camphor, cineole, safrole and thujone

Cinnamomum camphora.
no more than 12.5%.
136
Schedule 1

children' (or words to that effect)
container and requires the following
label:
137
Schedule 1

fitted on the container and requires the
medicine label:
coumarin.
1350
CINNAMOMUM
A,E
Cassia oil is a mandatory component

of Cinnamomum cassia if the plant
138
Schedule 1
CASSIA
preparation is an essential oil, fixed oil

or infused oil.
The concentration of Cassia oil in the
coumarin.
1351
CINNAMOMUM
VERUM
A,E,H
Cinnamon bark oil is a mandatory

component of Cinnamomum verum
when the plant part is bark and the
plant preparation is essential oil, fixed
oil or infused oil.
The concentration of cinnamon bark
oil in the medicine must be no more
than 2%.
Cinnamon leaf oil is a mandatory
component of Cinnamomum verum
when the plant part is leaf.
When the concentration of cinnamon
leaf oil in the preparation is more than
container must be no more than than
25 mL.
container is more than 15 mL but no
more than 25mL, the medicine must
have a child resistant closure and
label:
139
Schedule 1

container is no more than 15 mL, the
container must be fitted with a
restricted flow insert and requires the
medicine label:
coumarin.
1352
CINNAMON BARK
OIL
A,E,H
The concentration of Cinnamon bark

oil in the product must be no more
than 2%.
must contain no more than 0.001%
Coumarin.
1353
CINNAMON DRY
A,H

component of Cinnamon dry.
than 2%.
Coumarin.
1354
CINNAMON LEAF
OIL
A,E,H

container must not be more than 25
mL.
140
Schedule 1

more than 25mL, the medicine must
label:
container is no more than 15 mL , the
container must be fitted with a
restricted flow insert and requires the
medicine label:
Coumarin.
1355
CINNAMON
POWDER
A,E,H

component of Cinnamon powder.
than 2%.
must contain no more than 0.001%
Coumarin.
141
Schedule 1
1356
CINNAMYL
ACETATE

no more than 5%.
must be no more 1%.
1357
CINNAMYL
ALCOHOL

no more than 5%.
must be no more 1%.
1358
CINNAMYL
BUTYRATE

flavour.
no more than 5%.
1359
CINNAMYL
CINNAMATE

flavour.
no more than 5%.
1360
CINNAMYL
FORMATE

flavour.
142
Schedule 1
no more than 5%.

1361
CINNAMYL
ISOBUTYRATE

flavour.
no more than 5%.
1362
CINNAMYL
ISOVALERATE

flavour.
no more than 5%.
1363
CINNAMYL
PROPIONATE

fragrance.
1364
CINOXATE

sunscreens for dermal application
only.
The concentration of the ingredient
must be no more than 6% and must not
be used in topical products intended
for use in the eye.
1365
CIS-2-METHYL-4PROPYL-1,3OXATHIANE

no more than 5%.
must be no more 1%.
143
Schedule 1
1366
CIS-3-HEXEN-1-OL

must be no more 1%.
1367
CIS-3-HEXENAL

flavour.
no more than 5%.
1368
CIS-3-HEXENYL 2METHYLBUTYRATE

flavour.
no more than 5%.
1369
CIS-3-HEXENYL
ACETATE

no more than 5%.
must be no more 1%.
1370
CIS-3-HEXENYL
BENZOATE

fragrance.
144
Schedule 1

1371
CIS-3-HEXENYL
BUTYRATE

no more than 5%.
must be no more 1%.
1372
CIS-3-HEXENYL
FORMATE

flavour.
no more than 5%.
1373
CIS-3-HEXENYL
HEXANOATE

flavour.
no more than 5%.
1374
CIS-3-HEXENYL
ISOBUTYRATE

fragrance.
1375
CIS-3-HEXENYL
ISOVALERATE

no more than 5%.
145
Schedule 1

must be no more 1%.
1376
CIS-3-HEXENYL
LACTATE

flavour.
no more than 5%.
1377
CIS-3-HEXENYL
METHYL
CARBONATE

fragrance.
1378
CIS-3-HEXENYL
SALICYLATE

fragrance.
1379
CIS-4-HEPTENAL

flavour.
no more than 5%.
1380
CIS-6-NONEN-1-AL

no more than 5%.
must be no more 1%.
146
Schedule 1
1381
CIS-6-NONENOL

no more than 5%.
must be no more 1%.
1382
CIS-BETA-OCIMENE

fragrance.
1383
CISHEXAHYDROCUMIN
YL ALCOHOL

fragrance.
1384
CIS-JASMONE

no more than 5%.
must be no more 1%.
1385
CISTANCHE
DESERTICOLA
A,H

only.
147
Schedule 1
for use in the eye.

1386
CISTANCHE SALSA
A,H

only.
for use in the eye.
1387
CISTUS
LADANIFERUS
A,E,H
1388
CITRAL
1389
CITRAL DIETHYL
ACETAL

fragrance.
1390
CITRAL DIMETHYL
ACETAL

fragrance.
1391
CITRIC ACID
A,E
1392
CITRIC ACID
DIHYDRATE
A,E
1393
CITRIC ACID
MONOHYDRATE
A,E
Where intended for topical use,

sponsors should consider the impact of
excipients on the sensitivity of the skin
to sunlight and should ensure the
finished product is safe for its intended
purpose.
Where intended for topical use,

sponsors should consider the impact of
excipients on the sensitivity of the skin
to sunlight and should ensure the
148
Schedule 1
purpose.
1394
CITRIC AND FATTY

ACID ESTERS OF
GLYCEROL

flavour.
no more than 5%.
1395
CITROL

flavour.
no more than 5%.
1396
CITRON
1397
CITRONELLA OIL
A,E,H
Medicines for topical use containing

citronella oil require the following
label:
- (CITRON) 'Contains citronella oil'.
1398
CITRONELLA
TERPENES

fragrance.
1399
CITRONELLAL

no more than 5%.
must be no more 1%.
149
Schedule 1
1400
CITRONELLIC ACID

no more than 5%.
must be no more 1%.
1401
CITRONELLOL

dermal application.
1402
CITRONELLYL
ACETATE

no more than 5%.
must be no more 1%.
1403
CITRONELLYL
BUTYRATE

flavour.
no more than 5%.
1404
CITRONELLYL
FORMATE

no more than 5%.
must be no more 1%.
150
Schedule 1
1405
CITRONELLYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
1406
CITRONELLYL
NITRILE

fragrance.
1407
CITRONELLYL
OXYACETALDEHYD
E

fragrance.
1408
CITRONELLYL
PROPIONATE

no more than 5%.
must be no more 1%.
1409
CITRONELLYL
TIGLATE

fragrance.
151
Schedule 1

1410
CITRONNOL

flavour.
no more than 5%.
1411
CITRULLUS
COLOCYNTHIS

When for oral use, the concentration
of Citrullus colocynthis must be more
than 4X (i.e. 1X 2X 3X).
1412
CITRULLUS
VULGARIS
A,H
1413
CITRUS
AURANTIFOLIA
A,E,H
1414
CITRUS
AURANTIUM
A,E,H
Oxedrine is a mandatory component of

Citrus aurantium when intended for
internal use.
The quantity of Oxedrine in the
recommended daily dose of the
medicine must be no more than 30 mg.
1415
CITRUS
BIOFLAVONOIDS
EXTRACT
A,E,H
1416
CITRUS
CHACHIENSIS
A,H
1417
CITRUS EXTRACT

flavour.
no more than 5%.
1418
CITRUS FIBRE
152
Schedule 1
1419
CITRUS LIMETTA
A,H
1420
CITRUS LIMON
A,E,H

Citrus limon when intended for
internal use.
The quantity of oxedrine in the
recommended daily dose of the
medicine must be no more than 30 mg.
1421
CITRUS MAXIMA
A,H
1422
CITRUS MEDICA
A,E,H
1423
CITRUS OIL
DISTILLED

fragrance.
1424
CITRUS
RETICULATA
A,E,H

Citrus reticulata when intended for
internal use.
more than 30 mg.
1425
CITRUS SINENSIS
A,E,H

Citrus sinensis when intended for
internal use.
more than 30 mg.
1426
CITRUS SINENSIS
PEEL MOLASSES
EXTRACT

flavour.
no more than 5%.
1427
CITRUS UNSHIU
A,E,H
153
Schedule 1
Citrus unshiu when intended for

internal use.
more than 30 mg.
1428
CITRUS X PARADISI
A,E,H
1429
CITRUS X WILSONII
A,H
1430
CIVET

fragrance.
1431
CIVET ABSOLUTE

fragrance.
1432
CIVET SYNTHETIC

fragrance.
1433
CIVETONE

fragrance.
1434
CLARY OIL
A,E,H
1435
CLAVICEPS
PURPUREA
A,H

Claviceps purpurea must be no more
154
Schedule 1
than 10mg/Kg or 10mg/L or 0.001%.

1436
CLEMATIS
ARMANDII
A,H
1437
CLEMATIS
CHINENSIS
A,E,H
1438
CLEMATIS RECTA
A,H
1439
CLEMATIS VITALBA
A,H
1440
CLERODENDRUM
TRICHOTOMUM
A,H
1441
CLINOPODION
POLYCEPHALUM
A,H
1442
CLINOPODIUM
NEPETA SUBSP.
GLANDULOSUM
A,H
1443
CLIVER HERB DRY
A,H
1444
CLIVER HERB
POWDER
A,H
1445
CLOVE BUD OIL
A,E,H
When the concentration of Clove Bud

Oil in the preparation is more than
container must be no more than 25
mL.
When the concentration of Clove Bud
container is more 15 mL but no more
than 25mL, a child resistant closure
medicine label:
155
Schedule 1
When the concentration of clove bud

oil in the preparation is more than 25%
container is more than 15 mL , a
restricted flow insert must be fitted on
the container and requires the
medicine label:
1446
CLOVE DRY
A,E,H
1447
CLOVE LEAF OIL
A,E,H
When the concentration of Clove Leaf

mL.
When the concentration of Clove Leaf
medicine label:
When the concentration of clove leaf
container is more than 15 mL, a
medicine label:
156
Schedule 1

1448
CLOVE OIL
TERPENES

flavour.
no more than 5%.
1449
CLOVE POWDER
A,E,H
1450
CLOVE STEM OIL
A,E,H
When the concentration of Clove Stem

mL.
fitted on the container requires the
medicine label:
container is more than 15 mL , a
medicine label:
157
Schedule 1

1451
CLUPEA HARENGUS
LIPID EXTRACT
1452
CNICUS
BENEDICTUS
A,H
1453
CNICUS JAPONICUS
A,H
1454
CNIDIUM MONNIERI
A,H
1455
CNIDIUM
OFFICINALE
A,H
1456
COBALTOUS
NITRATE
HEXAHYDRATE

1457
COCAMIDE DEA

dermal application.
1458
COCAMIDE MEA

dermal application.
1459
COCAMIDOPROPYL
BETAINAMIDE MEA
CHLORIDE

included in topical products intended
for use in the eye.

mg EPA, DHA and DPA combined,
when used alone or in combination
with other sources of omega-3 fatty
acids.

1460
COCAMIDOPROPYL
BETAINE
Only for topical, mucous membrane

(buccal mucosa) and dental use and
not to be included in topical medicines
158
Schedule 1
must be:
a) no more than 1% in leave on
medicines
b) no more than 15% in wash on /wash
off medicines
c) 1.2% for buccal mucosa and dental
medicines.
Levels of impurities 3dimethylaminopropylamine (DMAPA)
and amidoamine
(dimethylaminopropylcocoamide; AA)
must be controlled to below the level
of detection.
1461
COCCOLOBIA
UVIFERA
A,H
1462
COCCULUS
SARMENTOSUS
A,H
1463
COCHINEAL
E,H

Permitted for use as a colour
ingredient for oral and topical use.
1464
COCHLEARIA
OFFICINALIS
A,H
1465
COCHLIOBOLUS
HETEROSTROPHUS
A,H
1466
COCILLANA DRY
A,H
1467
COCILLANA
POWDER
A,H
1468
COCO-BETAINE

dermal application.
1469
COCO-CAPRYLATE

159
Schedule 1
in the eye.
The concentration is to be no more
than 12.5% in the medicine.
1470
COCO-GLUCOSIDE

in the eye.
1471
COCOOCTANOATE/DECAN
OATE

in the eye.
1472
COCOA EXTRACT

flavour.
no more than 5%.
1473
COCOA POWDER
A,E,H
1474
COCOGLYCERIDES
1475
COCONUT
1476
COCONUT ACID
1477
COCONUT OIL
A,E,H
1478
COCONUT OIL FRACTIONATED
1479
COCONUT OIL HYDROGENATED
1480
COCOS NUCIFERA
A,E,H
1481
COD-LIVER OIL
A,E

dermal application.
Vitamin A and colecalciferol are

mandatory components of Cod-liver
160
Schedule 1
oil.
When for use in topical medicines, the
concentration of Vitamin A in the
daily dose must be no more than 3000
micrograms of Retinol Equivalents.
Divided preparations for internal use
must contain more than 33
micrograms of Retinol Equivalents per
dosage unit and no more than 3000
micrograms of Retinol Equivalents of
Vitamin A in the maximum daily dose.
Undivided preparations for internal
use must contain more than 33
micrograms Retinol Equivalents per
gram of vitamin A and no more than
3000 micrograms of Retinol
Equivalents of Vitamin A in the
maximum daily dose.
When for use in adults the medicine
- (VITA2) WARNING: If you are
pregnant - or considering becoming
pregnant - do not take vitamin A
supplements without consulting your
doctor or pharmacist [or words to that
effect]. NOTE: Position this warning
at the beginning of the directions for
use.
- (VITA4) WARNING - When taken
in excess of 3000 micrograms retinol
equivalents - vitamin A can cause birth
defects. NOTE: Position this warning
use.
- (VITA3) The recommended daily
161
Schedule 1
amount of vitamin A from all sources

is 700 micrograms retinol equivalents
for women and 900 micrograms
retinol equivalents for men.
more than 25 micrograms of vitaminD.
medicine label:
balanced diet.
The indication Vitamin D helps
calcium absorption (or words of like
intent) and A diet deficient in
calcium can lead to osteoporosis in
later life are permitted only for oral
use.
1482
CODONOPSIS
LANCEOLATA
A,H
1483
CODONOPSIS
PILOSULA
A,H
1484
CODONOPSIS
TANGSHEN
A,H
1485
COFFEA ARABICA
A,E,H

Coffea arabica.
daily dose of:
162
Schedule 1

of caffeine.'
label:
1486
COFFEA
CANEPHORA
A,E,H

Coffea canephora.
daily dose of:
of caffeine.'
label:
1487
COFFEE
E,H

coffee.
163
Schedule 1

daily dose of:
of caffeine.'
label:
1488
COFFEE OIL

flavour.
no more than 5%.
1489
COFFEE SOLID
EXTRACT

flavour.
no more than 5%.
1490
COGNAC OIL

flavour.
no more than 5%.
1491
COGNAC OIL GREEN
A,E,H
164
Schedule 1
1492
COGNAC OIL WHITE

flavour.
no more than 5%.
1493
COIX LACHRYMAJOBI
A,H
1494
COLA ACUMINATA
A,E,H

Cola acuminata.
daily dose of:
requires the warning statement:
of caffeine.'
medicine requires the warning
statement:
1495
COLA COTYLEDON
DRY
A,H

Cola cotyledon dry.
daily dose of:
165
Schedule 1

of caffeine.'
statement:
1496
COLA COTYLEDON
POWDER
A,H

Cola cotyledon powder.
daily dose of:
of caffeine.'
statement:
1497
COLA NITIDA
A,E,H

Cola nitida.
daily dose of:
166
Schedule 1

of caffeine.'
statement:
1498
COLCHICUM
AUTUMNALE

1499
COLECALCIFEROL
A,E

recommended daily dose must not be
more than 25 micrograms of Vitamin
D.
medicine label: (VIT) 'vitamins can only be of
assistance if the dietary intake is
inadequate.' OR 'Vitamin supplements
should not replace a balanced diet.'
The indication 'Vitamin D helps
calcium absorption (or words to that
intent) and a diet deficient in calcium
can lead to osteoporosis in later life' is
permitted only for oral use.
1500
COLEUS
FORSKOHLII
A,E,H
1501
COLLAGEN
1502
COLLAGEN -
167
Schedule 1
HYDROLYSED
1503
COLLINSONIA
CANADENSIS
A,H
1504
COLOPHONY
A,E,H
1505
COLOSTRUM
POWDER - BOVINE

statement:
- (BOVCOL) 'Products containing
bovine colostrum powder contain
lactose and cow's milk proteins (or
words to that effect). This product is
not suitable for use in children under
the age of 12 months except on
professional health advice.'
1506
COMMIPHORA
HABESSINICA
A,H
1507
COMMIPHORA
KATAF
A,H
1508
COMMIPHORA
MYRRHA
A,E,H
1509
COMMON INDIAN
COBRA

1510
CONCENTRATED
OMEGA-3
TRIGLYCERIDES FISH
Only for oral use.
1511
CONCENTRATED
OMEGA-3
TRIGLYCERIDES SQUID
Only for oral use.

'Concentrated omega-3-triglycerides squid' must be obtained from species
of the order Teuthida of the class
Cephalopoda AND be in combination
with other ingredients in the
preparation AND be presented in a
therapeutic dosage form for
therapeutic use.
168
Schedule 1

label:
- (SFOOD) 'Derived from seafood'.
1512
CONIFER GREEN
NEEDLE COMPLEX
1513
CONIOSELIUM
UNIVITTATUM
A,H
1514
CONIUM
MACULATUM
Only for topical and oral use. Must be

made by petroleum ether extraction of
needles of the conifer species Pinus
sylvestris (Scotch Pine) and Picea
abies (Norwegian Spruce).

than exceed 12X homoeopathic
dilution.
1515
CONVALLARIA
MAJALIS
A,H
1516
CONYZA
CANADENSIS
A,H
1517
COPAIBA OIL
A,E,H
1518
COPAIFERA
LANGSDORFFII
A,E,H
1519
COPERNICIA
CERIFERA
A,E,H
1520
COPOVIDONE
1521
COPPER

Convallaria majalis in the product
must be no more than 10mg/Kg or
10mg/L or 0.001%.

When for internal use the maximum
daily dose must not contain more than
5 mg of copper.
When for other than internal use, the
concentration of copper compounds
169
Schedule 1

1522
COPPER (II)
ASPARTATE
A,H
Copper is a mandatory component of

copper (II) aspartate.
The percentage of copper from copper
(II) aspartate should be calculated
Copper (II) aspartate.
The concentration of copper
compounds in products must be no
more than 5%. The maximum daily
dose must not contain more than 5mg
of copper.
1523
COPPER (II)
GLYCINATE
A,H

copper (II) glycinate.
(II) glycinate should be calculated
Copper (II) glycinate.
of copper.
1524
COPPER (II)
LYSINATE
A,H

copper (II) lysinate.
(II) lysinate should be calculated based
on the molecular weight of Copper (II)
170
Schedule 1
lysinate.
of copper.
1525
COPPER ACETYL
TYROSINATE
METHYLSILANOL

dermal application.
1526
COPPER
CHLOROPHYLL

fragrance.
1527
COPPER
CHLOROPHYLLIN

topical medicines.
1528
COPPER
GLUCONATE
A,E

copper gluconate.
gluconate should be calculated based
on the molecular weight of copper
gluconate.
5 mg of copper.
171
Schedule 1

1529
COPPER
TRIPEPTIDE-1

dermal application.
1530
COPTIS CHINENSIS
A,H
1531
COPTIS JAPONICA
A,H
1532
CORAL - RED

1533
CORALLINA
OFFICINALIS

in the eye.
The concentration in the medicine is to
be no more than 1%.
1534
CORDYCEPS
SINENSIS
A,E,H
1535
CORIANDER DRY
A,H
1536
CORIANDER OIL
A,E,H
1537
CORIANDER
POWDER
A,H
1538
CORIANDRUM
SATIVUM
A,E,H
1539
CORN GLYCERIDES
1540
CORN SILK DRY
A,H
1541
CORN SILK POWDER
A,H
1542
CORN SYRUP
Must not contain material of animal

origin such as insect larvae.

flavour.
172
Schedule 1
no more than 5%.

1543
CORN SYRUP
SOLIDS

flavour.
no more than 5%.
1544
CORNUS FLORIDA
A,H
1545
CORNUS
OFFICINALIS
A,H
1546
CORTISONE
ACETATE
1547
CORYDALIS
AMBIGUA
A,E,H
1548
CORYDALIS
BUNGEANA
A,H
1549
CORYDALIS CAVA
A,H
1550
CORYDALIS
FABACEA
A,H
1551
CORYDALIS
FORMOSA
A,H
1552
CORYDALIS
TURTSCHANINOVII
A,H
1553
CORYLUS
AMERICANA
A,H
1554
CORYLUS
AVELLANA
A,H
1555
CORYMBIA
CITRIODORA
A,E,H
Only available as an active


Corymbia citriodora.
When the plant preparation is oil and
the concentration of the oil in the
preparation is more than 25%, the
173
Schedule 1
be no more than than 25 mL.

25mL, a child resistant closure and
medicine label:
is no more than 15 mL, the container
must be fitted with a restricted flow
insert and requires the following
label:
1556
CORYMBIA
FICIFOLIA
A,H

Corymbia ficicolia.
the concentration of the oil in the
174
Schedule 1

medicine label:
is no more than 15 mL, the container
must be fitted with a restricted flow
insert and requires the following
label:
1557
COSMOS
BIPINNATUS
A,H
1558
COSTUS ROOT OIL
A,H
1559
COSTUS SPICATUS
A,H
1560
COTTONSEED OIL
A,E,H
1561
COTTONSEED OIL HYDROGENATED
1562
COUCH GRASS
RHIZOME DRY
A,H
1563
COUCH GRASS
RHIZOME POWDER
A,H
1564
COUMARIN

175
Schedule 1
1565
CRANBERRY
1566
CRATAEGUS
CUNEATA
A,E,H
1567
CRATAEGUS
LAEVIGATA
A,E,H
1568
CRATAEGUS
MONOGYNA
A,E,H
1569
CRATAEGUS
PINNATIFIDA
A,E,H
1570
CRATEVA NURVALA A,E,H
1571
CREATINE
A,E

label:
- (PROFES) 'Seek professional advice
before long term use'.
1572
CREATINE
MONOHYDRATE
A,E

label:
1573
CREATINE
PHOSPHATE
A,E

label:
1574
CREATININE

dermal application and not for use in
1575
CREOSOL

176
Schedule 1

no more than 5%.
must be no more 1%.
1576
CREOSOTE

1577
CRESOL
Only for use as a preservative in

topical medicines.
The concentration of phenols
(including cresols and xylenols and
any other homologue of phenol)
boiling below 220 degrees centigrade
label:
- (CRESOL) 'Contains cresol' (or
1578
CRESYL
ISOBUTYRATE

fragrance.
1579
CRITHMUM
MARITIMUM
WHOLE PLANT
EXTRACT

in the eye.
1580
CROCUS SATIVUS
A,H
1581
CROSCARMELLOSE

177
Schedule 1
SODIUM

1582
CROSPOVIDONE
1583
CROTON
CASCARILLA
A,H

material.
1584
CROTON ELUTERIA
A,H

material.
1585
CRYPTOMERIA
JAPONICA
A,H
1586
CUBEB OIL
A,H
1587
CUBEBENE

flavour.
no more than 5%.
1588
CUCUMBER
1589
CUCUMIS MELO
A,H
1590
CUCUMIS SATIVUS
A,E,H
1591
CUCURBITA
MAXIMA
A,E,H
1592
CUCURBITA
MOSCHATA
A,H
178
Schedule 1
1593
CUCURBITA PEPO
A,E,H
1594
CULLEN
CORYLIFOLIUM
A,H
1595
CUMIC ALCOHOL

fragrance.
1596
CUMIN OIL
A,E,H
1597
CUMINALDEHYDE

no more than 5%.
must be no more 1%.
1598
CUMINUM
CYMINUM
A,H
1599
CUMINYL NITRILE

fragrance.
1600
CUPRESSUS
ARIZONICA
A,H
1601
CUPRESSUS
FUNEBRIS
A,E,H
1602
CUPRESSUS
MACROCARPA
A,H
179
Schedule 1
1603
CUPRESSUS
SEMPERVIRENS
A,E,H
1604
CUPRIC ACETATE
MONOHYDRATE

1605
CUPRIC ARSENITE

1606
CUPRIC CITRATE
A,E,H
When for oral or sublingual use,

copper is a mandatory component of
Cupric citrate.
The percentage of copper from cupric
citrate should be calculated based on
the molecular weight of cupric citrate.
than 750 micrograms of copper from
Cupric citrate per the recommended
daily dose or the medicine must not
contain more than 1.86 milligrams of
cupric citrate per the recommended
daily dose.
1607
CUPRIC CITRATE
HEMIPENTAHYDRA
TE
A,E,H

cupric citrate hemipentahydrate.
citrate hemipenthydrate should be
weight of cupric citrate
hemipenthydrate.
than 750 micrograms of copper from
cupric citrate hemipentahydrate per the
recommended daily dose OR the
medicine must not contain more than
2.13 milligrams of cupric citrate
180
Schedule 1
hemipentahydrate per the

1608
CUPRIC OXIDE
A,E,H

Cupric oxide.
oxide should be calculated based on
the molecular weight of cupric oxide.
5 mg of copper.
1609
CUPRIC SULFATE
A,E,H

cupric sulfate.
sulfate should be calculated based on
the molecular weight of cupric sulfate.
5 mg of copper.
181
Schedule 1

1610
CUPRIC SULFATE
MONOHYDRATE
A,E,H

cupric sulfate monohydrate.
sulfate monohydrate should be
weight of cupric sulfate monohydrate.
5 mg of copper.
When used topically, cupric sulfate is
a mandatory component of cupric
sulfate monohydrate.
1611
CUPRIC SULFATE
PENTAHYDRATE
A,E,H
Where for oral or sublingual use,

cupric sulfate pentahydrate.
sulfate pentahydrate should be
weight of cupric sulfate pentahydrate.
5 mg of copper.
When used topically cupric sulfate is a
mandatory component of cupric
sulfate pentahydrate.
The percentage of cupric sulfate from
cupric sulfate pentahydrate should be
182
Schedule 1

weight of cupric sulfate pentahydrate.
The indication'For mineral (may state
1612
CURCULIGO
ORCHIOIDES
A,H
1613
CURCUMA
AROMATICA
A,H
1614
CURCUMA LONGA
A,E,H
1615
CURCUMA
XANTHORRHIZA
A,H
1616
CURCUMA
ZEDOARIA
A,H
1617
CURCUMIN
A,E,H
1618
CUSCUTA
EPITHYMUM
A,H
1619
CUSCUTA
EUROPAEA
A,H
1620
CUSCUTA
HYGROPHILAE
A,H
1621
CUSCUTA
RACEMOSA
A,H
1622
CUSPARIA
FEBRIFUGA
A,H
1623
CYAMOPSIS
TETRAGONOLOBA
A,E,H
1624
CYANOCOBALAMIN
A,E,H
Permitted for excipient use as a colour

in topical and oral medicines.

183
Schedule 1
medicine label:
balanced diet.
The following indications are
permitted for the medicine:
- (VIT3) 'May assist in the
management of dietary vitamin B12
deficiency.'
- (VB121) 'Source of vitamin B12.
Can assist in maintaining normal
blood.'
- (VB122) 'Source of vitamin B12.
Can assist in maintaining normal
blood. Blood tonic.'
1625
CYANOMETHYLPHE
NYL MENTHANE
CARBOXAMIDE
For dental use only in proprietary

ingredients.
flavour.
no more than 5%.
1626
CYATHULA
OFFICINALIS
A,H
1627
CYCLAMEN
ALDEHYDE
1628
CYCLAMEN
PURPURASCENS
A,H
1629
CYCLOHEXADECEN
ONE-8

in topical medicines.

fragrance.
184
Schedule 1

1630
CYCLOHEXANE

flavour.
no more than 5%.
1631
1632
CYCLOHEXANE, 1ETHENYL-1METHYL-2-(1METHYLETHENYL)4-(1METHYLETHYL)-,
DIDEHYDRO DERIV.
CYCLOHEXANEETH
ANOL

fragrance.
fragrance.
1633
CYCLOHEXYL
ACETATE

fragrance.
1634
CYCLOHEXYL
PHENETHYL ETHER

fragrance.
1635
CYCLOHEXYL
SALICYLATE

fragrance.
185
Schedule 1

1636
CYCLOMETHICONE

1637
CYCLOPENTADECA
NONE

fragrance.
1638
CYDONIA OBLONGA
A,H
1639
CYMBOPOGON
FLEXUOSUS
A,E,H
The concentration or Aldehydes

calculated as citral in the medicine
must be no more than 5% for topical
use.
1640
CYMBOPOGON
MARTINI
A,H

use.
1641
CYMBOPOGON
NARDUS
A,H

use.
1642
CYMBOPOGON
SCHOENANTHUS
A,E,H

use.
1643
CYNANCHUM
ATRATUM
A,H
1644
CYNANCHUM
STAUNTONII
A,E,H
1645
CYNARA
SCOLYMUS
A,E,H
186
Schedule 1
1646
CYNODON
DACTYLON
A,E,H
1647
CYNOMORIUM
SONGARICUM
A,H
1648
CYPERUS LONGUS
A,H
1649
CYPERUS
ROTUNDUS
A,H
1650
CYPRESS OIL

fragrance.
1651
CYPRIPEDIUM
PARVIFLORUM VAR.
PUBESCENS
A,H
1652
CYSTEINE
1653
CYSTEINE
HYDROCHLORIDE
1654
CYSTEINE
HYDROCHLORIDE
MONOHYDRATE
1655
CYSTINE
1656
CYTISUS
SCOPARIUS
A,H
Sparteine is a mandatory component

of Cytisus scoparius.
The concentration of Spartiene in the
0.001%.
1657
D-ALPHATOCOPHEROL
A,E

medicine label:
187
Schedule 1

balanced diet.
1658
D-ALPHATOCOPHERYL
ACETATE
A,E,H

medicine label:
balanced diet.
1659
D-ALPHATOCOPHERYL ACID
SUCCINATE
A,E

medicine label:
balanced diet.
1660
D-ALPHATOCOPHERYL
PHOSPHATES

1661
D-BORNEOL

fragrance.
1662
D-CARVONE
188
Schedule 1

no more than 5%.
must be no more 1%.
1663
D-FENCHONE

flavour.
no more than 5%.
1664
D-LIMONENE

no more than 5%.
must be no more 1%.
1665
D-PULEGONE

flavour.
no more than 5%.
The concentration of d-pulegone in the
1666
D-RIBOSE-LCYSTEINE

Cysteine is a mandatory component of
D-Ribose-L-Cysteine.
The medicine must provide no more
189
Schedule 1
than 450 mg of cysteine per maximum

1667
DACTYLIS
GLOMERATA
A,H
1668
DACTYLORHIZA
INCARNATA SUBSP.
INCARNATA
A,H
1669
DAEMONOROPS
DRACO
A,E,H
1670
DAHLIA PINNATA
A,H
1671
DALBERGIA
ODORIFERA
A,H
1672
DAMIANA LEAF
POWDER
1673
DANDELION LEAF
DRY
A,H
1674
DANDELION LEAF
POWDER
A,H
1675
DANDELION ROOT
DRY
A,H
1676
DANDELION ROOT
POWDER
A,H
1677
DAPHNE GENKWA
A,H
1678
DAPHNE
MEZEREUM
A,H
1679
DATE
1680
DATURA
STRAMONIUM
A,H

material.

is a mandatory component of Datura
stramonium.
190
Schedule 1

calculated as hyoscyamine from all
more than 300 micrograms/Kg or 300
1681
DAUCUS CAROTA
A,E,H
1682
DAVANA OIL

no more than 5%.
must be no more 1%.
1683
DEA-OLETH-3
PHOSPHATE

dermal application and not be included
in topical medicines intended for use
in the eye.
label:
- (EYE) 'Avoid contact with eyes'
1684
1685
DECAHYDRO2,2,6,6,7,8,8HEPTAMETHYL-2HINDENO(4,5-B)
FURAN
DECAHYDRO-BETANAPHTHYLACETAT

fragrance.
191
Schedule 1
fragrance.
1686
DECAHYDRO-BETANAPHTHYLFORMAT
E

fragrance.
1687
DECAHYDROSPIRO(
FURAN-2(3H),5'(4,7)METHANO(5H)IN
DENE)
1688
DECALACTONE

no more than 5%.
must be no more 1%.
1689
DECANAL

no more than 5%.
must be no more 1%.
1690
DECANAL
DIMETHYL ACETAL

flavour.
192
Schedule 1

no more than 5%.
1691
DECARBOXY
CARNOISINE
DIHYDROCHLORIDE

in the eye.
must be no more than 0.05.
1692
DECENAL

fragrance.
1693
DECYL ACETATE

no more than 5%.
must be no more 1%.
1694
DECYL ALCOHOL

no more than 5%.
must be no more 1%.
1695
DECYL GLUCOSIDE

dermal application.
193
Schedule 1
1696
DECYL OLEATE

dermal application.
1697
DECYLENE GLYCOL

1698
DEER - RED
1699
DEER ANTLER
CARTILAGE

1700
DEER VELVET
ANTLER POWDER
Medicines that contain 'deer velvet

antler powder' as the therapeutically
active ingredient are subject to the
following conditions:
(i) the medicines are for oral use only;
(ii) the antlers (including the velvet)
are sourced only from red deer
(Cervus elaphus), elk/wapiti (Cervus
canadensis), or a crossbreed of these
species;
(iii) the deer are sourced only from
farmed stock bred and raised in New
Zealand;
(iv) the deer are sourced only from
herds farmed for food in accordance
with the Animal Products Act 1999
(New Zealand) and the regulations
made under that Act; and
(v) the antlers are removed from the
deer only according to the Animal
Welfare Act 1999 (New Zealand) and
the regulations made under that Act.
1701
DEER VELVET
ANTLER SLICE
Medicines that contain 'deer velvet

antler slice' as the therapeutically
active ingredient are subject to the
194
Schedule 1
following conditions:
(i) the medicines are for oral use only;
(ii) the antlers (including the velvet)
are sourced only from red deer
(Cervus elaphus), elk/wapiti (Cervus
canadensis), or a crossbreed of these
species;
(iii) the deer are sourced only from
farmed stock bred and raised in New
Zealand;
(iv) the deer are sourced only from
herds farmed for food in accordance
with the Animal Products Act 1999
(New Zealand) and the regulations
made under that Act; and
(v) the antlers are removed from the
deer only according to the Animal
Welfare Act 1999 (New Zealand) and
the regulations made under that Act.
1702
DEERTONGUE
ABSOLUTE

fragrance.
1703
DEHYDROACETIC
ACID

dermal application.
label:
- (DACACD) 'Contains dehydroacetic
acid [quantity]' (or words to that
effect).
1704
DEHYDROMENTHOF
UROLACTONE

195
Schedule 1
flavour.
no more than 5%.
1705
DEHYDROXANTHAN
GUM

in the eye.
1706
DELPHINIUM
STAPHISAGRIA
A,H
The concentration of the equivalent

dry Delphinium staphisagria in the
1707
DELTADAMASCONE

fragrance.
1708
DELTADECALACTONE

no more than 5%.
must be no more 1%.
1709
DELTADODECALACTONE

no more than 5%.
196
Schedule 1

must be no more 1%.
1710
DELTANONALACTONE

no more than 5%.
must be no more 1%.
1711
DELTAOCTALACTONE

no more than 5%.
must be no more 1%.
1712
DELTATETRADECALACTO
NE

flavour.
no more than 5%.
1713
DELTATOCOPHEROL
1714
DELTAUNDECALACTONE

no more than 5%.
197
Schedule 1

1715
DEMINERALISED
FISH
PROTEOGLYCAN
EXTRACT
1716
DENATONIUM
BENZOATE
1717
DENDROBIUM
NOBILE
A,H
1718
DESCURAINIA
SOPHIA
A,H
1719
DESMODIUM
STYRACIFOLIUM
A,H
1720
DESMODIUM
TRIQUETUM
A,H
1721
DEVIL'S CLAW
TUBER DRY
A,H
1722
DEVIL'S CLAW
TUBER POWDER
A,H
1723
DEXPANTHENOL
A,E

medicine label:
balanced diet.
1724
DEXTRAN 20

198
Schedule 1

1725
DEXTRAN 40
A,E
1726
DEXTRATES
1727
DEXTRIN
1728
DEXTRIN
PALMITATE

in the eye.
1729
DHA/EPA RICH
SCHIZOCHYTRIUM
ALGAL OIL
Only for use in oral medicines. The

ratio of docosahexaenoic acid (DHA)
to eicosapentaenoic acid (EPA) must
be 2:1, and must be present in
combination with other ingredients.
1730
DI-C12-13 ALKYL
MALATE

in the eye.
1731
DI-C12-15 ALKYL
FUMARATE
Only for use in topical medicines forr

in the eye.
1732
1733
DI-N-PROPYL
ISOCINCHOMERONA
TE
DI-PPG-3 MYRISTYL
ETHER ADIPATE

dermal application.
199
Schedule 1
in the eye.
1734
DIACETIN

no more than 5%.
must be no more 1%.
1735
DIACETYL

no more than 5%.
must be no more 1%.
1736
DIACETYL
TARTARIC ACID
ESTERS OF MONOAND DIGLYCERIDES
1737
DIAMMONIUM
LAURYL
SULFOSUCCINATE
1738
DIANTHUS
SUPERBUS
A,H
1739
DIAZOLIDINYL
UREA

flavour.
no more than 5%.

dermal application.
200
Schedule 1
The medicine requires requires the

medicine label:
- (DUREA) 'Contains diazolidinyl
urea' (or words to that effect).
1740
DIBASIC SODIUM
PHOSPHATE
A,E,H

mineral supplementation, sodium is a
mandatory component of dibasic
sodium phosphate.
The percentage of Sodium from
Dibasic sodium phosphate should be
weight of Dibasic sodium phosphate.
When used in a solid preparation, the
pH of a 10 g/L aqueous solution must
not be more than 11.5.
When used in a liquid or a semi-solid
preparation, the pH of the preparation
must not exceed 11.5.
1741
DIBASIC SODIUM
PHOSPHATE
DIHYDRATE
A,E,H

201
Schedule 1

sodium phosphate dihydrate.
Dibasic sodium phosphate dihydrate
molecular weight of Dibasic sodium
phosphate dihydrate.
1742
DIBASIC SODIUM
PHOSPHATE
DODECAHYDRATE
A,E,H

sodium phosphate dodecahydrate.
The percentage of sodium from
Dibasic sodium phosphate
dodecahydrate should be calculated
202
Schedule 1
dodecahydrate.
1743
DIBASIC SODIUM
PHOSPHATE
HEPTAHYDRATE
A,E,H

sodium phosphate heptahydrate.
The amount of sodium in the active
on the molecular weight of dibasic
sodium phosphate heptahydrate.
203
Schedule 1

1744
DIBASIC SODIUM
PHOSPHATE
MONOHYDRATE
A,E,H

sodium phosphate monohydrate.
monohydrate should be calculated
monohydrate.
204
Schedule 1

1745
DIBENZYL KETONE

no more than 5%.
must be no more 1%.
1746
DIBUTYL ADIPATE

dermal application.
1747
DIBUTYL
PHTHALATE

dermal application.
1748
DIBUTYL SEBACATE
1749
DIBUTYLAMINE

flavour.
no more than 5%.
1750
DICAPRYLYL
CARBONATE

dermal application.
1751
DICAPRYLYL ETHER

dermal application.
1752
DICAPRYLYL
MALEATE

205
Schedule 1

in the eye.
1753
DICETYL
PHOSPHATE

1754
DICHLOROBENZYL
ALCOHOL
1755
DICHLOROMETHAN
E

The residual solvent limit for
Dichloromethane is 6 mg per
1756
DICTAMNUS ALBUS
A,H
1757
DICTAMNUS
DESYCARPUS
A,H
1758
DICYCLOHEXYL
DISULFIDE

flavour.
no more than 5%.
1759
DIEFFENBACHIA
SEGUINE

1760
DIETHANOLAMINE

dermal application.
1761
DIETHYL

206
Schedule 1
CITRACONATE
flavour.
no more than 5%.
1762
DIETHYL
MALONATE

no more than 5%.
must be no more 1%.
1763
DIETHYL
PHTHALATE
1764
DIETHYLAMINO
HYDROXYBENZOYL
HEXYL BENZOATE

sunscreens for dermal application and
1765
DIETHYLAMINOMET
HYLCOUMARIN

dermal application.
1766
DIETHYLDIMETHYL
-2CYCLOHEXENONE

fragrance.
1767
DIETHYLENE
GLYCOL

fragrance.
207
Schedule 1

1768
DIETHYLENE
GLYCOL
MONOETHYL ETHER

dermal application.
1769
DIETHYLHEXYL-2,6NAPHTHALATE

in the eye.
label:
1770
DIETHYLHEXYL
CARBONATE

in medicines intended for use in the
eye or on damaged skin.
1771
DIETHYLHEXYL
SEBACATE

dermal application.
1772
DIETHYLHEXYL
SYRINGYLIDENEMA
LONATE

in the eye.
1773
DIETHYLTOLUAMID
E

dermal application.
208
Schedule 1

label:
- (DEET) 'WARNING: May be
dangerous; particularly to children, if
you use large amounts on the skin,
clothes or bedding or on large areas of
the body, especially if you keep using
it for a long time.'
1774
DIGITALIS LEAF
DRY
A,H
The concentration of Digitalis leaf dry

in the product must be no more than
10mg/Kg or 10mg/L or 0.001%.
1775
DIGITALIS LEAF
POWDER
A,H
The concentration of Digitalis leaf

powder in the product must be no
more than 10mg/Kg or 10mg/L or
0.001%.
1776
DIGITALIS
PURPUREA
A,H

Digitalis purpurea in the medicine
10mg/L or 0.001%.
1777
DIGLYCOL/CHDM/IS
OPHTHALATES/SIP
COPOLYMER

dermal application.
1778
DIHEXYL
FUMARATE

fragrance.
1779
DIHYDRO-ALPHATERPINEOL

flavour.
no more than 5%.
209
Schedule 1
1780
DIHYDRO-BETAIONONE

no more than 5%.
must be no more 1%.
1781
DIHYDROISOJASMONE

fragrance.
1782
DIHYDRO JASMONE

fragrance.
1783
DIHYDRO
TERPINYLACETATE

fragrance.
1784
DIHYDROACTINIDIO
LIDE

flavour.
no more than 5%.
1785
DIHYDROAMBRETT
OLIDE

210
Schedule 1
fragrance.
1786
DIHYDROCARVYL
ACETATE

flavour.
no more than 5%.
1787
DIHYDROCOUMARI
N

no more than 5%.
must be no more 1%.
1788
DIHYDROEUGENOL

fragrance.
1789
DIHYDROGENATED
TALLOW PHTHALIC
ACID AMIDE

in the eye.
1790
DIHYDROINDENYL2,4-DIOXANE

fragrance.
211
Schedule 1

1791
DIHYDROLINALOOL

fragrance.
1792
DIHYDROMYRCENO
L

no more than 5%.
must be no more 1%.
1793
DIHYDROMYRCENY
L ACETATE

fragrance.
1794
DIHYDROXYACETO
NE

dermal application.
1795
DIISOPROPYL
ADIPATE

in the eye.
1796
DIISOPROPYL
SEBACATE

eye.
212
Schedule 1

1797
DIISOSTEARYL
DIMER
DILINOLEATE

dermal application.
1798
DILAURYL
THIODIPROPIONATE

dermal application.
1799
DILL HERB OIL
A,E,H
1800
DILL SEED OIL
A,E,H
1801
DILL WEED OIL

flavour.
no more than 5%.
1802
DIMER
DISTEARYLTRICAR
BONATE

dermal application and not to be used
eye.
1803
DIMETHICONE 12500
1804
DIMETHICONE 4000

in the eye.
1805
DIMETHICONE
CROSSPOLYMER

213
Schedule 1
1806
DIMETHICONE
SILYLATE

in the eye.
1807
DIMETHICONE/MET
HICONE
COPOLYMER

in the eye.
1808
DIMETHICONE/VINY
L DIMETHICONE
CROSSPOLYMER

in the eye.
1809
DIMETHYL 3CYCLOHEXENE-1CARBOXALDEHYDE

fragrance.
1810
DIMETHYL
ANTHRANILATE

no more than 5%.
must be no more 1%.
1811
DIMETHYL BENZYL
CARBINOL

214
Schedule 1
fragrance.
1812
DIMETHYL BENZYL
CARBINYL
ACETATE

no more than 5%.
must be no more 1%.
1813
DIMETHYL BENZYL
CARBINYL
BUTYRATE

no more than 5%.
must be no more 1%.
1814
DIMETHYL BENZYL
CARBINYL
ISOBUTYRATE

fragrance.
1815
DIMETHYL
PHENYLETHYL
CARBINOL

fragrance.
1816
DIMETHYL
215
Schedule 1
PHTHALATE

fragrance.
1817
DIMETHYL
POLYSILOXANE

flavour.
no more than 5%.
1818
DIMETHYL
SUCCINATE

flavour.
no more than 5%.
1819
DIMETHYL SULFATE E

flavour.
no more than 5%.
1820
DIMETHYL SULFIDE

no more than 5%.
must be no more 1%.
1821
DIMETHYL
SULFONE
216
Schedule 1
1822
DIMETHYL
SULFOXIDE

flavour.
no more than 5%.
1823
DIMETHYLACETAL

flavour.
no more than 5%.
1824
DIMETHYLCYCLOH
EXYLETHOXY
ISOBUTYLPROPANO
ATE

fragrance.
1825
DIMETHYLGLYCINE
HYDROCHLORIDE
1826
DIMETHYLOL
DIMETHYL
HYDANTOIN

dermal application.
1827
DIMETICONE 1.5

dermal application.


1828
DIMETICONE 10
1829
DIMETICONE 100
1830
DIMETICONE 1000
1831
DIMETICONE 1510

dermal application.

printing ink.
217
Schedule 1

1832
DIMETICONE 2

dermal application.
1833
DIMETICONE 20

dermal application.
1834
DIMETICONE 200

dermal application.
1835
DIMETICONE 30

in the eye.
The concentration is the medicine
1836
DIMETICONE 350
Only for use in topical and oral

medicines.
When used orally, the maximum daily
dose must be no more than 7.5mg.
1837
DIMETICONE 360

dermal application.
1838
DIMETICONE 450

dermal application.
1839
DIMETICONE 5

dermal application.
1840
DIMETICONE 50

dermal application.
1841
DIMETICONE 5000

dermal application.
218
Schedule 1
1842
DIMETICONE 6

in the eye.
1843
DIMETICONE
COPOLYOL

dermal application.
1844
DIMETICONE
COPOLYOL
PHOSPHATE

dermal application.
1845
DIMETICONE
CROSSPOLYMER-3

1846
DIMETICONE/PEG10/15
CROSSPOLYMER

in the eye.
1847
DIMETICONOL

dermal application.
1848
DIMETICONOL
STEARATE

in the eye.
1849
DIMOCARPUS
LONGAN
A,H
1850
DIOCTYL ADIPATE
219
Schedule 1
dermal application.
1851
DIOCTYL MALEATE

dermal application.
1852
DIOCTYL
SUCCINATE

dermal application.
1853
DIOCTYL
TEREPHTHALATE

no more than 5%.
must be no more 1%.
1854
DIOLAMINE C8-18
PERFLUOROALKYLE
THYL PHOSPHATE

in the eye.
1855
DIOLAMINE CETYL
PHOSPHATE
1856
DIOSCOREA
COLLETTII
A,H
1857
DIOSCOREA
COLLETTII VAR.
HYPOGLAUCA
A,H
1858
DIOSCOREA
JAPONICA
A,H
1859
DIOSCOREA
OPPOSITIFOLIA
A,H
1860
DIOSCOREA
A,H

in the eye.
220
Schedule 1
POLYSTACHYA
1861
DIOSCOREA
SEPTEMLOBA
A,H
1862
DIOSCOREA
VILLOSA
A,E,H
1863
DIOSPYROS KAKI
A,E,H
1864
DIOXYBENZONE

label:
- (AVOID) 'Avoid prolonged exposure
in the sun' (or words to this effect)
- (SUNPRO) 'Wear protective clothing
- hats and eyewear when exposed to
the sun' (or words to this effect).
1865
DIPENTAERYTHRIT
YL
HEXACAPRYLATE/H
EXACAPRATE

on damaged skin.
1866
1867
DIPENTAERYTHRIT
YL
TETRAHYDROXYST
EARATE/TETRAISOS
TEARATE
DIPENTAERYTHRIT
YL TRIPOLYHYDROXYSTE
ARATE

in the eye.
in the eye.
221
Schedule 1

1868
DIPHENYL
DIMETHICONE

dermal application.
1869
DIPHENYL
METHANE

fragrance.
1870
DIPHENYL OXIDE

no more than 5%.
must be no more 1%.
1871
DIPOTASSIUM
GLYCYRRHIZATE

in the eye.
1872
DIPROPIONYL

flavour.
no more than 5%.
1873
DIPROPYLENE
GLYCOL

dermal application.
1874
DIPROPYLENE
GLYCOL

222
Schedule 1
DIBENZOATE

in the eye.
1875
DIPROPYLENE
GLYCOL
SALICYLATE

dermal application.
1876
DIPSACUS ASPER
A,H
1877
DIPSACUS
JAPONICUS
A,H
1878
DIPTERYX
ODORATA
A,E,H
1879
DISODIUM
ASCORBYL
SULFATE

dermal application.
1880
DISODIUM
COCOAMPHODIACE
TATE

dermal application.
1881
DISODIUM
COCOAMPHODIPRO
PIONATE

in the eye.
1882
DISODIUM
DIMETICONE
COPOLYOL
SULFOSUCCINATE

in the eye.
1883
DISODIUM EDETATE

223
Schedule 1

1884
DISODIUM
ETHYLENE
DICOCAMIDE PEG-15
DISULFATE

1885
DISODIUM
GUANYLATE

flavour.
no more than 5%.
1886
DISODIUM
INOSINATE

flavour.
no more than 5%.
1887
1888
DISODIUM
LAURIMINODIPROPI
ONATE
TOCOPHERYL
PHOSPHATES
DISODIUM NADH

in the eye.
dermal application.
1889
DISODIUM
OLEAMIDO PEG-2

224
Schedule 1
SULFOSUCCINATE
included in medicines for use in the

eye.
1890
DISODIUM PHENYL
DIBENZIMIDAZOLE
TETRASULFONATE

label:
in the sun' (or words to that effect)
1891
DISODIUM
RICINOLEAMIDO
MEASULFOSUCCINATE

in the eye.
1892
DISODIUM RUTINYL
DISULFATE

in the eye.
1893
DISODIUM
STEAROYL
GLUTAMATE

in the eye.
225
Schedule 1
1894
DISTARCH
PHOSPHATE

in the eye.
1895
DISTEARDIMONIUM
HECTORITE

included for medicines intended for
use in the eye.
1896
DISTEARETH-6
DIMONIUM
CHLORIDE

dermal application.
1897
DISTEARYL
PHTHALIC ACID
AMIDE

in the eye.
1898
DISTEARYLDIMONI
UM CHLORIDE

in the eye.
1899
DIVINYLDIMETHICO
NE/DIMETHICONE
COPOLYMER

in the eye.
1900
DL-ALPHATOCOPHEROL
A,E

226
Schedule 1

medicine label:
balanced diet.
1901
DL-ALPHATOCOPHERYL
ACETATE
A,E,H

medicine label:
balanced diet.
1902
DL-ALPHATOCOPHERYL ACID
SUCCINATE
A,E,H

medicine label:
balanced diet.
1903
DL-BORNEOL
1904
DL-LIMONENE
1905
DL-THREONINE
A,E
1906
DOCOSAHEXAENOI
C ACID (DHA) - RICH
OIL DERIVED FROM
MICROALGAE
SCHIZOCHYTRIUM
SP.

dermal application.
Only for use in oral medicines and

must be present in combination with
other ingredients.
227
Schedule 1
1907
DOCUSATE SODIUM
1908
DODECAHYDRO3A,6,6,9ATETRAMETHYLNAP
HTHO(2,1-B)FURAN
DODECANENITRILE
1909

fragrance.
fragrance.
1910
DODECENAL

no more than 5%.
must be no more 1%.
1911
DODECENE

in the eye.
1912
DODECYL ACETATE

flavour.
no more than 5%.
228
Schedule 1
1913
DODECYL
ISOBUTYRATE

flavour.
no more than 5%.
1914
DOLICHOS LABLAB
A,H
1915
DOLOMITE
A,E,H

for oral and sublingual use:
(SCI-BONDIOP-PR) 'Provides a
minimum daily dose of 290mg of
elemental calcium. A diet deficient in
calcium can lead to osteoporosis in
later life'
(SCI-NUMCALE-AP) 'Provides a
minimum daily dose of 290mg of
elemental calcium which may assist in
the prevention of osteoporosis when
dietary intake is inadequate.'
1916
DRACAENA DRACO
A,H
1917
DRECHSLERA
SOROKINIANA
A,H
1918
DRIMIA INDICA
A,H
1919
DRIMIA MARITIMA
A,H
1920
DROMETRIZOLE
TRISILOXANE

label:
229
Schedule 1

1921
DROSERA ANGLICA
A,H
1922
DROSERA
BURMANNI
A,H
1923
DROSERA
INTERMEDIA
A,H
1924
DROSERA
RAMENTACIA
A,H
1925
DROSERA
ROTUNDIFOLIA
A,E,H
1926
DROSERA
ROTUNDIFOLIA MIS
A,H
1927
DRYNARIA
FORTUNEI
A,H
1928
DRYOBALANOPS
AROMATICA
A,H
1929
DRYOPTERIS FILIXMAS
1930
DULACIA
INOPIFLORA
A,H
1931
DUNALIELLA
SALINA
A,E,H
1932
DURVILLAEA
ANTARCTICA
EXTRACT
DWARF PINENEEDLE OIL
1933


dermal application.
230
Schedule 1

no more than 5%.
must be no more 1%.
1934
DYSPHANIA
AMBROSIOIDES
A,H
Volatile oil components (of Dysphania

ambrosioides) are mandatory
components of Dysphania
ambrosioides.
1935
ECAMSULE

label:
1936
ECHINACEA
ANGUSTIFOLIA
A,E,H
1937
ECHINACEA
PALLIDA
A,E,H
1938
ECHINACEA
PURPUREA
A,E,H
1939
ECHINOPS SPINOSUS A,H
1940
ECLIPTA
PROSTRATA
A,H
1941
ECTOIN

application and not to be used in
231
Schedule 1
topical medicines intended for use in

the eye.
1942
EDETATE SODIUM

dermal application and nasal
medicines.
1943
EDETIC ACID

1944
EICHHORNIA
CRASSIPES
A,H
1945
ELAEAGNUS
ANGUSTIFOLIA
A,H
1946
ELAEIS GUINEENSIS
A,E,H
1947
ELASTIN

dermal application.
1948
ELDER FLOWER
ABSOLUTE

flavour.
no more than 5%.
1949
ELDER FLOWER
BLACK DRY
A,E,H
1950
ELDER FLOWER
BLACK POWDER
A,H
1951
ELECAMPANE
RHIZOME DRY
A,H
1952
ELECAMPANE
RHIZOME POWDER
A,H
232
Schedule 1
1953
ELEMI OIL

fragrance.
1954
ELEMI RESINOID

fragrance.
1955
ELEMOL

fragrance.
1956
ELEOCHARIS
TUBEROSA
A,H
1957
ELETTARIA
CARDAMOMUM
A,E,H
1958
ELEUTHEROCOCCU
S NODIFLORUS
A,H
1959
ELEUTHEROCOCCU
S ROOT DRY
A,H
1960
ELEUTHEROCOCCU
S ROOT POWDER
A,H
1961
ELEUTHEROCOCCU
S SENTICOSUS
A,H
1962
ELSHOLTZIA
SPLENDENS
A,H
1963
ELYMUS REPENS
A,E,H
233
Schedule 1
1964
EMU OIL
A,E
Emu oil ingredients must meet the

following two requirements:
1) the manufacturing process is to
include steps such as cooking, fat
drying or deodorising which ensures
the temperature of the oil reaches at
least 60 degrees C for a minimum 5
minutes or at least 100 degrees C for a
minimum of 1 minute, and
2) the sponsor is to hold a veterinary
certificate indicating that the emus
from which the raw material was
extracted were healthy and fit for
human consumption.
1965
ENOXOLONE

dermal application.
1966
ENZYME MODIFIED
CREAM

flavour.
no more than 5%.
1967
EPHEDRA
DISTACHYA
A,H
Ephedrine and Pseudoephedrine (of

Ephedra distachya) are mandatory
components of Ephedra distachya and
must be declared in the application.
The concentration of ephedrine from
all ingredients in the product must be
0.001%.
1968
EPHEDRA SINICA
A,H
Ephedrine and Pseudoephedrine (of

Ephedra sinica) are mandatory
components of Ephedra sinica.
The concentration of ephedrine from
all ingredients in the product must be
0.001%.
234
Schedule 1
1969
EPIGAEA REPENS
A,H
1970
EPILOBIUM
ANGUSTIFOLIUM
Only for use in topical sunscreens for

in the eye.
The extract must be processed from
the flower, leaf and stem (herb top
flowering) of the plant.
The extracts used must be: 1:20 in
100% water or 1:2 in 100% water.
The concentrations of Epilobium
angustifolium must be no more than
0.75% for a 1:2 extract in 100% water,
and 5% for a 1:20 extract in 100%
water.
1971
EPILOBIUM
PALUSTRE
A,H
1972
EPILOBIUM
PARVIFLORUM
A,H
1973
EPIMEDIUM
BREVICORNU
A,H
1974
EPIMEDIUM
GRANDIFLORUM
A,H
1975
EPIMEDIUM
SAGITTATUM
A,H
1976
EPOXY CEDRENE

fragrance.
1977
EQUISETUM
ARVENSE
A,E,H
1978
EQUISETUM
A,H
235
Schedule 1
HIEMALE
1979
ERGOCALCIFEROL
A,E

more than 25 micrograms of Vitamin
D.
medicine label:
balanced diet.
1980
ERGOTHIONEINE

in the eye.
1981
ERIGERON
BREVISCAPUS
A,H
1982
ERIOBOTRYA
JAPONICA
A,H
1983
ERIOCAULON
BUERGERIANUM
A,H
1984
ERIODICTYON
CRASSIFOLIUM
A,H
1985
ERIODICTYON
A,H
236
Schedule 1
GLUTINOSUM
1986
ERODIUM
CICUTARIUM
A,H
1987
ERUCA SATIVA
A,H
1988
ERYTHORBIC ACID
1989
ERYTHRITOL

in the eye.
1990
ERYTHROSINE
Only for use as a colour for oral and

topical use.
1991
ERYTHROSINE
ALUMINIUM LAKE
Only for use as a colour for oral and

topical use.
1992
ERYTHRULOSE

in the eye.
label:
- (EYE) 'Avoid contact with eyes'.
1993
ESCHSCHOLZIA
CALIFORNICA
A,H
1994
ESTRONE

1995
ETHANOL
A,E

237
Schedule 1

When the concentration of ethanol
from all ingredients in the medicine is
more than 3%, the medicine requires
the medicine label:
- (ETHAN) 'Contains ethanol or
contains alcohol'.
1996
ETHANOL ABSOLUTE
A,E

When the concentration of ethanol
from all ingredients in the medicine is
more than 3%, the medicine requires
the medicine label:
contains alcohol'
1997
ETHER
The concentration of ether in the

1998
ETHOHEXADIOL

dermal application.
label:
- (EHEXAD) 'Contains ethohexadiol'
1999
ETHOXYLATED
NONYLPHENOL

fragrance.
238
Schedule 1

2000
ETHOXYMETHOXY
CYCLODODECANE

no more than 5%.
must be no more 1%.
2001
ETHYL-2-METHYL1,3-DIOXOLANE-2ACETATE

fragrance.
2002
ETHYL-2-METHYL-4PENTENOATE

no more than 5%.
must be no more 1%.
2003
ETHYL-2METHYLPENTENOA
TE

flavour.
no more than 5%.
2004
ETHYL (2,4DIMETHYL-[1,3]
DIOXOLAN-2-YL)
ACETATE

fragrance.
239
Schedule 1

2005
2006
ETHYL
(3AR,4S,7R,7AR)REL- OCTAHYDRO4,7METHANO[3AH]IND
ENE-3ACARBOXYLATE
ETHYL 2BUTENOATE

fragrance.
flavour.
no more than 5%.
2007
2008
ETHYL 2-ETHYL-6,6DIMETHYL-2CYCLOHEXENECAR
BOXYLATE
ETHYL 2-HEXYL
ACETOACETATE

fragrance.
fragrance.
2009
ETHYL 2METHYLBUTYRATE

no more than 5%.
must be no more 1%.
240
Schedule 1
2010
ETHYL 2METHYLPENTANOA
TE

no more than 5%.
must be no more 1%.
2011
2012
2013
ETHYL 2,3,6,6TETRAMETHYL-2CYCLOHEXENECAR
BOXYLATE
ETHYL
2,6,6,TRIMETHYL1,3CYCLOHEXADIENE1-CARBOXYLATE
ETHYL 3HEXENOATE

fragrance.
fragrance.
flavour.
no more than 5%.
2014
ETHYL 3HYDROXYBUTYRAT
E

flavour.
no more than 5%.
2015
ETHYL 3HYDROXYHEXANO

241
Schedule 1
ATE
flavour.
no more than 5%.
2016
ETHYL 3MERCAPTOPROPION
ATE

flavour.
no more than 5%.
2017
ETHYL 3METHYLTHIOPROPI
ONATE

flavour.
no more than 5%.
2018
ETHYL 4,7OCTADIENOATE

flavour.
no more than 5%.
2019
ETHYL ACETATE
The residual solvent limit for ethyl

acetate is 50 mg per recommended
daily dose.
2020
ETHYL
ACETOACETATE

no more than 5%.
242
Schedule 1
must be no more 1%.

2021
ETHYL ACRYLATE
2022
ETHYL ALCOHOL

no more than 5%.
must be no more 1%.
2023
ETHYL AMYL
KETONE

no more than 5%.
must be no more 1%.
2024
ETHYL
ANTHRANILATE

flavour.
no more than 5%.
2025
ETHYL BENZOATE

no more than 5%.
must be no more 1%.
243
Schedule 1
2026
ETHYL BENZOYL
ACETATE

fragrance.
2027
ETHYL
BUTYLACETYLAMI
NOPROPIONATE

dermal application. The concentration
7.5%.
label:
- (EYE2) 'May be irritant to the eyes
(or words to that effect)'.
2028
ETHYL BUTYRATE

no more than 5%.
must be no more 1%.
2029
ETHYL CAPRATE

no more than 5%.
must be no more 1%.
2030
ETHYL CAPROATE

244
Schedule 1
no more than 5%.
must be no more 1%.
2031
ETHYL CAPRYLATE

flavour.
no more than 5%.
2032
ETHYL CINNAMATE

flavour.
no more than 5%.
2033
ETHYL CROTONATE

flavour.
no more than 5%.
2034
ETHYL ENANTATE

no more than 5%.
2035
ETHYL FORMATE
245
Schedule 1

flavour.
no more than 5%.
2036
ETHYL
HYDROXYBENZOAT
E
medicine label:
- (TOTBNZ) Contains
2037
ETHYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
2038
ETHYL
ISOVALERATE
2039
ETHYL LACTATE

no more than 5%.
246
Schedule 1
must be no more 1%.

2040
ETHYL LAURATE

no more than 5%.
must be no more 1%.
2041
ETHYL LEVULATE

flavour.
no more than 5%.
2042
ETHYL LEVULINATE

flavour.
no more than 5%.
2043
ETHYL LINALOOL

no more than 5%.
must be no more 1%.
2044
ETHYL LINALYL
ACETATE

fragrance.
247
Schedule 1

2045
ETHYL LINOLEATE

dermal application.
2046
ETHYL LINOLENATE

dermal application.
2047
ETHYL
MACADAMIATE

in the eye.
2048
ETHYL MALTOL
2049
ETHYL MENTHANE
CARBOXAMIDE

flavour.
no more than 5%.
2050
ETHYL
METHACRYLATE

dermal application.
2051
ETHYL
METHYLPHENYLGL
YCIDATE

no more than 5%.
must be no more 1%.
2052
ETHYL METICONE

in the eye.
248
Schedule 1

2053
ETHYL MYRISTATE

no more than 5%.
must be no more 1%.
2054
ETHYL OLEATE

no more than 5%.
must be no more 1%.
2055
ETHYL ORTHOMETHOXYBENZYL
ETHER

fragrance.
2056
ETHYL
OXYHYDRATE

no more than 5%.
must be no more 1%.
249
Schedule 1
2057
ETHYL PALMITATE

no more than 5%.
must be no more 1%.
2058
ETHYL PARAANISATE

flavour.
no more than 5%.
2059
ETHYL
PELARGONATE

no more than 5%.
must be no more 1%.
2060
ETHYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
2061
ETHYL PROPIONATE

250
Schedule 1
no more than 5%.
must be no more 1%.
2062
ETHYL
RICINOLEATE

fragrance.
2063
ETHYL SALICYLATE

no more than 5%.
must be no more 1%.
2064
ETHYL SEBACATE

flavour.
no more than 5%.
2065
ETHYL STEARATE

no more than 5%.
2066
ETHYL SUCCINATE
251
Schedule 1

flavour.
no more than 5%.
2067
ETHYL TARTRATE

fragrance.
2068
ETHYL TRANS-2,
CIS-4DECADIENOATE

flavour.
no more than 5%.
2069
ETHYL TRANS-3HEXENOATE

flavour.
no more than 5%.
2070
ETHYL
UNDECYLENATE

fragrance.
2071
ETHYL VALERATE

fragrance.
252
Schedule 1
2072
ETHYL VANILLIN
2073
ETHYLBISIMINOME
THYL GUAIACOL
MANGANESE
CHLORIDE
2074
ETHYLCELLULOSE
2075
ETHYLENE
BRASSYLATE

dermal application.

fragrance.
2076
ETHYLENE GLYCOL
The residual solvent limit for ethylene

glycol is 6.2 mg per recommended
daily dose.
2077
ETHYLENE GLYCOL
MONOPALMITOSTE
ARATE

dermal application.
2078
ETHYLENE/ACRYLI
C ACID COPOLYMER

2079
ETHYLENE/PROPYL
ENE/STYRENE
COPOLYMER HYDROGENATED
The combined concentration of

ethylene/propylene/styrene copolymer
- hydrogenated must be no more than
9%.
2080
ETHYLENE/VINYL
ACETATE
COPOLYMER

in the eye.
253
Schedule 1

2081
ETHYLENEDIAMINE

dermal application.
2082
ETHYLENEDIAMINE/
HYDROGENATED
DIMER
DILINOLEATE
COPOLYMER BIS-DIC14-18 ALKYL
AMIDE

in the eye.
ETHYLENEDIAMINE/
STEARYL DIMER
DILINOLEATE
COPOLYMER
2083

2084
ETHYLHEXYL
BENZOATE

2085
ETHYLHEXYL
METHOXYCRYLENE

in the eye.
2086
ETHYLHEXYL
TRIAZONE

sunscreens.
in the eye.
254
Schedule 1

2087
ETHYLHEXYLGLYC
ERIN

in the eye.
2088
ETIDRONIC ACID

dermal application only.
2089
EUCALYPTUS DIVES
A,E,H

Eucalyptus dives.
the total concentration of the oil in the
preparation is more than 25% and the
more than 15 mL but no more than
the container. The medicine requires
the following warning statements on
the medicine label:
When the concentration of the oil in
is no more than 15 mL, a restricted
flow insert must be fitted on the
container. The medicine requires the
255
Schedule 1

medicine label:
2090
EUCALYPTUS
FRUTICETORUM
A,E,H

Eucalyptus fruticetorum.
the medicine label:
medicine label:
256
Schedule 1
2091
EUCALYPTUS
GLOBULUS
A,E,H

Eucalyptus globulus.
the medicine label:
medicine label:
2092
EUCALYPTUS
MACRORHYNCHA
A,E,H

Eucalyptus macrorhyncha.
257
Schedule 1

the medicine label:
medicine label:
2093
EUCALYPTUS OIL
A,E,H

Eucalyptus oil.
258
Schedule 1

the medicine label:
medicine label:
2094
EUCALYPTUS
RADIATA
A,E,H

Eucalyptus radiata.
the medicine label:
259
Schedule 1

medicine label:
2095
EUCALYPTUS
ROSTRATA
A,E,H

Eucalyptus rostrata.
the medicine label:
260
Schedule 1

medicine label:
2096
EUCALYPTUS
TERETICORTIS
A,E,H

Eucalyptus tereticortis.
the medicine label:
medicine label:
261
Schedule 1

2097
EUCOMMIA
ULMOIDES
A,H
2098
EUGENOL

dermal application.
When the concentration of Eugenol in
the medicine label:
is no more than 15mL, a restricted
medicine label:
2099
EUGENYL ACETATE

262
Schedule 1

no more than 5%.
must be no more 1%.
2100
EUONYMUS
ATROPURPUREUS
A,H
2101
EUONYMUS
EUROPAEUS
A,H
2102
EUPATORIUM
FORTUNEI
A,H
2103
EUPATORIUM
JAPONICUM
A,H
2104
EUPATORIUM
PERFOLIATUM
A,H
2105
EUPATORIUM
PURPUREUM
A,H
2106
EUPHAUSIA
SUPERBA OIL

material.

label:
- (SFOOD) 'Derived from seafood'
or
- (SHELL) 'Contains crustacean
shellfish'.
2107
EUPHORBIA
CYPARISSIAS
A,H
2108
EUPHORBIA DRY
A,H
2109
EUPHORBIA
HETERODOXA
A,H
263
Schedule 1
2110
EUPHORBIA HIRTA
A,H
2111
EUPHORBIA
LATHYRIS
A,H
Levodopa (of Euphorbia lathyris) is a

mandatory component of Euphorbia
lathyris.
The concentration of Levodopa (of
Euphorbia lathyris) in the medicine
must be no more than 10mg/kg or
10mg/L or 0.001%.
2112
EUPHORBIA
PEKINENSIS
A,H
2113
EUPHORBIA PEPLUS
2114
EUPHORBIA
POWDER
A,H
2115
EUPHORBIA
RESINIFERA
A,H
2116
EUPHORBIA
SIEBOLDIANA
A,H
2117
EUPHRASIA
OFFICINALIS
A,H
2118
EUROPEAN HORNET
2119
EURYALE FEROX
A,H
2120
EUTERPE
OLERACEA
2121
EVENING PRIMROSE
OIL
A,E,H
2122
EVERNIA
PRUNASTRA
EXTRACT



from the fruit only.

fragrance.
264
Schedule 1
265
Schedule 1
Column 1
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine

2123
FABIANA
IMBRICATA
A,H
2124
FAGOPYRUM
ESCULENTUM
A,H
2125
FAGUS
GRANDIFOLIA
A,H
2126
FAGUS SYLVATICA
A,H
2127
FALLOPIA
JAPONICA
A,E,H
2128
FALLOPIA
MULTIFLORA
A,H

- (FALLMUL) 'Warning: Fallopia
multiflora may harm the liver in some
people. Use under the supervision of a
healthcare professional.'
2129
FARNESOL

no more than 5%.
must be no more 1%.
2130
FAST GREEN FCF

and topical use.
2131
FENCHONE
Schedule 1

no more than 5%.
must be no more 1%.
2132
FENCHYL ACETATE

fragrance.
2133
FENCHYL ALCOHOL

no more than 5%.
must be no more 1%.
2134
FENNEL BITTER
SEED DRY
A,E,H
2135
FENNEL LEAF
2136
FENNEL OIL
A,E,H
2137
FENNEL SWEET
SEED DRY
A,E,H
2138
FENUGREEK

flavour.
Schedule 1
no more than 5%.

2139
FENUGREEK OIL
Fenugreek oil is permitted for use only

in combination with other permitted
ingredients as a flavour. If used in a
flavour the total flavour concentration
in a medicine must be no more than
5%.
2140
FERRIC AMMONIUM
CITRATE
A,E,H
When for internal use, iron is a

mandatory component of ferric
ammonium citrate.
The percentage of iron from ferric
ammonium citrate should be
weight of ferric ammonium citrate.
must contain a daily dose of no more
than 24 mg of iron.
If the divided dosage form contains
more than 5 mg of iron per dosage unit
(excluding up to 10 mg of iron oxide
when used as an excipient), the
primary pack must contain no more
than 750 mg of iron.
In undivided preparations, the primary
pack must contain no more than 750
mg of iron (excluding iron oxides
when present as an excipient at a
quantity of no more than 1%).
Divided preparations with a dose of
more than 5 mg of elemental iron per
dosage unit and more than 250 mg of
elemental iron in the total contents of
the container are required to have a
child resistant closure.
Undivided preparations containing
more than 250 mg of elemental iron in
the total contents of the container are
required to have a child resistant
Schedule 1
closure.
oral or sublingual use:
- (SUPMIN) 'For mineral (may state
the mineral) supplementation.'
- (IRON1) 'Source of iron. Can assist
in maintaining normal blood.'
in maintaining normal blood. Blood
tonic'
- (IRON5) 'Source of iron. Iron is
necessary for the formation of
haemoglobin which transports oxygen
to the tissues.'
- (IRON6) 'May assist in the
management of dietary iron
deficiency.'
2141
FERRIC CHLORIDE
A,E,H

chloride.
The percentage of Iron from ferric
chloride should be calculated based on
the molecular weight of ferric
chloride.
than 24 mg of iron.
Schedule 1

closure.
tonic'
to the tissues.'
deficiency.'
2142
FERRIC CHLORIDE
HEXAHYDRATE
A,E,H

chloride hexahydrate should be
Schedule 1
weight of ferric chloride hexahydrate.

than 24 mg of iron.
closure.
tonic'
Schedule 1

to the tissues.'
deficiency.'
2143
FERRIC
GLYCEROPHOSPHA
TE
A,E,H

glycerophosphate.
glycerophosphate should be calculated
ferric glycerophosphate.
than 24 mg of iron.
Schedule 1
closure.
permitted when the medicine is fororal
or sublingual use:
tonic'
to the tissues.'
deficiency.'
2144
FERRIC OXIDE
2145
FERRIC PHOSPHATE

2146
FERRIC
PYROPHOSPHATE
A,H

pyrophosphate.
The percentage of Iron from ferric
pyrophosphate should be calculated
ferric pyrophosphate.
than 24 mg of iron.
Schedule 1

closure.
tonic'
to the tissues.'
deficiency.'
2147
FERROSOFERRIC
When used in undivided preparations

for internal use and the concentration
Schedule 1
OXIDE
of iron oxide in the medicine is more

than 1%, it is considered part of the
total iron content.
When used in divided preparations for
internal use, the concentration in the
medicine must be no more than 10 mg
per dosage unit.
2148
FERROSOFERRIC
PHOSPHATE

2149
FERROUS
FUMARATE
A,H

mandatory component of ferrous
fumarate.
The percentage of Iron from ferrous
fumarate should be calculated based
on the molecular weight of ferrous
fumarate. The following indications
are only permitted when the medicine
is for oral or sublingual use:(SUPMIN) 'For mineral (may state the
mineral) supplementation.'
tonic'
to the tissues.'
deficiency.'
2150
FERROUS
GLUCONATE
A,E,H

gluconate.
10
Schedule 1

gluconate.
than 24 mg of iron.
closure.
tonic'
11
Schedule 1

to the tissues.'
deficiency.'
2151
FERROUS
GLUCONATE
DIHYDRATE
A,E,H

gluconate dihydrate.
gluconate dehydrate should be
weight of ferrous gluconate dihydrate.
than 24 mg of iron.
12
Schedule 1
closure.
tonic'
to the tissues.'
deficiency.'
2152
FERROUS IODIDE

2153
FERROUS LACTATE
TRIHYDRATE
A,E,H

lactate trihydrate.
The amount of iron in the active
lactate trihydrate.
medicine must contain a daily dose of
no more than 24 mg of iron.
13
Schedule 1

quantity of no more than1%).
more than 5mg of elemental iron per
dosage unit and more than 250
milligrams of elemental iron in the
total contents of the container are
closure.
more than 250 milligrams of elemental
iron in the total contents of the
container are required to have a child
resistant closure.
tonic'
to the tissues.'
deficiency.'
2154
FERROUS
PHOSPHATE
A,E,H

14
Schedule 1
OCTAHYDRATE
phosphate octahydrate.
phosphate octahydrate.
closure.
resistant closure.
15
Schedule 1

tonic'
to the tissues.'
deficiency.'
2155
FERROUS PICRATE

2156
FERROUS SULFATE
A,E,H

sulfate.
sulfate.
16
Schedule 1

closure.
resistant closure.
tonic'
to the tissues.'
deficiency.'
2157
FERROUS SULFATE
HEPTAHYDRATE
A,E,H

sulfate heptahydrate.
The percentage of iron from ferrous
sulfate heptahydrate should be
weight of ferrous sulfate heptahydrate.
than 24 mg of iron.
17
Schedule 1

closure.
tonic'
to the tissues.'
18
Schedule 1

deficiency.'
2158
FERULA ASSAFOETIDA
A,E,H
2159
FERULA FOETIDA
A,E,H
2160
FERULA
GALBANIFLUA
A,E,H
2161
FERULA
RUBRICAULIS
A,E,H
2162
FERULA SUMBUL
A,H
2163
FERULIC ACID
2164
FESTUCA ELATIOR
A,H
2165
FEVERFEW HERB
DRY
A,H
2166
FEVERFEW HERB
POWDER
A,H
2167
FICUS CARICA
A,E,H
2168
FICUS PUMILA
A,H
2169
FIG
2170
FIG DRY
A,H
2171
FILIPENDULA
ULMARIA
A,H
2172
FIR BALSAM
ABSOLUTE

dermal application.

fragrance.
2173
FIR NEEDLE OIL

CANADIAN
A,E
19
Schedule 1
2174
FIR NEEDLE OIL

SIBERIAN
A,E
2175
FIRMIANA SIMPLEX
A,E,H
2176
FISH OIL - NATURAL
A,E
When therapeutic indications for this

product are made against Vitamin A or
colecalciferol (Vitamin D), they are
mandatory components of fish oil natural.
maximum daily dose.
- (VITA2) 'WARNING: If you are
effect].' NOTE: Position this warning
use.
20
Schedule 1
- (VITA4) 'WARNING - When taken

defects.' NOTE: Position this warning
use.
- (VITA3) 'The recommended daily
retinol equivalents for men.'
more than 25 micrograms of vitamin
D.
medicine label:
balanced diet.
intent)' and 'A diet deficient in calcium
can lead to osteoporosis in later life'
are permitted only for oral use.
2177
FISH OIL - RICH IN

OMEGA-3 ACIDS
2178
FLEMINGIA
MACROPHYLLA
A,H
2179
FLOUVE OIL

21
Schedule 1

no more than 5%.
must be no more 1%.
2180
FLUORESCEIN
SODIUM
2181
FOENICULUM
VULGARE
A,E,H
2182
FOLIC ACID

more than 500 micrograms of folic
acid.
If the maximum recommended daily
dose provides less than 400
micrograms of folic acid, the
following indications are not
permitted:
- (NEUR1) 'Provides a daily dose of
400-500mcg of folic acid or folate.
Contains folic acid which, if taken
daily for one month before conception
and during pregnancy, may reduce the
risk of women having a child with
birth defects of the brain and/or spinal
cord such as the neural tube defects
known as spina bifida and
anencephaly.'
- (NEUR2) 'Provides a daily dose of
400-500mcg of folic acid or folate.
Contains folic acid which, if taken
daily for one month before conception
and during pregnancy, may reduce the
risk of having a child with spina
bifida/neural tube defects.'
The following indications are
permitted only when the medicine is
22
Schedule 1
for oral or sublingual use:

- (FOLIC1) 'Source of folic acid. Can
assist in maintaining normal blood.'
- (VIT2) 'May assist in the
management of dietary folate
deficiency.'
- (FOLIC2) 'Source of folic acid. Can
assist in maintaining normal blood.
Blood tonic.'
medicine label:
balanced diet.
2183
FOOD ORANGE 6

and topical use.
2184
FOOD ORANGE 7

and topical use.
2185
FOOD RED 13

topical use.
2186
FORMALDEHYDE/M
ELAMINE/TOSYLAM
IDE COPOLYMER

dermal application.
2187
FORMIC ACID
2188
FORSYTHIA
SUSPENSA
A,H
2189
FRAGARIA
A,E,H

23
Schedule 1
CHILOENSIS
2190
FRAGARIA VESCA
A,E,H
2191
FRAGARIA
VIRGINIANA
A,E,H
2192
FRAGARIA X
ANANASSA
A,E,H
2193
FRANGULA BARK
DRY
A,H
Glucofrangulins calculated as
glucofrangulin A is a mandatory
component of Frangula bark dry.
label:
that effect]'
that effect]'.
medicine label:
24
Schedule 1

medicine label:
component(s)]'
laxative effect'
label:
2194
FRANGULA BARK
POWDER
A,H
component of Frangula bark powder.
label:
25
Schedule 1

that effect]'
that effect]'.
medicine label:
medicine label:
component(s)]'
laxative effect'
label:
26
Schedule 1

2195
FRANGULA
PURSHIANA
A,H
When for oral use, hydroxyanthracene

derivatives calculated as cascaroside A
is a mandatory component of Frangula
purshiana.
label:
that effect]'
that effect]'.
medicine label:
27
Schedule 1

medicine label:
component(s)]'
laxative effect'
label:
2196
FRAXINUS
AMERICANA
A,H
2197
FRAXINUS
CHINENSIS SUBSP.
RHYNCHOPHYLLA
A,H
2198
FRAXINUS
EXCELSIOR
A,H
2199
FRAXINUS ORNUS
A,H
2200
FRITILLARIA
CIRRHOSA
A,H
2201
FRITILLARIA
THUNDBERGII
A,H
The components Nuzhenide and

secoiridoid glucoside GL3 are only
available when the plant part is seed.
28
Schedule 1
2202
FRITILLARIA
VERTICILLATA
A,H
2203
FRUCTOSE
A,E,H
2204
FUCUS
VESICULOSUS
A,E,H

Fucus vesiculosus.
2205
FUMARIA
OFFICINALIS
A,E,H
2206
FUMARIC ACID
E,H
2207
FUMITORY HERB
DRY
A,H
2208
FUMITORY HERB
POWDER
A,H
2209
FURAMINTON


flavour.
no more than 5%.
2210
FURFURAL

29
Schedule 1

no more than 5%.
must be no more 1%.
2211
FURFURYL
ACETATE

flavour.
no more than 5%.
2212
FURFURYL
ALCOHOL

flavour.
no more than 5%.
2213
FURFURYL
MERCAPTAN

flavour.
no more than 5%.
2214
FUSEL OIL

flavour.
no more than 5%.
2215
GALBANUM OIL

30
Schedule 1
no more than 5%.

must be no more 1%.
2216
GALBANUM
PHENOL

fragrance.
2217
GALBANUM RESIN

fragrance.
2218
GALBANUM
RESINOID

no more than 5%.
must be no more 1%.
2219
GALEGA
OFFICINALIS
A,H
2220
GALEOPSIS
SEGETUM
A,H
2221
GALIUM APARINE
A,H
2222
GALIUM
ODORATUM
A,H
2223
GALIUM PALUSTRE
A,H
31
Schedule 1
2224
GALIUM VERUM
A,H
2225
GALL STONE
2226
GALPHIMIA
GLAUCA
A,H
2227
GAMMA-4DIMETHYL-3CYCLOHEXENE-1PROPANOL
GAMMABUTYROLACTONE
2228


fragrance.
flavour.
no more than 5%.
2229
GAMMACYCLODEXTRIN
2230
GAMMADECALACTONE

dermal application.
2231
GAMMADODECALACTONE

no more than 5%.
must be no more 1%.
2232
GAMMAHEPTALACTONE

32
Schedule 1

no more than 5%.
must be no more 1%.
2233
GAMMAHEXALACTONE

no more than 5%.
must be no more 1%.
2234
GAMMA-IONONE

no more than 5%.
must be no more 1%.
2235
GAMMA-LINOLEIC
ACID
2236
GAMMA-LINOLENIC
ACID
2237
GAMMA-N-METHYL
IONONE

dermal application.

no more than 5%.
33
Schedule 1
must be no more 1%.

2238
GAMMANONALACTONE

no more than 5%.
must be no more 1%.
2239
GAMMAOCTALACTONE

no more than 5%.
must be no more 1%.
2240
GAMMA-TERPINENE

no more than 5%.
must be no more 1%.
2241
GAMMATOCOPHEROL
2242
GAMMAUNDECALACTONE

34
Schedule 1
no more than 5%.

must be no more 1%.
2243
GAMMAVALEROLACTONE

flavour.
no more than 5%.
2244
GANODERMA
LUCIDUM
A,E,H
2245
GARCINIA GUMMIGUTTA

Must be obtained from the rind of the
fruit only.
Must not contain any directions for use
for children or pregnant or lactating
women.
2246
GARCINIA
QUAESITA
A,H
2247
GARDEN BEAN
2248
GARDENIA
JASMINOIDES
A,E
2249
GARDENIA
TAHITENSIS
FLOWER EXTRACT

2250
GARLIC BULB DRY
A,E,H
2251
GARLIC BULB
FRESH
A,H
35
Schedule 1
2252
GARLIC BULB
POWDER
A,E,H
2253
GARLIC CLOVE
POWDER
A,H
2254
GARLIC OIL
A,E,H
2255
GASTRODIA ELATA
A,H
2256
GAULTHERIA
PROCUMBENS
A,E,H

component of Gaultheria procumbens
and must be declared in the
application.
The concentration of Methyl salicylate
0.001%.
2257
GELATIN
A,E
2258
GELATIN HYDROLYSED
A,E
2259
GELIDIUM AMANSII
A,H
36
Schedule 1
Gelidium amansii.
2260
GELLAN GUM
2261
GELSEMIUM DRY
A,H
2262
GELSEMIUM
POWDER
A,H
2263
GELSEMIUM
SEMPERVIRENS
A,H

Gelsemium sempervirens in the
product must be no more than 1mg/Kg
or 1mg/L or 0.0001%.
2264
GENET ABSOLUTE

The concentration of Gelsemium dry

1mg/Kg or 1mg/L or 0.0001%.

no more than 5%.
must be no more 1%.
2265
GENTIAN DRY
A,H
2266
GENTIAN POWDER
A,H
37
Schedule 1
2267
GENTIANA LUTEA
A,E,H
2268
GENTIANA
MACROPHYLLA
A,H
2269
GENTIANA
RHODANTHA
A,H
2270
GENTIANA SCABRA
A,H
2271
GENTIANELLA
AMARELLA
A,H
2272
GERANIAL

flavour.
no more than 5%.
2273
GERANIC ACID

fragrance.
2274
GERANIOL

dermal application.
2275
GERANIUM

fragrance.
2276
GERANIUM
MACULATUM
A,E,H
2277
GERANIUM OIL
A,E,H
2278
GERANIUM OIL
SAPONIFIED

38
Schedule 1
fragrance.
2279
GERANIUM OIL
TERPENELESS

fragrance.
2280
GERANIUM
ROBERTIANUM
A,E,H
2281
GERANIUM ROSE
OIL

flavour.
no more than 5%.
2282
GERANIUM
SIBIRICUM
A,E,H
2283
GERANYL ACETATE

dermal application.
2284
GERANYL ACETONE

no more than 5%.
must be no more 1%.
2285
GERANYL
BUTYRATE

39
Schedule 1

no more than 5%.
must be no more 1%.
2286
GERANYL
CROTONATE

fragrance.
2287
GERANYL ETHYL
ETHER

fragrance.
2288
GERANYL FORMATE

no more than 5%.
must be no more 1%.
2289
GERANYL
ISOBUTYRATE

no more than 5%.
40
Schedule 1
must be no more 1%.

2290
GERANYL
ISOVALERATE

no more than 5%.
must be no more 1%.
2291
GERANYL NITRILE

fragrance.
2292
GERANYL
PROPIONATE

no more than 5%.
must be no more 1%.
2293
GERANYL TIGLATE

fragrance.
2294
GEUM RIVALE
A,H
2295
GEUM URBANUM
A,H
2296
GHATTI GUM
A,E,H
41
Schedule 1
2297
GIGARTINA
MAMILLOSA
A,H

Gigartina mamillosa.
2298
GINGER DRY
A,E,H
2299
GINGER OIL
A,E,H
2300
GINGER OLEORESIN

flavour.
no more than 5%.
2301
GINGER POWDER
A,E,H
2302
GINKGO BILOBA
A,E,H
2303
GLECHOMA
HEDERACEA
A,H
2304
GLECHOMA
A,H
The Ginkgo biloba leaf extract used in

the manufacture of this medicine must
comply with the requirement of
Identification Test B of the monograph
Powdered Ginkgo Extract in the
United States Pharmacopeia 32 National Formulary 27 (USP32NF27). This condition does not apply
to powdered or dried leaf.
42
Schedule 1
LONGITUBA
2305
GLEDITSIA
AUSTRALIS
A,H
2306
GLEDITSIA SINENSIS
A,H
2307
GLEHNIA
LITTORALIS
A,H
2308
GLORIOSA SUPERBA
A,H
Colchicine is a mandatory component

of Gloriosa superba and must be
declared in the application.
The concentration of colchicine in the
product must be no more than 10
2309
GLUCOMANNAN
2310
GLUCONOLACTONE
2311
GLUCOSAMINE
HYDROCHLORIDE
A,E

other than tablet.

label:
2312
GLUCOSAMINE
SULFATE

label:
2313
GLUCOSAMINE
SULFATE
POTASSIUM
CHLORIDE
Potassium chloride is a mandatory

component of glucosamine sulfate
potassium chloride.
label:
43
Schedule 1

- (POTAS) Contains [amount of
potassium in milligrams] mg of
potassium. If you have kidney disease
or are taking heart or blood pressure
medicines - consult your doctor or
pharmacist before use. Keep out of
reach of children.
2314
GLUCOSAMINE
SULFATE SODIUM
CHLORIDE

label:
2315
GLUCOSE
A,E,H
When the medicine is for oral

ingestion and the total amount of all
sugars (monosaccharides and
disaccharides such as glucose, honey,
invert sugar, lactose, maltose, and
sucrose) is more than 100mg in the
maximum daily dose, then the
label:
- (SUGARS) Contains [insert name of
sugar] if medicine contains one sugar
OR Contains sugars' (or words to that
effect) if medicine contains two or
more sugars.
If one of the sugars is lactose then the
medicine also requires the following
label:
- (LACT) Contains lactose' (or words
to that effect).
2316
GLUCOSE - LIQUID

44
Schedule 1

label:
more sugars.
label:
to that effect).
2317
GLUCOSE - SPRAYDRIED LIQUID

flavour.
no more than 5%.
2318
GLUCOSE
GLUTAMATE

dermal application.
2319
GLUCOSE
MONOHYDRATE
A,E,H

disaccharides such as glucose
monohydrate, honey, invert sugar,
lactose, maltose, and sucrose) is more
than 100mg in the maximum daily
dose, then the medicine requires the
medicine label:
45
Schedule 1
more sugars.
label:
to that effect).
2320
GLUCOSYLRUTIN

in the eye.
2321
GLUTAMIC ACID
A,E
2322
GLUTAMIC ACID
HYDROCHLORIDE
A,E,H
2323
GLUTAMINE
A,E,H
2324
GLUTARAL

dermal application.

flavour.
no more than 5%.
2325
GLUTATHIONE
A,E

glutathione can only be used in
medicines with an oral route of
administration and must be indicated
for use in adults only and not in
pregnant or lactating women.
label:
46
Schedule 1
(or words to that effect)

- (ADULT) 'Adults only' (or words to
that effect).
2326
GLYCERETH-26

in the eye.
2327
GLYCEROL
A,E
When used as an active ingredient, it is

dermal application.
2328
GLYCEROL ESTER
OF PARTIALLY
HYDROGENATED
GUM ROSIN

for oral use when the dosage form is
chewing gum.
GLYCERYL
BEHENATE
2329
Must comply with the relevant FCC

monograph and ICH/BP/USP
requirements for residual solvents and
catalysts.
component of Glyceryl behenate.
In medicines for topical use, the
no more than 5%.
In medicines for oral use, Glyceryl
behenate is permitted for use as a
lubricant for tablets and capsules at a
final concentration of 1-3%.
In medicines for oral use, Glyceryl
behenate is permitted for use as a slow
release lipophilic matrix for sustained
release tablets and capsules at a final
concentration of 10-30%.
2330
GLYCERYL
CAPRYLATE

47
Schedule 1
in the eye.
2331
GLYCERYL
DIISOSTEARATE
For use in topical medicines for

dermal application.
2332
GLYCERYL
DILAURATE

dermal application.
2333
GLYCERYL
DIOLEATE

dermal application.
2334
GLYCERYL
DISTEARATE

dermal application.
2335
GLYCERYL
GLUCOSIDE

in the eye.
2336
GLYCERYL
ISOSTEARATE

in the eye.
2337
GLYCERYL
LAURATE

dermal application.
2338
GLYCERYL
LINOLEATE

dermal application.
2339
GLYCERYL
LINOLENATE

dermal application.
2340
GLYCERYL
MONOOLEATE
2341
GLYCERYL
MONOSTEARATE
48
Schedule 1
2342
GLYCERYL
MONOSTEARATE SELF-EMULSIFYING
2343
GLYCERYL
MYRISTATE

dermal application.
2344
GLYCERYL OLEATE
CITRATE

in the eye.
must be no more than 4% of the
formulation.
2345
GLYCERYL
PALMITOSTEARATE
2346
GLYCERYL
POLYACRYLATE

in the eye.
2347
GLYCERYL
POLYMETHACRYLA
TE

dermal application.
2348
GLYCERYL
RICINOLEATE

dermal application.
2349
GLYCERYL
ROSINATE

chewing gum.
Must comply with the relevant FCC
monograph and ICH/BP/USP
requirements for residual solvents and
catalysts.
2350
GLYCERYL
SORBITAN
OLEOSTEARATE

dermal application.
49
Schedule 1
2351
GLYCERYL STARCH

dermal application.
The residual levels of epichlorohydrin
are to be kept below the level of
detection.
2352
GLYCERYL
STEARATE CITRATE

dermal application.
2353
GLYCERYL
TRIACETYL
HYDROXYSTEARAT
E

dermal application.
2354
GLYCERYL
TRIACETYL
RICINOLEATE

dermal application.
2355
GLYCERYL
TRINITRATE

2356
GLYCINE
A,E
2357
GLYCINE MAX
A,E,H
2358
GLYCOGEN

dermal application.
2359
GLYCOL
DISTEARATE

dermal application.
2360
GLYCOLIC ACID

dermal application.

Sponsors should consider the impact

of excipients on the sensitivity of the
skin to sunlight and should ensure the
purpose.
50
Schedule 1
When present as an excipient in

sunscreens, the concentration in the
When used as an excipient ingredient
in other medicines the concentration in
the medicine must be no more than
20%.
If the concentration is more than 5%
but no more than 20%, the pH of the
medicine must be 3.5 or greater.
2361
GLYCOSAMINOGLY
CANS HYDROLYSED
2362
GLYCYRRHIZA
GLABRA
A,E,H
2363
GLYCYRRHIZA
SPECIES

dermal application.

flavour.
no more than 5%.
2364
GLYCYRRHIZA
URALENSIS
A,E,H
2365
GLYCYRRHIZINIC
ACID
2366
GNAPHALIUM
AFFINE
A,H
2367
GNAPHALIUM
POLYCEPHALUM
A,H
2368
GNAPHALIUM
ULIGINOSUM
A,H
2369
GOAT

2370
GOLD
E,H
51
Schedule 1

2371
GOLD CHLORIDE
2372
GOLDEN ROD HERB

DRY
A,E,H
2373
GOLDEN SEAL ROOT

DRY
A,H
2374
GOLDEN SEAL ROOT

POWDER
A,H
2375
GOLDEN SYRUP

Sucrose is a mandatory component of

Golden syrup when the route of
administration of the medicine is oral
or sublingual.
label:
more sugars.
label:
to that effect).
2376
GOMPHRENA
GLOBOSA
A,H
52
Schedule 1
2377
GOOSEBERRY
2378
GOSSYPIUM
HERBACEUM
A,E,H
2379
GRAPE
2380
GRAPE SEED OIL
2381
GRAPE WINE RED
Ethanol is a mandatory component of

Grape wine red.
When the concentration of ethanol in
label:
- (ETHAN) Contains ethanol or
contains alcohol
2382
GRAPE WINE
SHERRY

Grape wine sherry.
label:
contains alcohol
2383
GRAPE WINE WHITE

Grape wine white.
label:
contains alcohol
2384
GRAPEFRUIT
53
Schedule 1
2385
GRAPEFRUIT OIL

no more than 5%.
must be no more 1%.
2386
GRAPEFRUIT OIL TERPENELESS

flavour.
no more than 5%.
2387
GRAPEFRUIT OIL
COLDPRESSED
A,E,H
2388
GRAPEFRUIT OIL
CONCENTRATE

flavour.
no more than 5%.
2389
GRAPEFRUIT OIL
TERPENES AND
TERPENOIDS

no more than 5%.
must be no more 1%.
2390
GRAPHITE

54
Schedule 1
2391
GRATIOLA
LINIFOLIA
A,H
2392
GREATER NETTLE
HERB DRY
A,H
2393
GREATER NETTLE
HERB POWDER
A,H
2394
GREATER NETTLE
ROOT DRY
A,H
2395
GREATER NETTLE
ROOT POWDER
A,H
2396
GREEN LIPPED
MUSSEL
2397
GREEN LIPPED
MUSSEL DRIED
2398
GREEN LIPPED
MUSSEL OIL
2399
GREEN S
Only for use as a colour in topical and

oral medicines.
2400
GRIFOLA
FRONDOSA

oral or sublingual, the medicine
-(WARF) 'Do not take while on
warfarin therapy without medical
advice.'
2401
GRINDELIA
CAMPORUM
A,H
2402
GRINDELIA
ROBUSTA
A,H
2403
GRISALVA

fragrance.
55
Schedule 1

2404
GROUND IVY HERB

DRY
A,H
2405
GROUND IVY HERB

POWDER
A,H
2406
GUAIAC WOOD OIL

no more than 5%.
must be no more 1%.
2407
GUAIACOL
2408
GUAIACUM
OFFICINALE
A,E,H
2409
GUAIACUM RESIN
A,E,H
2410
GUAIACUM
SANCTUM
A,H
2411
GUAIACWOOD
ACETATE
Only for use in medicated space sprays


no more than 5%.
2412
GUAIENE

fragrance.
56
Schedule 1

2413
GUAIYL ACETATE

fragrance.
2414
GUANINE

2415
GUANOSINE

for use in the eye.
than 0.01% in the medicine.
2416
GUAR GUM
A,E,H
2417
GUAR
HYDROXYPROPYLT
RIMONIUM
CHLORIDE
2418
GUAREA RUSBYI
A,H
2419
GUAVA
2420
GURJUN BALSAM


fragrance.
2421
GYMNEMA
SYLVESTRE
A,H
2422
GYMNOCLADUS
DIOICA
A,H
57
Schedule 1
2423
GYNOSTEMMA
PENTAPHYLLUM
2424
GYNURA JAPONICA
A,H
2425
HALIBUT-LIVER OIL
A,E

from the aerial parts of the vine only
(stem, leaves, fruit).
Colecalciferol and Vitamin A are

mandatory components of Halibutliver oil.
D.
maximum daily dose.
58
Schedule 1

use.
use.
medicine label:
balanced diet.
2426
HAMAMELIS LEAF
DRY
A,H
2427
HAMAMELIS LEAF
POWDER
A,H
2428
HAMAMELIS
VIRGINIANA
A,E,H
2429
HAMAMELIS WATER A,E,H

59
Schedule 1
2430
HANDROANTHUS
HEPTAPHYLLUS
A,H
2431
HANDROANTHUS
IMPETIGINOSUS
A,E,H
2432
HARD FAT
2433
HARICOT BEAN
2434
HARPAGOPHYTUM
PROCUMBENS
A,E,H
2435
HARUNGANA
MADAGASCARIENSI
S
A,H
2436
HAZEL NUT
2437
HAZEL NUT OIL
2438
HECTORITE
2439
HEDEOMA
PULEGIOIDES
2440
HEDERA HELIX
A,H

dermal application.

Hedera helix.
2441
HEDTA

2442
HEKLA LAVA

2443
HELESTRALIS

fragrance.
60
Schedule 1
2444
HELIANTHEMUM
NUMMULARIUM
A,H
2445
HELIANTHUS
ANNUUS
A,E,H
2446
HELIANTHUS
TUBEROSUS
A,H
2447
HELICHRYSUM
ANGUSTIFOLIUM
A,E,H
2448
HELICHRYSUM
ARENARIUM
A,H
2449
HELIOTROPYL
ACETATE

fragrance.
2450
HELLEBORUS NIGER
A,H

dose must be no more than 1mg of the
equivalent dry herbal material.
2451
HELLEBORUS
VIRIDIS
A,H

2452
HELONIAS RHIZOME
DRY
A,H
2453
HELONIAS RHIZOME
POWDER
A,H
2454
HEMIDESMUS
INDICUS
A,E,H
2455
HEPTANAL

no more than 5%.
61
Schedule 1

must be no more 1%.
2456
HEPTANAL
DIMETHYL ACETAL

flavour.
no more than 5%.
2457
HEPTANOIC ACID

no more than 5%.
must be no more 1%.
2458
HEPTENAL

flavour.
no more than 5%.
2459
HEPTYL ACETATE

flavour.
no more than 5%.
2460
HEPTYL BUTYRATE

flavour.
62
Schedule 1
no more than 5%.

2461
HEPTYL
UNDECYLENATE

The concentration of the medicine
2462
HERACLEUM
HEMSLEYANUM
A,H
2463
HERNIARIA GLABRA
A,H
2464
HESPERIDIN
A,E
2465
HEX-3-ENYL
ACETATE

fragrance.
2466
HEXAHYDRO-4,7METHANOINDEN-6YL PIVALATE

fragrance.
2467
HEXAMETHYLINDA
NOPYRAN

no more than 5%.
must be no more 1%.
2468
HEXAN-1-OL

63
Schedule 1
no more than 5%.
must be no more 1%.
2469
HEXANE

When used for a route of
administration other than topical, the
residual solvent limit for Hexane is 2.9
mg per recommended daily dose.
2470
HEXANOATE

no more than 5%.
2471
HEXANOIC ACID

no more than 5%.
must be no more 1%.
2472
HEXASODIUM
FYTATE

64
Schedule 1
The concentration of Hexasodium

fytate in the medicine must be no more
than 1.0 %.
2473
HEXENAL

flavour.
no more than 5%.
2474
HEXYL 2METHYLBUTYRATE

fragrance.
2475
HEXYL ACETATE

no more than 5%.
must be no more 1%.
2476
HEXYL BUTYRATE

no more than 5%.
must be no more 1%.
2477
HEXYL CAPROATE

65
Schedule 1
flavour.
no more than 5%.
2478
HEXYL FORMATE

flavour.
no more than 5%.
2479
HEXYL
ISOBUTYRATE

fragrance.
2480
HEXYL
ISOVALERATE

fragrance.
2481
HEXYL LAURATE
2482
HEXYL NICOTINATE
2483
HEXYL SALICYLATE


fragrance.
2484
HEXYL TIGLATE

fragrance.
66
Schedule 1

2485
HEXYLDECANOL

not to be included in topical medicines
2486
HEXYLENE GLYCOL
2487
HIBISCUS
ESCULENTUS
A,H
2488
HIBISCUS
MUTABILIS
A,H
2489
HIBISCUS ROSASINENSIS


flavour.
no more than 5%.
2490
HIBISCUS
SABDARIFFA
A,E,H
2491
HIERACIUM
PILOSELLA
A,H
2492
HIMATANTHUS
LANCIFOLIUS
A,E,H
2493
HIPPOPHAE
RHAMNOIDES
A,E,H
2494
HIRSCHFELDIA
INCANA
A,H

component of Hirschfeldia incana
when the plant part is seed.
When the herbal substance is derived
from the seed, the maximum
67
Schedule 1

more than 20mg of allyl
isothiocyanate.
2495
HISTAMINE
DIHYDROCHLORIDE
2496
HISTIDINE
2497
HISTIDINE
HYDROCHLORIDE
A,E,H
2498
HO LEAF OIL


no more than 5%.
must be no more 1%.
2499
HO WOOD OIL

no more than 5%.
must be no more 1%.
2500
HOLCUS LANATUS
A,H
2501
HOLY THISTLE
HERB DRY
A,H
2502
HOLY THISTLE
HERB POWDER
A,H
2503
HOMALOMENA
OCCULTA
A,H
68
Schedule 1
2504
HOMOSALATE
A,E

sunscreens.
In other products, only for use as an
excipient in topical medicines for
for use in the eye.
The concentration of homosalate in the
2505
HONEY
A,E

oral, the medicine requires the
medicine label:
- (BABY2) 'Not suitable for infants
under the age of twelve months' (or
label:
more sugars.
label:
to that effect).
69
Schedule 1
2506
HONEY - PURIFIED
A,E

oral, the medicine requires the
medicine label:
- (BABY2) 'Not suitable for infants
under the age of twelve months' (or
label:
more sugars.
label:
to that effect).
2507
HONEY BEE

2508
HONEY EXTRACT

in the eye.
2509
HONEY POWDER
70
Schedule 1

flavour.
no more than 5%.
2510
HOP STROBILE DRY
A,H
2511
HOP STROBILE
POWDER
A,H
2512
HOPS OIL
A,E,H
2513
HORDEUM
DISTICHON
A,E,H
Gluten is a mandatory component

when the plant part is seed, and must
be declared in the application when the
route of administration is other than
topical and mucosal.
label:
2514
HORDEUM
VULGARE
A,E,H

when the plant part is seed, and must
be declared in the application when the
label:
2515
HOREHOUND
EXTRACT

71
Schedule 1
flavour.
no more than 5%.
2516
HORSE RADISH
E,H
Volatile oil components (of Armoracia

rusticana) is a mandatory component
of Horse radish.
dose must be no more than 20 mg of
volatile oil components (of Armoracia
rusticana).
2517
HOTTONIA
PALUSTRIS
A,H
2518
HOUTTUYNIA
CORDATA
A,H
2519
HOVENIA DULCIS
A,H
2520
HUMULUS LUPULUS
A,E,H
2521
HYALURONIC ACID

2522
HYDNOCARPUS
ANTHELMINTICA
A,H
When the medicine is for other than

topical use and the plant part is seed,
the maximum recommended daily
equivalent dry seed.
2523
HYDRANGEA
ARBORESCENS
A,H
2524
HYDRANGEA
PANICULATA
A,H
2525
HYDRASTIS
CANADENSIS
A,E,H
2526
HYDRATED SILICA
Only for use when the route of

administration is other than inhalation.
2527
HYDROCHLORIC
E,H
72
Schedule 1
ACID
2528
HYDROCOTYLE
UMBELLATA
A,H
2529
HYDROFLUORIC
ACID

2530
HYDROGEN
CYANIDE

2531
HYDROGEN
PEROXIDE
A,E
When used as the active ingredient, it

is only for use in topical medicines for
dermal application.
The concentration of hydrogen
peroxide in the medicine must be no
more than 3%.
2532
HYDROGENATED
COCO-GLYCERIDES

for use in the eye.
2533
HYDROGENATED
DIMER
DILINOLEYL/DIMET
HYLCARBONATE
COPOLYMER

for use in the eye.
must be no more than 4% in the
product.
73
Schedule 1
2534
HYDROGENATED
LANOLIN
2535
HYDROGENATED
PALM KERNEL OIL

in the eye.
2536
HYDROGENATED
PALM OIL

in the eye.
Polycyclic aromatic hydrocarbons
must be kept below the level of
detection.
2537
HYDROGENATED
POLYDECENE

in the eye.
2538
HYDROGENATED
TALLOW
GLYCERIDE

in the eye.
2539
HYDROLIAC

flavour.
no more than 5%.
2540
HYDROLYSED
ADANSONIA
DIGITATA LEAF

74
Schedule 1
POLYSACCHARIDES
for use in the eye.

2541
HYDROLYSED
ALGIN

for use in the eye.
2542
HYDROLYSED
CEREAL SOLIDS

flavour.
no more than 5%.
2543
HYDROLYSED
ELASTIN

dermal application.
2544
HYDROLYSED
JOJOBA ESTERS

for use in the eye.
2545
HYDROLYSED
KERATIN

in the eye.
2546
HYDROLYSED MILK
PROTEIN
2547
HYDROLYSED MILK
PROTEIN - ALPHA
CASOZEPINE

75
Schedule 1
ENRICHED
label:
- (BABY3) 'Not suitable for use in
children under the age of twelve
months - except on professional
advice'
milk.'
2548
HYDROLYSED RICE
PROTEIN

for use in the eye.
2549
HYDROLYSED
WHEAT
PROTEIN/PVP
CROSSPOLYMER

for use in the eye.
2550
HYDROLYSED
YEAST PROTEIN

2551
HYDROQUINONE
DIMETHYL ETHER

no more than 5%.
must be no more 1%.
2552
HYDROXOCOBALA
76
Schedule 1
MIN

medicine label:
balanced diet.
2553
HYDROXYACETOPH
ENONE

2554
HYDROXYAPATITE
A,E

- (SCI-BONDIOP-PR) 'A diet
osteoporosis in later life'
- (SCI-NUMCALE-AP) 'Calcium may
help prevent osteoporosis when dietary
intake is inadequate'
- (CALC1) 'Source of calcium.
increased after menopause'
- (CALC2) 'Source of calcium. A
tissue for children and older adults'
- (CALC3) 'Source of calcium.
77
Schedule 1
maximise bone'
- (CALC4) 'Source of calcium. A diet
osteoporosis in later life.'
2555
HYDROXYCITRATE
COMPLEX
2556
HYDROXYCITRIC
ACID
2557
HYDROXYCITRONE
LLAL
Hydroxycitrate complex must contain

one or more of the three salts (calcium,
sodium or potassium hydroxycitrate)
of hydroxycitric acid.

no more than 5%.
must be no more 1%.
2558
HYDROXYCITRONE
LLALMETHYLANTHRANI
LATE

no more than 5%.
must be no more 1%.
2559
HYDROXYCITRONE
LLAL DIMETHYL
ACETAL

no more than 5%.
78
Schedule 1

must be no more 1%.
2560
HYDROXYCITRONE
LLOL

fragrance.
2561
HYDROXYETHYL
CETEARAMIDOPROP
YLDIMONIUM
CHLORIDE

for use in the eye.
2562
HYDROXYETHYL
UREA

for use in the eye.
than 1%.
2563
HYDROXYLATED
MILK GLYCERIDES

for use in the eye.
than 0.1%.
2564
HYDROXYLYSINE
A,E
2565
HYDROXYMETHYLC
ELLULOSE
2566
HYDROXYOCTACOS
ANYL
HYDROXYSTEARAT
E

dermal application.
2567
HYDROXYPALMITO

79
Schedule 1
YL SPHINGANINE

than 0.1%.
2568
HYDROXYPROLINE
A,E
2569
HYDROXYPROPYL
DISTARCH
PHOSPHATE

for use in the eye.
than 4%.
2570
HYDROXYPROPYL
STARCH
2571
HYDROXYPROPYLB
ETADEX

dermal application.
2572
HYDROXYSTEARIC
ACID

for use in the eye.
than 9%.
2573
HYETELLOSE
2574
HYLOCEREUS
UNDATUS
A,H
2575
HYMETELLOSE
2576
HYOSCAMUS LEAF
DRY
A,H

and hyoscine are mandatory
components of Hyoscyamus leaf dry.
or 0.00003%.
The concentration of hyoscine in the
80
Schedule 1
medicine must be no more than than

300 micrograms/kg or 300
2577
HYOSCAMUS LEAF
POWDER
A,H

components of Hyoscamus leaf
powder.
or 0.00003%.
2578
HYOSCYAMUS
NIGER
A,H

components of Hyoscyamus niger.
The concentration of hyoscyamine in
the medicine must be no more than 3
micrograms/kg or 3 micrograms/L or
0.3%.
2579
HYPERICUM
ASCYRON
A,H
2580
HYPERICUM
JAPONICUM
A,H
2581
HYPERICUM
PERFORATUM
A,E,H
When used for oral ingestion, the

label:
- (STJOHN) 'St John's Wort affects the
way many prescription medicines
81
Schedule 1
work - including oral contraceptives.

Consult your doctor.'
2582
HYPROLOSE
2583
HYPROMELLOSE
2584
HYPROMELLOSE
PHTHALATE
2585
HYPTIS
SUAVEOLENS
A,H
2586
HYSSOPUS
OFFICINALIS
A,E,H
2587
IBERIS AMARA
A,H
2588
ICHTHAMMOL
2589
ILEX AQUIFOLIUM
A,H
2590
ILEX CHINENSIS
A,H
2591
ILEX
PARAGUARIENSIS
A,E,H


Ilex paraguariensis.
daily dose of more than 1 mg but no
more than 10 mg of caffeine in the
label:
- (CAFFR) The recommended dose of
of caffeine.
daily dose of more than 10 mg of
caffeine in the medicine requires the
82
Schedule 1
medicine label:
- (CAFF) Contains caffeine [state
per gram of product].
2592
ILEX ROTUNDA
A,H
2593
ILEX VERTICILLATA
A,H
2594
ILLICIUM VERUM
A,H
When the plant preparation is oil, and

the concentration in the medicine is
more than 50%, the nominal capacity
of the container must be no more than
50 mL, a restricted flow insert must be
label:
2595
IMIDUREA

dermal application.
label:
- (IMIDUR) 'Contains imidurea [or
words to that effect]'.
2596
IMMORTELLE

flavour.
no more than 5%.
2597
IMMORTELLE OIL

flavour.
83
Schedule 1
no more than 5%.

2598
IMPATIENS

flavour.
no more than 5%.
2599
IMPATIENS
BALSAMINA
A,H
2600
IMPATIENS
GLANDULIFERA
A,H
2601
IMPERATA
CYLINDRICA
A,E,H
2602
INDIGO CARMINE

and topical use.
2603
INDIGO CARMINE
ALUMINIUM LAKE

and topical use.
2604
INDIGOFERA
TINCTORIA
A,H
2605
INDISAN

fragrance.
2606
INDOLE

2607
INDOLENE

fragrance.
84
Schedule 1
2608
INOSITOL
A,E
2609
INULA BRITANNICA
A,H
2610
INULA HELENIUM
A,E,H
2611
INULA RACEMOSA
A,H
2612
INULIN
A,E
2613
INVERT SUGAR

no more than 5%.
2614
INVERT SYRUP
Glucose is a mandatory component of

Invert syrup when the route of
administration is oral or sublingual.
2615
IODINE

concentration in the medicine
(excluding salts derivatives or
iodophors) is more than 2.5%.
2616
IODOPROPYNYL
BUTYLCARBAMATE
For use as an excipient ingredient in

topical medicines only.
The concentration in aqueous
medicines must be no more than 10%.
2617
IONONE
85
Schedule 1
dermal application.
2618
IPECACUANHA DRY
A,H

Ipecacuanha Dry.
2619
IPECACUANHA
POWDER
A,H

Ipecacuanha Powder.
2620
IPECACUANHA
PREPARED
A,H

Ipecacuanha Prepared.
2621
IPECACUANHA
ROOT LIQUID
EXTRACT
A,H
2622
IPOMOEA BATATAS
A,H
2623
IPOMOEA JALAPA
A,H
2624
IRIDOPHYCUS
FLACCIDUM
A,H

Ipecacuanha root liquid extract.

Iridophycus flaccidum.
86
Schedule 1
2625
IRIS DOMESTICA
A,H
2626
IRIS FLORENTINA
A,H
2627
IRIS GERMANICA
A,H
2628
IRIS PALLIDA
A,H
2629
IRIS TENAX
2630
IRIS VERSICOLOR
A,H
2631
IRON
A,H

quantity of no more than1%).
closure.
resistant closure.
87
Schedule 1

tonic'
to the tissues.'
deficiency.'
2632
IRON (II)
BISGLYCINE
SULFATE
TRIHYDRATE

Iron is a mandatory component of iron
(II) bisglycine sulfate trihydrate and
availability is restricted to use as a
The percentage of iron from iron (II)
bisglycine sulfate trihydrate should be
weight of iron (II) bisglycine sulfate
trihydrate.
than 24 mg of iron.
88
Schedule 1

closure.
tonic'
to the tissues.'
deficiency.'
2633
IRON (II)
GLYCINATE

(II) glycinate and availability is
89
Schedule 1
The percentage of iron from iron (II)

glycinate should be calculated based
on the molecular weight of iron (II)
glycinate.
than 24 mg of iron.
closure.
90
Schedule 1

tonic'
to the tissues.'
deficiency.'
2634
IRON (III)
GLYCINATE

(III) glycinate and availability is
The percentage of Iron from iron (III)
on the molecular weight of iron (III)
glycinate.
than 24 mg of iron.
91
Schedule 1

closure.
tonic'
to the tissues.'
deficiency.'
2635
IRON AMINO ACID

CHELATE
A,H

When used internally, iron is a
mandatory component of iron amino
acid chelate.
The concentration of iron in iron
amino acid chelate must be no more
than 25%.
92
Schedule 1

tonic.'
to the tissues.'
deficiency.'
2636
IRON OXIDE BLACK

and topical use.
total iron content.
per dosage unit.
2637
IRON OXIDE RED

and topical use.
total iron content.
per dosage unit.
93
Schedule 1
2638
IRON OXIDE
YELLOW

and topical use.
total iron content.
per dosage unit.
2639
IRON PHOSPHATE
A,E,H
When used internally, iron is a

mandatory component of iron
phosphate and must be declared.
The concentration of iron in iron
phosphate must be no less than 16%.
tonic.'
to the tissues.'
deficiency.'
2640
IRONE
2641
IRVINGIA
94
Schedule 1
GABONENSIS SEED
TRIGLYCERIDES

for use in the eye.
than 0.375%.
2642
ISATIS TINCTORIA
A,H
2643
ISOAMBRETTOLIDE

no more than 5%.
must be no more 1%.
2644
ISOAMYL 2METHYLBUTYRATE

flavour.
no more than 5%.
2645
ISOAMYL ACETATE

no more than 5%.
must be no more 1%.
2646
ISOAMYL ALCOHOL

95
Schedule 1
no more than 5%.

must be no more 1%.
2647
ISOAMYL
BENZOATE

no more than 5%.
must be no more 1%.
2648
ISOAMYL
BUTYRATE

no more than 5%.
must be no more 1%.
2649
ISOAMYL
CAPRYLATE

no more than 5%.
must be no more 1%.
2650
ISOAMYL
CINNAMATE

96
Schedule 1

no more than 5%.
must be no more 1%.
2651
ISOAMYL
CITRONELLYL
KETONE

fragrance.
2652
ISOAMYL FORMATE

no more than 5%.
must be no more 1%.
2653
ISOAMYL
HEXANOATE

no more than 5%.
must be no more 1%.
2654
ISOAMYL
ISOBUTYRATE

no more than 5%.
97
Schedule 1

must be no more 1%.
2655
ISOAMYL
ISOVALERATE

no more than 5%.
must be no more 1%.
2656
ISOAMYL LAURATE

for use in the eye.
than 12%.
2657
ISOAMYL
METHOXYCINNAMA
TE

for use in the eye.
than 10%.
2658
ISOAMYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
2659
ISOAMYL
PROPIONATE

98
Schedule 1
no more than 5%.
must be no more 1%.
2660
ISOAMYL
SALICYLATE

no more than 5%.
must be no more 1%.
2661
ISOBERGAMIATE

fragrance.
2662
ISOBORNEOL

no more than 5%.
must be no more 1%.
2663
ISOBORNYL
ACETATE

99
Schedule 1

no more than 5%.
must be no more 1%.
2664
ISOBORNYL
CYCLOHEXANOL

fragrance.
2665
ISOBUTANE

dermal application.
2666
ISOBUTYL ACETATE

no more than 5%.
must be no more 1%.
2667
ISOBUTYL
ALCOHOL
The residual solvent limit for Isobutyl

alcohol is 50mg per recommended
daily dose.
The concentration of isobutyl alcohol
must be no more than 0.5% of the
formulation.
2668
ISOBUTYL
BENZOATE

flavour.
no more than 5%.
100
Schedule 1
2669
ISOBUTYL BENZYL
CARBINOL

flavour.
no more than 5%.
2670
ISOBUTYL
BUTYRATE

flavour.
no more than 5%.
2671
ISOBUTYL
CAPROATE

flavour.
no more than 5%.
2672
ISOBUTYL
CINNAMATE

flavour.
no more than 5%.
2673
ISOBUTYL
FORMATE

flavour.
no more than 5%.
2674
ISOBUTYL
HYDROXYBENZOAT
E

dermal application.
101
Schedule 1
medicine label:
- (TOTBNZ) Contains
2675
ISOBUTYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
2676
ISOBUTYL
ISOVALERATE

flavour.
no more than 5%.
2677
ISOBUTYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
2678
ISOBUTYL
PROPIONATE

flavour.
102
Schedule 1

no more than 5%.
2679
ISOBUTYL
QUINOLINE

fragrance.
2680
ISOBUTYL
SALICYLATE

dermal application.
2681
ISOBUTYLENE/ISOP
RENE COPOLYMER
Only for oral use when the dosage

form is chewing gum.
The concentration must be consistent
with best practice for the production of
gum delivery systems.
2682
ISOBUTYRALDEHYD
E

flavour.
no more than 5%.
2683
ISOBUTYRIC ACID

no more than 5%.
must be no more 1%.
2684
ISOCETYL ALCOHOL

dermal application.
2685
ISOCETYL
LINOLEOYL
103
Schedule 1
STEARATE
dermal application.
2686
ISOCETYL
STEARATE

dermal application.
2687
ISOCETYL
STEAROYL
STEARATE

for use in the eye.
than 10%.
2688
ISOCYCLOCITRAL

fragrance.
2689
ISODECYL
ISONONANOATE

dermal application.
2690
ISODECYL
NEOPENTANOATE

dermal application.
2691
ISODECYL OLEATE

dermal application.
2692
ISODECYL
SALICYLATE

for use in the eye.
than 2%.
2693
ISODODECANE

dermal application.
2694
ISOEICOSANE

for use in the eye.
104
Schedule 1
than 2%.
2695
ISOEUGENOL

no more than 5%.
must be no more 1%.
2696
ISOEUGENYL
ACETATE

no more than 5%.
must be no more 1%.
2697
ISOEUGENYL
BENZYL ETHER

fragrance.
2698
ISOHEXADECANE

dermal application.
2699
ISOJASMONE

fragrance.
2700
ISOLEUCINE
A,E
105
Schedule 1
2701
ISOMALT
When the quantity of sugar alcohols

per maximum recommended daily
dose is more than 2g, the quantity of
the sugar alcohols must be declared on
the label and the medicine requires the
medicine label:
- (SUGOLS) Products containing
[insert name of sugar alcohol(s) may
have a laxative effect or cause
diarrhoea [or words to that effect].
2702
ISOMENTHONE

no more than 5%.
must be no more 1%.
2703
ISOMETHYLIONONE

fragrance.
2704
ISONONYL
ACETATE

fragrance.
If used as in a fragrance the total
2705
ISONONYL
ISONONANOATE

106
Schedule 1
than 15%.
2706
ISOPENTANE
For dental use only.

than 2%.
2707
ISOPENTANOIC
ACID

no more than 5%.
must be no more 1%.
2708
ISOPHORONE

flavour.
no more than 5%.
2709
ISOPHYTOL

no more than 5%.
must be no more 1%.
2710
ISOPROPYL-3METHYL-BUTANE
THIOATE

fragrance.
107
Schedule 1
2711
ISOPROPYL 2METHYLBUTYRATE

no more than 5%.
must be no more 1%.
2712
ISOPROPYL 4HYDROXYBENZOAT
E

dermal application.
medicine label:
- (TOTBNZ) Contains
2713
ISOPROPYL
ACETATE
2714
ISOPROPYL
ALCOHOL
2715
ISOPROPYL
CAPROATE

dermal application.

flavour.
no more than 5%.
2716
ISOPROPYL
CINNAMATE

flavour.
108
Schedule 1

no more than 5%.
2717
ISOPROPYL
ISOSTEARATE

dermal application.
2718
ISOPROPYL
LANOLATE

dermal application.
2719
ISOPROPYL
LAUROYL
SARCOSINATE

for use in the eye.
than 5.6%.
2720
ISOPROPYL
MYRISTATE
2721
ISOPROPYL
PALMITATE

dermal application.
2722
ISOPROPYL PPG-2
ISODECETH-7
CARBOXYLATE

for use in the eye.
than 10%.
2723
ISOPROPYL
STEARATE

dermal application.
2724
ISOPROPYL
TITANIUM
TRIISOSTEARATE

in the eye.
than 0.2%.
2725
ISOPULEGOL

109
Schedule 1

no more than 5%.
must be no more 1%.
2726
ISORALDEINE 70

fragrance.
2727
ISOSTEARIC ACID

dermal application.
2728
ISOSTEAROYL
HYDROLYSED
COLLAGEN

in the eye.
than 0.3%.
2729
ISOSTEARYL
ALCOHOL

dermal application.
2730
ISOSTEARYL
NEOPENTANOATE

dermal application.
2731
ISOSTEARYL
PALMITATE

in the eye.
than 2%.
2732
ISOTRIDECYL
ALCOHOL

fragrance.
110
Schedule 1

2733
ISOVALERALDEHYD
E

no more than 5%.
must be no more 1%.
2734
ISOVALERIC ACID

no more than 5%.
must be no more 1%.
2735
ISPAGHULA HUSK
DRY
A,H
When a dose for children is stated, the

label:
- (PSYLL) 'On medical advice' (or
2736
ISPAGHULA HUSK
POWDER
A,H

label:
2737
IVA AXILLARIS
A,H
2738
JAMAICA
DOGWOOD BARK
A,H
111
Schedule 1
DRY
2739
JAMAICA
DOGWOOD BARK
POWDER
A,H
2740
JASMINE ABSOLUTE

no more than 5%.
must be no more 1%.
2741
JASMINE LACTONE

dermal application.
2742
JASMINE OIL

fragrance.
2743
JASMINUM
GRANDIFLORUM

flavour.
no more than 5%.
2744
JASMINUM
OFFICINALE
A,E,H
2745
JASSOLIA

fragrance.
112
Schedule 1

2746
JATEORHIZA
PALMATA
A,H
2747
JATROPHA CURCAS
2748
JERUSALEM
ARTICHOKE
2749
JOJOBA ESTERS

homoeopathic ingredient

in the eye.
2750
JUGLANS CINEREA
A,E,H
2751
JUGLANS NIGRA
A,E,H
2752
JUGLANS REGIA
A,H
2753
JUNCUS EFFUSUS
A,H
2754
JUNIPER BERRY OIL
A,E,H
2755
JUNIPER BERRY OIL

TERPENELESS

fragrance.
2756
JUNIPERUS
CALIFORNICA
A,H
2757
JUNIPERUS
COMMUNIS
A,E,H
2758
JUNIPERUS
MEXICANA

fragrance.
113
Schedule 1

2759
JUNIPERUS
OXYCEDRUS
A,H
2760
JUNIPERUS
VIRGINIANA
A,E,H
2761
JUSTICIA
ADHATODA
A,H
114
Schedule 1
Column 1
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine

2762
KADSURA
COCCINEA
A,H
2763
KAEMPFERIA
GALANGA
A,H
2764
KALMIA LATIFOLIA
A,H
2765
KAOLIN
2766
KAOLIN - HEAVY
2767
KAOLIN - LIGHT
2768
KELP DRY
A,H

Kelp dry.
2769
KELP POWDER
A,E,H

Kelp powder.
Schedule 1

2770
KERATIN

in the eye.
2771
KEROSENE
E,H
Only for use as a homoeopathic

ingredient.
When used in liquid preparations, the
no more than 25%.
2772
KIDNEY BEAN
2773
KIRSCH

flavour.
no more than 5%.
2774
KIWI FRUIT
2775
KNAUTIA ARVENSIS
A,H
2776
KOREAN GINSENG
ROOT DRY
A,H
2777
KOREAN GINSENG
ROOT POWDER
A,H
2778
KRAMERIA IXIENA
A,H
Schedule 1
2779
KRAMERIA
LAPPACEA
A,H
2780
KUNZEA AMBIGUA
Only for use when the plant

preparation is essential oil.
administration is topical or inhalation.
When the dosage form is essential oil,
a restricted flow insert must be fitted
on the container and the medicine
children'
- (EXTERN) 'For external use only'
- (UNDILU) 'Not to be applied
undiluted to the skin except on the
advice of a health care practitioner'.
When the dosage form is other than
essential oil, the maximum
concentration in topical medicines
must be no more than 25% w/w and
the medicine requires the following
label:
children'
- (EXTERN) 'For external use only'.
2781
L-BORNEOL

no more than 5%.
Schedule 1
must be no more 1%.

2782
L-BORNYL ACETATE E

fragrance.
2783
L-CARVONE

no more than 5%.
must be no more 1%.
2784
L-LIMONENE

flavour.
no more than 5%.
must be no more 1%.
2785
L-LINALOOL

flavour.
no more than 5%.
2786
L-MENTHONE

Schedule 1

no more than 5%.
must be no more 1%.
2787
L-MENTHYL
ACETATE

no more than 5%.
must be no more 1%.
2788
L-ROSE OXIDE

no more than 5%.
must be no more 1%.
2789
LABDANUM
ABSOLUTE

fragrance.
2790
LABDANUM GUM
EXTRACT ETHYL
ESTER

fragrance.
If used in a fragrance and the total
is no more than 1%.
Schedule 1
2791
LABDANUM OIL
A,E,H
2792
LABURNUM
ANAGYROIDES
A,H
Sparteine is a mandatory component

of Laburnum anagyroides.
The concentration of sparteine in the
0.001%.
2793
LACTALBUMIN
2794
LACTIC ACID
A,E,H

of excipients containing alpha hydroxy
acids on the sensitivity of the skin to
sunlight and should ensure the finished
medicine is safe for its intended
purpose.
2795
LACTITOL
MONOHYDRATE

label:
- (SUGOLS) 'Medicines containing
lactitol monohydrate may have a
laxative effect or cause diarrhoea' (or
- (LACT) 'Contains lactose' (or words
to that effect)
- (COWMK) 'Derived from cows
milk'.
2796
LACTOBACILLUS
ACIDOPHILUS
2797
LACTOBACILLUS
AMYLOVORUS
Schedule 1
2798
LACTOBACILLUS
BREVIS
2799
LACTOBACILLUS
CASEI
2800
LACTOBACILLUS
CASEI SUBSP.
BIOVAR CASEI
2801
LACTOBACILLUS
CRISPATUS
2802
LACTOBACILLUS
DELBRUECKII SSP
BULGARICUS
2803
LACTOBACILLUS
DELBRUECKII SSP
LACTIS
2804
LACTOBACILLUS
FERMENTUM
2805
LACTOBACILLUS
GALLINARUM
2806
LACTOBACILLUS
GASSERI
2807
LACTOBACILLUS
HELVETICUS
2808
LACTOBACILLUS
JOHNSONII
2809
LACTOBACILLUS
KEFIRANOFACIENS
2810
LACTOBACILLUS
KEFIRGRANUM
2811
LACTOBACILLUS
KEFIRI
2812
LACTOBACILLUS
PARACASEI
Schedule 1
2813
LACTOBACILLUS
PARACASEI SUBSP.
PARACASEI
2814
LACTOBACILLUS
PLANTARUM
2815
LACTOBACILLUS
REUTERI
2816
LACTOBACILLUS
RHAMNOSUS
2817
LACTOBACILLUS
SALIVARIUS SSP
SALICINIUS
2818
LACTOBACILLUS
SALIVARIUS SSP
SALIVARIUS
2819
LACTOBIONIC ACID

dermal application.
2820
LACTOFERRIN BOVINE

label:
milk.'
2821
LACTOSCATONE

fragrance.
2822
LACTOSE

Schedule 1

label:
OR Contains sugars [or words to that
effect] if medicine contains two or
more sugars.
label:
- (LACT) Contains lactose [or words
to that effect].
2823
LACTOSE
MONOHYDRATE

invert sugar, lactose monohydrate,
maltose, and sucrose) is more than
100mg in the maximum daily dose,
then the medicine requires the
medicine label:
OR Contains sugars [or words to that
effect] if medicine contains two or
more sugars.
If one of the sugars is lactose
monohydrate then the medicine also
- (LACT) Contains lactose
monohydrate [or words to that effect].
2824
LACTUCA SATIVA
A,H
2825
LACTUCA VIROSA
A,H
Schedule 1
2826
LACTULOSE
2827
LACTULOSE
SOLUTION
2828
LAGENARIA
VULGARIS
A,H
2829
LAMINARIA
CLOUSTONI
A,E,H


Laminaria cloustoni.
2830
LAMINARIA
DIGITATA
A,E,H

Laminaria japonica and must be
declared in the application.
10
Schedule 1

2831
LAMINARIA
JAPONICA
A,E,H

Laminaria japonica.
2832
LAMIUM ALBUM
A,H
2833
LANETH-5
2834
LANOLIN HYDROXYLATED
2835
LANOLIN ALCOHOL

dermal application.
2836
LANOLIN OIL

dermal application.
2837
LANOLIN WAX

dermal application.
2838
LANTANA CAMARA
A,H

dose must contain no more than 1mg
of the equivalent dry herbal material of
Lantana camara.
2839
LARIX DECIDUA
A,H
2840
LARIX KAEMPFERI
A,H

dermal application.

dose must be no more than 1 mg of the
equivalent dry herbal material of Larix
11
Schedule 1
kaempferi.
2841
LARREA
TRIDENTATA
A,H

label:
- (CHAP) 'WARNING: Chaparral may
harm the liver in some people - use
only under supervision of a health care
professional'.
2842
LATHYRUS SATIVUS
A,H

equivalent dry herbal material of
Lathyrus sativus.
The medicine must not contain
lathyrogenic amino acids.
2843
LAURAMINE OXIDE
2844
LAUREL LEAF OIL
A,H
2845
LAURETH-10

dermal application.
2846
LAURETH-12

dermal application.
2847
LAURETH-2

in the eye.
Residual levels of ethylene oxide (and
related substances) must be kept below
the level of detection.
2848
LAURETH-23

dermal application.
2849
LAURETH-3

dermal application.
12
Schedule 1
2850
LAURETH-4

dermal application.
2851
LAURETH-7

dermal application.
2852
LAURETH-8
2853
LAURIC ACID
A,E
When for use as an active ingredient is

for use in oral medicines only and the
must not exceed 1500 mg.
2854
LAURIL MACROGOL
400 DIMETICONE

2855
LAUROMACROGOL
400

dermal application.
2856
LAUROYL LYSINE

in the eye.
2857
LAURUS NOBILIS
A,E,H
2858
LAURYL ALDEHYDE

coating solution, flavour or a
fragrance.
no more than 5%.
must be no more 1%.
13
Schedule 1
2859
LAURYL BETAINE

dermal application.
2860
LAURYL
GLUCOSIDE

the eye.
2861
LAURYL LACTATE

in the eye.
of excipients containing alpha hydroxy
acids on the sensitivity of the skin to
sunlight and should ensure the finished
medicine is safe for its intended
purpose.
2862
LAURYL PCA

in the eye.
2863
LAURYL PEG-10
TRIS(TRIMETHYLSIL
OXY)SILYLETHYL
DIMETICONE

2864
LAURYL PEG-9
POLYDIMETHYLSIL
OXYETHYL

14
Schedule 1
DIMETICONE
in the eye.
2865
LAURYL PEG/PPG18/18 METHICONE

in the eye.
Residual levels of ethylene oxide (and
related substances) must be kept below
the level of detection.
2866
LAURYL
POLYGLUCOSE

in the eye.
The concentration must not exceed 1%
in leave-on medicines and 3% in
wash-on/wash-off medicines.
2867
LAURYL
PYRROLIDONE

dermal application.
2868
LAURYLDIMONIUM
HYDROXYPROPYL
HYDROLYSED
COLLAGEN

dermal application.
2869
LAURYLDIMONIUM
HYDROXYPROPYL
HYDROLYSED SOY
PROTEIN

in the eye.
2870
LAURYLMETICONE
COPOLYOL

dermal application.
2871
LAVANDIN OIL

15
Schedule 1
no more than 5%.
must be no more 1%.
2872
LAVANDIN OIL
ABRIAL
A,E,H
2873
LAVANDIN OIL
GROSSO

fragrance.
2874
LAVANDULA
ANGUSTIFOLIA
A,E,H
Camphor is a mandatory component of

Lavandula angustifolia.
no more than 12.5%.
children (or word to that effect)
16
Schedule 1

label:
2875
LAVANDULA
ANGUSTIFOLIA
SUBSP.
ANGUSTIFOLIA
A,E,H
2876
LAVANDULA X
INTERMEDIA
A,E,H

Lavandula x intermedia.
no more than 12.5%.
17
Schedule 1

label:
2877
LAVENDER OIL
A,E,H

Lavender Oil.
18
Schedule 1

no more than 12.5%.
19
Schedule 1
label:
2878
LAWSONIA INERMIS
A,H
2879
LEAD

2880
LEAD ACETATE

2881
LEAF ACETAL

flavour.
no more than 5%.
2882
LECITHIN
A,E
2883
LECITHIN - EGG
A,E
2884
LECITHIN HYDROGENATED

in the eye.
2885
2886
LECITHIN LIQUID SOY

PHOSPHATIDYLSERI
NE-ENRICHED SOY
LECITHIN POWDER SOY
Soy phosphatidylserine is a mandatory

component of Lecithin liquid - soy
phosphatidylserine-enriched soy.
The concentration of soy
phosphatidylserine in the medicine
Soy phosphatidylserine is a mandatory
component of Lecithin powder - soy
20
Schedule 1
PHOSPHATIDYLSERI
NE-ENRICHED SOY
phosphatidylserine-enriched soy.
The concentration of soy
phosphatidylserine in the medicine
2887
LEDEBOURIELLA
SESELOIDES
A,H
2888
LEDUM
GROENLANDICUM
A,H
2889
LEDUM PALUSTRE
A,H
2890
LEMNA MINOR
A,H
2891
LEMON
2892
LEMON BALM LEAF

DRY
A,H
2893
LEMON BALM LEAF

POWDER
A,E,H
2894
LEMON OIL
A,E,H

other than topical, the maximum
more than 0.001mg of the equivalent
dry herbal material of Ledum palustre.
When Oxedrine is a component of

Lemon, the maximum recommended
daily dose must provide no more than
30 mg of Oxedrine.
For use in oral medicines or in soaps

or bath and shower gels that are
washed off the skin.
When for topical use, the medicine
The concentration of Lemon oil in the
When for internal use oxedrine is a
21
Schedule 1
component of Lemon Oil, the

must provide no more than 30 mg of
Oxedrine.
2895
LEMON OIL
DISTILLED
A,E,H

Lemon Oil Distilled, the maximum
recommended daily dose must provide
no more than 30 mg of Oxedrine.
2896
LEMON OIL
TERPENELESS
A,E,H
When oxedrine is a component of

Lemon Oil Terpeneless, the maximum
no more than 30 mg of oxedrine.
2897
LEMON OIL
TERPENES AND
TERPENOIDS

no more than 5%.
must be no more 1%.
2898
LEMON PEEL DRIED
A,E,H
2899
LEMONGRASS OIL
A,E,H
2900
LENS CULINARIS
A,H
2901
LENTIL
2902
LENTINULA EDODES
A,E,H
2903
LEONTOPODIUM
ALPINUM

Lemon Peel Dried, the maximum

in the eye.
22
Schedule 1

2904
LEONURUS
CARDIACA
A,E,H
2905
LEONURUS
SIBIRICUS
A,E,H
2906
LEPIDIUM
APETALUM
A,H
2907
LEPIDIUM MEYENII
Only for use in oral medicines when

the plant part is tuber and the plant
preparation is dry.
dose must be no more than 3.5g of
Lepidium meyenii dried tuber (or its
extract equivalent).
2908
LEPTOSPERMUM
PETERSONII

dermal application.
must be no more 5%.
2909
LEPTOSPERMUM
SCOPARIUM OIL
Only for use as an active ingredient

topical or oral application in a
mouthwash preparation.
If the concentration is more than 25%,
must be no more than 25mL.
When the concentration is more than
container less than 15mL, a restricted
label:
23
Schedule 1

When the concentration is more than
be fitted on the container and requires
the medicine label:
2910
LESPEDEZA
CAPITATA
A,H
2911
LETTUCE
2912
LEUCINE
A,E
2913
LEUZEA
UNIFLORUM
A,H
2914
LEVISTICUM
OFFICINALE
A,H
2915
LEVOCARNITINE
2916
LEVOCARNITINE
FUMARATE
2917
LEVOCARNITINE
HYDROCHLORIDE
2918
LEVOCARNITINE
MAGNESIUM
CITRATE
2919
LEVOCARNITINE
TARTRATE
2920
LEVOMEFOLATE
CALCIUM
A,H

Levomefolic acid is a mandatory
24
Schedule 1
component of Levomefolate calcium.

dose must provide no more than
500mcg of Levomefolic acid from
Levomefolate calcium.
When used in combination with folic
acid, folinic acid and/or their
derivatives, the medicine must not
provide more than a total of 500 mcg
of folic acid, folinic acid and/or their
derivatives in total per maximum
The following indication is only
oral use and the required warning
statement Do not exceed the stated
dose except on medical advice. If you
have had a baby with a neural tube
defect/spina bifida - seek specific
medical advice (or words to that
effect) is included on the medicine
label.
- Provides a minimum daily dose of
400-500micrograms of folic acid or
folate. If taken daily when trying to
conceive and during the first trimester
of pregnancy and/or for at least four
weeks before conception and during
the first trimester of pregnancy, folic
acid may help to prevent neural tube
defects such as spina bifida and/or
anencephaly. [Warning NEUR
required]
2921
LEVOMEFOLATE
GLUCOSAMINE

Levomefolic acid is a mandatory
component of Levomefolate
glucosamine.
25
Schedule 1
500mcg of Levomefolic acid from

Levomefolate glucosamine.
When used in combination with folic
acid, folinic acid and/or their
derivatives, the medicine must not
provide more than a total of 500 mcg
of folic acid, folinic acid and/or their
derivatives in total per maximum
The following indication is only
oral use and the required warning
statement Do not exceed the stated
dose except on medical advice. If you
have had a baby with a neural tube
defect/spina bifida - seek specific
medical advice (or words to that
effect) is included on the medicine
label.
- Provides a minimum daily dose of
400-500 micrograms of folic acid or
folate. If taken daily when trying to
conceive and during the first trimester
of pregnancy and/or for at least four
weeks before conception and during
the first trimester of pregnancy, folic
acid may help to prevent neural tube
defects such as spina bifida and/or
anencephaly. [Warning NEUR
required]
2922
LEVOTHYROXINE
SODIUM

2923
LEVULINIC ACID

flavour.
no more than 5%.
26
Schedule 1
2924
LIGUSTICUM
SINENSE
A,H
2925
LIGUSTICUM
WALLICHII
A,E,H
2926
LIGUSTRUM
LUCIDUM
A,H
2927
LILIUM BROWNII
A,H
2928
LILIUM CANDIDUM
A,E,H
2929
LILIUM
LANCIFOLIUM
A,H
2930
LILIUM
LONGIFLORUM
A,H
2931
LIME FRUIT
2932
LIME OIL

no more than 5%.
must be no more 1%.
2933
LIME OIL
COLDPRESSED
A,E,H
Only for use in medicine for internal

use or for use in soaps or bath and
shower gels that are washed off the
skin.
must be no more than 0.5 %.
label:
27
Schedule 1

2934
LIME OIL DISTILLED
A,E,H
2935
LIME OIL
TERPENELESS

flavour.
no more than 5%.
2936
LIME OIL TERPENES

AND TERPENOIDS

no more than 5%.
must be no more 1%.
2937
LIME TREE FLOWER

DRY
A,H
2938
LIME TREE FLOWER

POWDER
A,H
2939
LIME, ESSENCE
2940
LIMES TERPENES

fragrance.
2941
LIMONENE
When for oral use, the quantity must

be no more than 10 mg per maximum
2942
LINALOOL

dermal application.
28
Schedule 1
2943
LINALOOL OXIDE

no more than 5%.
must be no more 1%.
2944
LINALYL ACETAL

no more than 5%.
must be no more 1%.
2945
LINALYL ACETATE
2946
LINALYL BENZOATE E

dermal application.
flavour.
no more than 5%.
2947
LINALYL
BUTYRATE

fragrance.
2948
LINALYL
CINNAMATE

fragrance.
29
Schedule 1

2949
LINALYL FORMATE

no more than 5%.
must be no more 1%.
2950
LINALYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
2951
LINALYL
PROPIONATE

no more than 5%.
must be no more 1%.
2952
LINDERA
STRYCHNIFOLIA
A,H
2953
LINOLEAMIDOPROP
YL PG-DIMONIUM
CHLORIDE

30
Schedule 1
PHOSPHATE
in the eye.
2954
LINOLEIC ACID
2955
LINOLENIC ACID
2956
LINSEED DRY
A,E,H
2957
LINSEED OIL
A,E,H
2958
LINSEED POWDER
A,E,H
2959
LINUM
USITATISSIMUM
A,E,H
2960
LIPASE
Lipase must only be derived from

Rhizopus oryzae and must comply
with the relevant compositional
guideline
When used in an undvided
preparation, the unit 'Thousand lipase
units per gram' is permitted.
When used in a divuded preparation,
the unit 'Thousand lipase unit' is
permitted.
2961
LIQUIDAMBAR
FORMOSANA
A,H
2962
LIQUIDAMBAR
ORIENTALIS
A,H
2963
LIQUIDAMBAR
STYRACIFLUA
A,E,H
2964
LIQUIDAMBAR
TAIWANIANA
A,H
2965
LIQUIDAMBER
STYRACIFLUA
RESIN

fragrance.
31
Schedule 1

2966
LIQUORICE

flavour.
no more than 5%.
2967
LIQUORICE DRY
A,E,H
2968
LIQUORICE LIQUID
EXTRACT
A,E,H
2969
LIQUORICE POWDER
A,E,H
2970
LITCHI CHINENSIS
A,H
2971
LITHIUM
CARBONATE

2972
LITHOSPERMUM
OFFICINALE
A,H

Lithospermum officinale.
2973
LITSEA CUBEBA
A,E,H
2974
LITSEA CUBEBA OIL

no more than 5%.
must be no more 1%.
2975
LOBARIA
PULMONARIA
A,H
2976
LOBELIA DRY
A,H

must be no more than 0.001% or
10mg/kg or 10ml/L or 10 ppm unless
32
Schedule 1
the medicine is administered by

inhalation.
2977
LOBELIA INFLATA
A,H

inhalation.
2978
LOBELIA POWDER
A,H

inhalation.
2979
LOLIUM PERENNE
A,H
2980
LOLIUM
TEMULENTUM
A,H
2981
LONGIFOLENE

fragrance.
longifolene concentration in a
2982
LONICERA
CAPRIFOLIUM
A,E,H
2983
LONICERA
JAPONICA
A,E,H
2984
LONICERA
PERICLYMENUM
A,H
2985
LOPHATHERUM
GRACILE
A,H
2986
LOQUAT
2987
LORANTHUS
PARASITICUS
A,H
2988
LOROPETALUM
CHINENSIS
A,H
33
Schedule 1
2989
LOTUS
CORNICULATUS
A,H
2990
LOVAGE EXTRACT

flavour.
no more than 5%.
2991
LOVAGE OIL
A,E,H
2992
LOVAGE ROOT DRY
A,H
2993
LOVAGE ROOT
POWDER
A,H
2994
LUDWIGIA
PROSTRATA
A,H
2995
LUFFA CYLINDRICA
A,H
2996
LUFFA PURGANS
A,H
2997
LUTEIN
A,E,H
2998
LYCHEE
2999
LYCIUM
BARBARUM
A,H
3000
LYCIUM CHINENSE
A,E,H
3001
LYCOPENE
A,E
3002
LYCOPERSICON
ESCULENTUM
A,E,H

and topical use.
Steroidal alkaloids calculated as

solanine is a mandatory component of
Lycopersicon esculentum.
The maximum daily dose must not
provide more than 10 mg of steroidal
alkaloids calculated as solanine.
3003
LYCOPODIUM
ANNOTINUM
A,H
34
Schedule 1
3004
LYCOPODIUM
CLAVATUM
A,H
3005
LYCOPODIUM
COMPLANATUM
A,H
3006
LYCOPUS
EUROPAEUS
A,H
3007
LYCOPUS LUCIDUS
A,H
3008
LYCOPUS
VIRGINICUS
A,H

Lycopus virginicus.
3009
LYGODIUM
JAPONICUM
A,H
3010
LYSIMACHIA
CHRISTINAE
A,H
3011
LYSIMACHIA
VULGARIS
A,H
3012
LYSINE
A,E
3013
LYSINE
HYDROCHLORIDE
A,E
3014
LYTHRUM
HYSSOPIFOLIA
A,H
3015
LYTHRUM
SALICARIA
A,H
3016
LYTHRUM
VERTICILLATUM
A,H
3017
MACADAMIA
INTEGRIFOLIA
A,E
3018
MACADAMIA NUT
3019
MACADAMIA NUT
OIL
35
Schedule 1
3020
MACADAMIA
TERNIFOLIA
A,E,H
3021
MACE
E,H

Safrole is a mandatory component of
Mace.
When used internally, the
When used topically, the concentration
of safrole in the medicine must be no
more than 1.0%.
3022
MACE OIL
A,H

Mace oil.
When used internally, the
of safrole in the medicine must be no
more than 1.0%.
When the concentration of mace oil in
is 25 mL or less, a restricted flow
3023
MACROCYSTIS
PYRIFERA
A,E,H

Macrocystis pyrifera.
36
Schedule 1

3024
MACROGOL 1000
3025
MACROGOL 1450
3026
MACROGOL 1500
3027
MACROGOL 1500
CASTOR OIL

dermal application.

3028
MACROGOL 200

dermal application.
3029
MACROGOL 20000
3030
MACROGOL 300
3031
MACROGOL 3000
3032
MACROGOL 3350
A,E

3033
MACROGOL 40

dermal application.
3034
MACROGOL 400
3035
MACROGOL 4000
3036
MACROGOL 45000
3037
MACROGOL 600

dermal application.
37
Schedule 1
3038
MACROGOL 6000
3039
MACROGOL 600000
3040
MACROGOL 800
3041
MACROGOL 8000
3042
MACROGOL 900

in the eye.
3043
3044
MACROGOL
POLY(VINYL
ALCOHOL)
GRAFTED POLYMER
MAGNESIUM AMINO
ACID CHELATE
A,E,H

The purpose for use for all metal
amino acid chelates is restricted to
mineral supplementation.
supplementation, magnesium is a
mandatory component of Magnesium
amino acid chelate.
The quantity of magnesium in the
3045
MAGNESIUM
ASCORBATE
A,E,H

medicine label:
38
Schedule 1

balanced diet.
3046
MAGNESIUM
ASCORBATE
MONOHYDRATE
A,E,H

medicine label:
balanced diet.
3047
MAGNESIUM
ASCORBYL
PHOSPHATE

dermal application.
3048
MAGNESIUM
ASPARTATE
A,E,H

mandatory component of magnesium
aspartate tetrahydrate.
The percentage of Magnesium from
magnesium aspartate tetrahydrate
molecular weight of magnesium
39
Schedule 1

oral or sublingual use.3049
MAGNESIUM
ASPARTATE
DIHYDRATE
A,E,H

aspartate dihydrate. The percentage of
magnesium from magnesium aspartate
dihydrate should be calculated based
on the molecular weight of magnesium
aspartate dihydrate. The indication
For mineral (may state the mineral)
supplementation is only permitted
when the medicine is for oral or
sublingual use.
3050
MAGNESIUM
ASPARTATE
TETRAHYDRATE
A,E,H

magnesium aspartate tetrahydrate
3051
MAGNESIUM
CARBONATE
HYDRATE
A,E,H

carbonate hydrate.
The amount of magnesium in the
active ingredient should be calculated
magnesium carbonate hydrate.
40
Schedule 1

3052
MAGNESIUM
CHLORIDE 4.5HYDRATE

chloride 4.5-hydrate.
The percentage of magnesium from
magnesium chloride 4.5-hydrate
chloride 4.5-hydrate.
3053
MAGNESIUM
CHLORIDE
HEXAHYDRATE
A,E,H

magnesium chloride hexahydrate
3054
MAGNESIUM
CITRATE
A,E,H

citrate.
magnesium citrate should be
41
Schedule 1

weight of magnesium citrate.
3055
MAGNESIUM
CITRATE - DIBASIC
TETRAHYDRATE

citrate - dibasic tetrahydrate.
Magnesium citrate - dibasic
tetrahydrate should be calculated
Magnesium citrate - dibasic
tetrahydrate.
3056
MAGNESIUM
CITRATE
NONAHYDRATE
A,E,H

citrate nonahydrate.
magnesium citrate nonahydrate should
weight of magnesium citrate
nonahydrate.
3057
MAGNESIUM
A,E,H
42
Schedule 1
CITRATE
TETRADECAHYDRA
TE

citrate tetradecahydrate.
magnesium citrate tetradecahydrate
molecular weight of magnesium citrate
tetradecahydrate.
3058
MAGNESIUM
DIGLUTAMATE
A,E,H

3059
MAGNESIUM
GLUCONATE
A,E,H

gluconate.
magnesium gluconate should be
weight of magnesium gluconate.
3060
MAGNESIUM
GLYCEROPHOSPHA
TE
A,E,H

glycerophosphate.
magnesium glycerophosphate should
43
Schedule 1
weight of magnesium
glycerophosphate.
3061
MAGNESIUM
GLYCINATE

Magnesium is a mandatory component
of Magnesium glycinate.
Magnesium glycinate should be
weight of Magnesium glycinate
3062
MAGNESIUM
GLYCINATE
DIHYDRATE

of Magnesium glycinate dihydrate.
declared quantity of Magnesium from
Magnesium glycinate dihydrate must
be no less than 11.1% and must be no
more than 12.2% of th eMagnesium
glycinate dihydrate in the formulation.
calculations.
44
Schedule 1
3063
MAGNESIUM
HYDROGEN
PHOSPHATE
3064
MAGNESIUM
HYDROXIDE
A,E

3065
MAGNESIUM
LYSINATE

mineral supplementation. Magnesium
is a mandatory component of
Magnesium lysinate.
Magnesium lysinate should be
weight of Magnesium lysinate.
3066
MAGNESIUM
METHIONINATE

of magnesium methioninate.
magnesium methioninate should be
weight of magnesium methioninate.
45
Schedule 1

3067
MAGNESIUM
NITRATE

dermal application.
3068
MAGNESIUM
OROTATE
A,E,H

orotate .
Magnesium orotate should be
weight of Magnesium orotate.
3069
MAGNESIUM
OROTATE
DIHYDRATE
A,E,H

orotate dihydrate.
magnesium orotate dihydrate should
weight of magnesium orotate
dihydrate.
3070
MAGNESIUM OXIDE
A,E,H

oxide.
Magnesium oxide should be calculated
46
Schedule 1

Magnesium oxide.
3071
MAGNESIUM OXIDE
- HEAVY
A,E,H

oxide - heavy.
Magnesium oxide heavy should be
weight of Magnesium oxide heavy.
3072
MAGNESIUM OXIDE
- LIGHT
A,E,H

oxide - light.
Magnesium oxide - light should be
weight of Magnesium oxide - light.
3073
MAGNESIUM
PHOSPHATE DIBASIC
TRIHYDRATE
A,E,H

of Magnesium phosphate - dibasic
trihydrate.
accepted percentage of Magnesium
47
Schedule 1
from Magnesium phosphate - dibasic

trihydrate is 13.9%. The declared
quantity of Magnesium from
Magnesium phosphate - dibasic
trihydrate must be no less than 13.2%
the Magnesium phosphate - dibasic
trihydrate in the formulation. These
3074
MAGNESIUM
PHOSPHATE
PENTAHYDRATE
A,E,H

phosphate pentahydrate.
The amount of magnesium in the
magnesium phosphate pentahydrate.
3075
3076
MAGNESIUM
PHOSPHATE
TRIBASIC
A,E,H
MAGNESIUM
PYRUVATE

of magnesium phosphate tribasic.
accepted percentage of Magnesium
from magnesium phosphate tribasic is
Magnesium from magnesium
phosphate tribasic must be no less than
29.1% of the magnesium phosphate
tribasic in the formulation. These
48
Schedule 1
dose must be no more than 7 grams.

pyruvate.
magnesium pyruvate should be
weight of pyruvate.
3077
MAGNESIUM
STEARATE
3078
MAGNESIUM
SULFATE - DRIED
A,E,H
When used internally, the maximum

more than 1.5g.
sulfate - dried.
Magnesium sulfate - dried should be
weight of Magnesium sulfate - dried.
3079
MAGNESIUM
SULFATE
DIHYDRATE
A,E,H

more than 1.5g.
49
Schedule 1
mineral supplementation, magnesium

Magnesium sulfate dihydrate.
Magnesium sulfate dihydrate should
weight of Magnesium sulfate
dihydrate.
3080
MAGNESIUM
SULFATE
HEPTAHYDRATE
A,E,H

more than 1.5g.
mineral supplementation, magnesium
magnesium sulfate heptahydrate.
magnesium sulfate heptahydrate
sulfate heptahydrate.
3081
MAGNESIUM
SULFATE
MONOHYDRATE
A,E,H

more than 1.5g.
50
Schedule 1

Magnesium sulfate monohydrate
molecular weight of Magnesium
3082
MAGNESIUM
SULFATE
TRIHYDRATE
A,E,H

more than 1.5g.
sulfate trihydrate.
Magnesium sulfate trihydrate should
weight of Magnesium sulfate
trihydrate.
3083
MAGNESIUM
TRISILICATE
3084
MAGNOLIA GLAUCA
A,H
3085
MAGNOLIA
LILIFLORA
A,H
3086
MAGNOLIA
OBOVATA
A,H
3087
MAGNOLIA
OFFICINALIS
A,E,H
51
Schedule 1
3088
MAGNOLIA
SALICIFOLIA
A,H
3089
MAIZE
3090
MAIZE BRAN
3091
MAIZE OIL
A,E,H
3092
MAIZE SYRUP HIGH FRUCTOSE

flavour.
no more than 5%.
3093
MALACHITE GREEN

topical use.
3094
MALIC ACID

of excipients on the sensitivity of the
skin to sunlight and should ensure the
finished medicine is safe for its
intended purpose.
3095
MALPIGHIA
GLABRA
A,E,H
3096
MALT EXTRACT
3097
MALTITOL

medicine label:
3098
MALTITOL
SOLUTION

52
Schedule 1

medicine label:
[insert name of sugar alcohol(s)] may
diarrhoea' (or words to that effect).
3099
MALTODEXTRIN

Maltodextrin where the ingredient is
derived from gluten containing grains
such as wheat, barley, rye and oats.
label:
ingredient]' (or words to that effect).
3100
MALTOL
3101
MALTONE

flavour.
no more than 5%.
3102
MALTOSE

label:
53
Schedule 1

more sugars.
label:
to that effect).
3103
MALUS DOMESTICA
A,E,H
3104
MALUS PUMILA
A,E,H
3105
MALUS SYLVESTRIS
A,H
3106
MALVA MOSCHATA
A,H
3107
MALVA SYLVESTRIS
A,E,H
3108
MALVA
VERTICILLATA
A,H
3109
MANDARIN
3110
MANDARIN OIL
The concentration of amygdalin in the


no more than 5%.
must be no more 1%.
3111
MANDARIN OIL
COLDPRESSED
A,E,H

Mandarin oil coldpressed, the
Oxedrine.
54
Schedule 1
3112
MANDARIN OIL
TERPENES

no more than 5%.
must be no more 1%.
3113
MANDARIN
RESIDUE

flavour.
no more than 5%.
3114
MANDARINAL 32048

fragrance.
3115
MANDRAGORA
OFFICINARUM
A,H
Atropine, hyoscine and hyoscyamine

Mandragora officinarum.
must be no more than 10 mg/kg or 10
mL/L or 0.001%.
or 0.00001%.
or 0.00003%.
The concentration of hyoscyamine in
55
Schedule 1

3116
MANGANESE

3117
MANGANESE (II)
DIASPARTATE
A,H

Manganese is a mandatory component
of Manganese (II) diaspartate.
The percentage of Manganese from
Manganese (II) diaspartate should be
weight of Manganese (II) diaspartate.
3118
MANGANESE (II)
GLYCINATE
A,H

Manganese is a mandatory component
of Manganese (II) glycinate.
Manganese (II) glycinate should be
weight of Manganese (II) glycinate.
3119
MANGANESE
ACETATE

56
Schedule 1
TETRAHYDRATE
3120
MANGANESE
AMINO ACID
CHELATE
A,E,H

supplementation, the equivalent
quantity of Manganese.
The declared quantity of Manganese
Manganese amino acid chelate in the
formulation.
3121
MANGANESE
CHLORIDE
TETRAHYDRATE
A,E,H

supplementation, manganese is a
mandatory component of manganese
chloride tetrahydrate.
The percentage of manganese from
manganese chloride tetrahydrate
molecular weight of manganese
chloride tetrahydrate.
3122
MANGANESE
DIASPARTATE
A,E,H

57
Schedule 1

supplementation, the equivalent
quantity of Manganese is required.
The declared quantity of Manganese
manganese diaspartate in the
formulation.
3123
MANGANESE
GLUCONATE
A,E,H

supplementation, Manganese is a
mandatory component of Manganese
gluconate.
Manganese gluconate should be
weight of Manganese gluconate.
3124
MANGANESE
GLYCEROPHOSPHA
TE
A,E,H

mineral supplementation, Manganese
Manganese glycerophosphate.
Manganese glycerophosphate should
weight of Manganese
glycerophosphate.
58
Schedule 1

3125
MANGANESE OXIDE
A,E,H

supplementation, Manganese is a
oxide.
Manganese oxide should be calculated
Manganese oxide.
3126
MANGANESE
SULFATE
MONOHYDRATE
A,E,H

The percentage of manganese from
Manganese sulfate monohydrate
molecular weight of Manganese
3127
MANGANESE
SULFATE
TETRAHYDRATE
A,E,H

mandatory component of manganese
sulfate tetrahydrate. The percentage of
manganese from manganese sulfate
tetrahydrate should be calculated
manganese sulfate tetrahydrate.
59
Schedule 1

3128
MANGIFERA INDICA
A,E,H
3129
MANGO
E,H
3130
MANIHOT
UTILISSIMA
A,H
3131
MANNITOL

medicine label:
3132
MARANTA
ARUNDINACEA
A,H
3133
MARJORAM OIL
SPANISH
A,E,H

be no more than 50 mL, the medicine
must have a restricted flow insert fitted
to the container and requires the
medicine label:
3134
MARJORAM OIL
SWEET
A,E,H

to the container and requires the
60
Schedule 1
medicine label:
3135
MARRUBIUM
VULGARE
A,E,H
3136
MARSDENIA
CUNDURANGO
A,H
3137
MARSHMALLOW
ROOT DRY
A,H
3138
MARSHMALLOW
ROOT POWDER
A,H
3139
MARTYNIA
PARVIFLORA
A,H
3140
MASSOIA LACTONE

flavour.
no more than 5%.
3141
MASTIC
A,H
3142
MATE ABSOLUTE

no more than 5%.
must be no more 1%.
3143
MATRICARIA
CHAMOMILLA
A,E,H
3144
MATRICARIA
FLOWER DRY
A,E,H
61
Schedule 1
3145
MATRICARIA
RECUTITA
A,E,H
3146
MEADOWSWEET
HERB DRY
A,H
3147
MEADOWSWEET
HERB POWDER
A,H
3148
MECOBALAMIN (CO- A
METHYLCOBALAMI
N)
3149
MEDICAGO SATIVA
The level of l-canavanine must be no

more than that of the dried leaf.
A,E,H
When fresh leaf extract is used and the

extraction ratio is between 34:1 and
46:1, the quantity of l-canavanine in
the extract must not be more than that
in the fresh leaf.
3150
MEDIUM CHAIN
TRIGLYCERIDES
3151
MELALEUCA
ALTERNIFOLIA
A,E,H
Melaleuca oil, cajuput oil and cineole

Melaleuca alternifolia.
the concentration of Melaleuca oil,
cajuput oil or cineole in the medicine
is more than 25%, the nominal
capacity of the container must be no
more than 25 mL and the medicine
- (NTAKEN) Not to be taken.
When the nominal capacity of the
container is 15 mL or less, then a
62
Schedule 1
the container.
Where the nominal capacity of the
than or equal to 25 mL, then a child
3152
MELALEUCA
CAJUPUTI
A,E,H
Cineole, melaleuca oil and cajuput oil

are a mandatory components of
Melaleuca cajuputi.
the concentration of Cineole,
melaleuca oil or cajuput oil in the
be no more than 25 mL and the
label:
the container.
3153
MELALEUCA
DISSITIFLORA
A,H

Melaleuca dissitiflora.
63
Schedule 1

label:
the container.
3154
MELALEUCA
ERICIFOLIA
A,E,H

Melaleuca ericifolia.
label:
the container.
64
Schedule 1

3155
MELALEUCA
LINARIIFOLIA
A,H

Melaleuca linariifolia.
label:
the container.
3156
MELALEUCA OIL
A,E,H
Cineole and cajuput oil are a

mandatory components of Melaleuca
Oil.
25 mL and the medicine requires the
65
Schedule 1
medicine label:
the container.
3157
MELALEUCA
QUINQUENERVIA
A,E,H

Melaleuca quinquenervia.
label:
the container.
66
Schedule 1

3158
MELICOPE
PTELEIFOLIA
A,H
3159
MELILOTUS
OFFICINALIS
A,E,H
Coumarin is a mandatory component

of Melilotus officinalis.
The concentration of coumarin in the
0.001%.
3160
MELISSA
OFFICINALIS
A,E,H
3161
MELON
3162
MENADIONE
SODIUM BISULFITE
3163
MENAQUINONE 7
For oral use only.

The medicine must not provide more
than 180 micrograms per maximum
daily dose in adults, 90 micrograms
per maximum daily dose in children
between 10-18 years, and 45
micrograms per maximum daily dose
in children less than 10 years of age.
3164
MENISPERMUM
CANADENSE
A,H
3165
MENTHA AQUATICA
A,H
3166
MENTHA ARVENSIS
A,E,H
3167
MENTHA ARVENSIS
LEAF OIL

no more than 5%.
67
Schedule 1

3168
MENTHA ARVENSIS
OIL

flavour.
no more than 5%.
3169
MENTHA
HAPLOCALYX
A,E,H
3170
MENTHA PULEGIUM
A,H
D-Pulegone and volatile oil

components (of Mentha pulegium) are
mandatory components of Mentha
pulegium.
container is more than 15 mL, the
concentration of D-pulegone in the
When the concentration of D-Pulegone
in the preparation is more than 4% and
is 15 mL or less, the medicine must
medicine label:
When the medicine is for topical use,
Mentha pulegium oil.
When the medicine is for a use other
than topical, the maximum
more than 50 mg of Mentha pulegium
68
Schedule 1
oil.
3171
MENTHA SPICATA
A,E,H
3172
MENTHA X
CARDIACA
A,E,H
3173
MENTHA X
PIPERITA
A,E,H
3174
MENTHA X
PIPERITA
NOTHOSUBSP.
CITRATA
A,H
3175
MENTHADIENYL
ACETATE

flavour.
no more than 5%.
3176
MENTHANYL
ACETATE

fragrance.
3177
MENTHOFURAN

flavour.
no more than 5%.
3178
MENTHOL
A,E

permitted only in medicated space
sprays and medicated lozenges.
3179
MENTHONE

69
Schedule 1

no more than 5%.
must be no more 1%.
3180
MENTHONE
E
GLYCERINE ACETAL

flavour.
no more than 5%.
3181
MENTHONE THIOL
FRACTION

flavour.
no more than 5%.
3182
3183
MENTHOXYPROPAN
EDIOL
MENTHYL 2HYDROXYETHYL
CARBONATE
For oral use only.

flavour.
no more than 5%.
3184
MENTHYL 2HYDROXYPROPYL
CARBONATE

flavour.
no more than 5%.
3185
MENTHYL

70
Schedule 1
ANTHRANILATE

in the eye.
3186
MENTHYL
ISOVALERATE

flavour.
no more than 5%.
3187
MENTHYL LACTATE
3188
MENYANTHES
TRIFOLIATA
A,H
3189
MERCURIC
CHLORIDE

3190
MERCURIC IODIDE RED

3191
MERCURY

3192
MERCURY HAHNEMANN'S
SOLUBLE

3193
MESPILUS
GERMANICA
A,H
3194
METACRESOL

dermal application.
3195
METHACRYLIC
ACID COPOLYMER
3196
METHANOL
The residual solvent limit is 30 mg per

71
Schedule 1
3197
METHICONE

in the eye.
3198
METHIONINE
A,E
3199
METHYL-3METHYLTHIOPROPI
ONATE

flavour.
no more than 5%.
3200
METHYL-BETAMETHYL
THIOLPROPIONATE

flavour.
no more than 5%.
3201
METHYL-PARATERT-BUTYL
PHENYLACETATE

flavour.
no more than 5%.
3202
METHYL 2METHYLBUTYRATE

no more than 5%.
must be no more 1%.
72
Schedule 1
3203
METHYL 2OCTYNOATE

no more than 5%.
must be no more 1%.
3204
METHYL 3,6DIMETHYLRESORCY
LATE

fragrance.
3205
METHYL ACETATE

3206
METHYL
ACETOPHENONE

no more than 5%.
must be no more 1%.
3207
METHYL ACETYL
RICINOLEATE

dermal application.
3208
METHYL ANISATE

fragrance.
73
Schedule 1

3209
METHYL
ANTHRANILATE

no more than 5%.
must be no more 1%.
3210
METHYL BENZOATE

dermal application.
3211
METHYL BUTYRATE

flavour.
no more than 5%.
3212
METHYL CAPROATE

flavour.
no more than 5%.
3213
METHYL
CAPRYLATE

no more than 5%.
must be no more 1%.
3214
METHYL CARBITOL

74
Schedule 1
fragrance.
3215
METHYL CEDRYL
KETONE

fragrance.
3216
METHYL
CINNAMATE

no more than 5%.
must be no more 1%.
3217
METHYL CIS-5OCTENOATE

flavour.
no more than 5%.
3218
METHYL
CYCLOPENTENOLO
NE

no more than 5%.
must be no more 1%.
3219
METHYL
75
Schedule 1
CYCLOPENTYLIDEN
EACETATE

fragrance.
3220
3221
METHYL DI-TERTBUTYL-4HYDROXYHYDROCI
NNAMATE
METHYL
DIHYDROABIETATE

fragrance.
fragrance.
3222
METHYL
DIISOPROPYL
PROPIONAMIDE

flavour.
no more than 5%.
3223
METHYL ETHER

dermal application.
3224
METHYL ETHYL
KETONE

maximum recommended daily dose.
3225
METHYL EUGENOL

76
Schedule 1
no more than 5%.

must be no more 1%.
3226
METHYL FUROATE

flavour.
no more than 5%.
3227
METHYL GLUCETH10

in the eye.
Residue levels of ethylene oxide are to
be kept below the level of detection.
3228
METHYL GLUCETH20

dermal application.
3229
METHYL GLUCETH20 BENZOATE

fragrance.
3230
METHYL GLUCETH20 SESQUIHYDRATE

dermal application.
3231
METHYL GLUCOSE
DIOLEATE

dermal application.
3232
METHYL GLUCOSE
SESQUIOLEATE

dermal application.
3233
METHYL GLUCOSE
SESQUISTEARATE

dermal application.
77
Schedule 1
3234
METHYL
HEPTENONE

no more than 5%.
must be no more 1%.
3235
METHYL HEPTYL
KETONE

no more than 5%.
must be no more 1%.
3236
METHYL HEXYL
CARBINOL

flavour.
no more than 5%.
3237
METHYL HEXYL
KETONE

no more than 5%.
must be no more 1%.
3238
METHYL
HYDROGENATED

dermal application.
78
Schedule 1
ROSINATE
3239
METHYL
HYDROJASMONATE

dermal application.
3240
METHYL
HYDROXYBENZOAT
E
medicine label:
- (TOTBNZ) Contains
3241
METHYL IONONE

no more than 5%.
must be no more 1%.
3242
METHYL ISOBUTYL
KETONE

maximum daily dose.
3243
METHYL
ISOEUGENOL

no more than 5%.
79
Schedule 1
must be no more 1%.

3244
METHYL
ISOVALERATE

flavour.
no more than 5%.
3245
METHYL
JASMONATE

flavour.
no more than 5%.
3246
METHYL LAURATE

flavour.
no more than 5%.
3247
METHYL
LINOLEATE

fragrance.
3248
METHYL
LINOLENATE

fragrance.
3249
METHYL
MAGNESIUM
CHLORIDE

flavour.
80
Schedule 1

no more than 5%.
3250
METHYL
METHACRYLATE
3251
METHYL
METHACRYLATE
CROSSPOLYMER

in the eye.
3252
METHYL METHOXY
PYRAZINE

fragrance.
3253
METHYL
MYRISTATE

fragrance.
3254
METHYL NAPHTHYL
KETONE

fragrance.
3255
METHYL NONYL
KETONE

no more than 5%.
81
Schedule 1

must be no more 1%.
3256
METHYL
NONYLENATE

no more than 5%.
must be no more 1%.
3257
METHYL OCTIN
CARBONATE
3258
METHYL
PALMITATE

fragrance.
3259
METHYL PHENYL
CARBINOL

flavour.
no more than 5%.
3260
METHYL PHENYL
CARBINYL-ISOBUTYRATE

flavour.
no more than 5%.
3261
METHYL PHENYL
GLYCIDATE

fragrance.
82
Schedule 1

3262
METHYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
3263
METHYL
PHENYLCARBINYL
ACETATE

no more than 5%.
must be no more 1%.
3264
METHYL ROSINATE

fragrance.
3265
METHYL
SALICYLATE

dermal application.
For topical use, when the
concentration in a liquid preparation is
83
Schedule 1
For topical use, when the

concentration in a liquid preparation is
3266
METHYL STEARATE
3267
METHYL
THIOBUTYRATE

flavour.
no more than 5%.
3268
METHYL
TRIMETICONE

in the eye.
3269
METHYLATED
SPIRIT INDUSTRIAL
3270
METHYLBENZYL
ACETATE

fragrance.
3271
METHYLCELLULOS
A,E
84
Schedule 1
E
3272
METHYLCHLOROIS
OTHIAZOLINONE

dermal application.
3273
METHYLCYCLOHEX
ADIENE

fragrance.
3274
METHYLDIBROMO
GLUTARONITRILE

dermal application.
3275
METHYLENE BISBENZOTRIAZOLYL
TETRAMETHYLBUT
YLPHENOL

sunscreens.
in the eye.
3276
METHYLISOTHIAZO
LINONE

dermal application.
3277
METHYLMERCAPTA
N

flavour.
no more than 5%.
3278
METHYLPROPANEDI
OL

in the eye.
3279
METHYLSILANOL/SI
85
Schedule 1
LICATE
CROSSPOLYMER

3280
METHYLSTYRENE/V
INYLTOLUENE
COPOLYMER

dermal application.
3281
MICA

administration is oral, dental or
topical.
The concentration in oral medicines
The concentration in dental
toothpastes must be no more than
0.5%.
3282
MICROCALICIUM
ARENARIUM
A,H
3283
MICROCOCCUS
LUTEUS LYSATE

in the eye.
3284
MICROCOS
PANICULATA
A,H
3285
MICROSPORUM
GYPSEUM
A,H
3286
MILK - GOAT
3287
MILK - NONFAT DRY
E,H
If the product is for oral ingestion and

contains lactose, then the medicine
86
Schedule 1
to that effect).
3288
MILK - WHOLE DRY
If the product is for oral ingestion and

contains lactose, then the medicine
to that effect).
3289
MILK FAT

flavour.
no more than 5%.
3290
MILK THISTLE
FRUIT DRY
A,H
3291
MILK THISTLE
FRUIT POWDER
A,H
3292
MILLET
3293
MILLETTIA
DIELSIANA
A,H
3294
MIMOSA ABSOLUTE

flavour.
no more than 5%.
3295
MIMULUS
GUTTATUS
A,H
3296
MINT OIL
DEMENTHOLISED
A,E,H
3297
MINTLACTONE

flavour.
87
Schedule 1

no more than 5%.
3298
MITCHELLA REPENS
A,H
3299
MIXED TERPENES

fragrance.
3300
MOLASSES

flavour.
no more than 5%.
3301
MOLASSES BLACKSTRAP

Molasses - blackstrap.
label:
more sugars.
label:
88
Schedule 1

to that effect).
3302
MOLYBDENUM

When Molybdenum is sourced from
Molybdenum trioxide then the
maximum daily dose must be no more
than 125 micrograms.
When Molybdenum is sourced from
yeast - high molybdenum then the
must be no more than 62.5
micrograms.
3303
MOLYBDENUM
TRIOXIDE
Molybdenum is a mandatory
component of Molybdenum trioxide.
The maximum daily dose of
molybdenum from molybdenum
trioxide must be no more than 125
micrograms.
accepted percentage of Molybdenum
from Molybdenum trioxide is 66.65%.
The declared quantity of Molybdenum
from Molybdenum trioxide must be no
than 70% of the Molybdenum trioxide
3304
MOMORDICA
BALSAMINA
A,H
3305
MOMORDICA
CHARANTIA
A,H
3306
MOMORDICA
COCHINCHINENSIS
A,H
When Lycopene, Lutein or

Betocarotene are declared as
components, the plant part is restricted
to fruit flesh, fruit peel or seed aril.
89
Schedule 1
3307
MONARDA DIDYMA
A,H
3308
MONO- AND DIGLYCERIDES
3309
MONOBASIC
SODIUM
PHOSPHATE
A,E,H

supplementation, sodium is a
mandatory component of monobasic
sodium phosphate.
The percentage of sodium from
monobasic sodium phosphate should
weight of monobasic sodium
phosphate.
3310
MONOETHANOLAMI
NE

dermal application.
90
Schedule 1

3311
MONOPHOSPHOTHI
AMINE

medicine label:
balanced diet.
3312
MONOPHOSPHOTHI
AMINE DIHYDRATE

medicine label:
balanced diet.
3313
MONOPOTASSIUM
GLUTAMATE
A,E
3314
MONOSODIUM
DIHYDROGEN
CITRATE

3315
MONOSODIUM
GLUTAMATE
MONOHYDRATE
A,E
3316
MONSTERA
A,H
91
Schedule 1
DELICIOSA
3317
MONTAN WAX
3318
MORDANT RED 11

topical use.
3319
MORINDA
CITRIFOLIA
A,H
Only for use when the plant part is

fruit and the plant preparation is fruit
juice or fruit powder.
Fruit powder must be produced by
freeze drying the whole fruit
(excluding the seeds).
3320
MORINDA
OFFICINALIS
A,H
3321
MORINGA OLEIFERA A,H
3322
MORUS ALBA
A,H
3323
MORUS BOMBYCIS
A,H
3324
MORUS NIGRA
A,E,H
3325
MOSKENE

fragrance.
3326
MOTHERWORT
HERB DRY
A,H
3327
MOTHERWORT
HERB POWDER
A,H
3328
MUCUNA PRURIENS
A,H
Levodopa (of Mucuna pruriens) is a

mandatory component of Mucuna
pruriens.
92
Schedule 1
Mucuna pruriens) in the medicine

must be no more than 1mg/kg or
1mg/L or 0.1%.
3329
MULBERRY
3330
MUNG BEAN
3331
MURRAYA KOENIGII
A,H
3332
MURRAYA
PANICULATA
A,H
3333
MUSA X
PARADISIACA
A,H
3334
MUSK KETONE

dermal application.
3335
MUSK TIBETENE

fragrance.
3336
MUSK XYLOL

dermal application.
3337
MUSKS

3338
MUSTARD

component of Mustard.
provide more than 20 mg of allyl
isothiocyanate.
3339
MUSTARD OIL

component of Mustard oil.
isothiocyanate.
93
Schedule 1
3340
MUSTARD SEED OIL

component of Mustard seed oil.
isothiocyanate.
3341
MYOSOTIS
ARVENSIS
A,H
3342
MYRCENE

no more than 5%.
must be no more 1%.
3343
MYRCENYL
ACETATE

fragrance.
3344
MYRICA CERIFERA
A,E,H
3345
MYRISTIC ACID
3346
MYRISTIC
ALDEHYDE

no more than 5%.
must be no more 1%.
3347
MYRISTICA
A,E,H
94
Schedule 1
FRAGRANS
Myristica fragrans.
25 mL, the medicine must have a
label:
children' (or word to that effect).
3348
MYRISTYL
ALCOHOL

dermal application.
3349
MYRISTYL
LACTATE

dermal application.
3350
MYRISTYL
MYRISTATE

dermal application.
3351
MYROXYLON
BALSAMUM
A,E,H
3352
MYROXYLON
BALSAMUM VAR.
PEREIRAE
A,H
3353
MYRRH
A,H
3354
MYRRH OIL
A,E,H
3355
MYRRH RESIN

95
Schedule 1

no more than 5%.
must be no more 1%.
3356
MYRRHIS ODORATA
A,H
3357
MYRSINE AFRICANA
A,H
3358
MYRTENAL

flavour.
no more than 5%.
3359
MYRTENYL
ACETATE

flavour.
no more than 5%.
3360
MYRTLE ESSENCE
MAX

fragrance.
3361
MYRTLE OIL

fragrance.
3362
MYRTUS
COMMUNIS
A,E,H
96
Schedule 1
3363
N-BUTYL SULFIDE

no more than 5%.
must be no more 1%.
3364
N-HEXYL 2BUTENOATE

flavour.
no more than 5%.
3365
N-NONYL ALCOHOL

no more than 5%.
must be no more 1%.
3366
NAPHTHALENE
3367
NARDOSTACHYS
CHINENSIS
A,H
3368
NARINGIN


flavour.
no more than 5%.
97
Schedule 1
3369
NASTURTIUM
OFFICINALE
A,E,H
3370
NATURAL CHERRY
FLAVOUR

flavour.
no more than 5%.
3371
NAUCLEA
OFFICINALIS
A,H
3372
NELUMBO
NUCIFERA
A,H
3373
NELUMBO
NUCIFERA FLOWER
WAX

3374
NEOHESPERIDINDIHYDROCHALCON
E

3375
NEOMENTHOL

flavour.
no more than 5%.
3376
NEOPENTYL
GLYCOL
DIHEPTANOATE

in the eye.
98
Schedule 1

3377
NEOPENTYL
GLYCOL
DIISOSTEARATE

in the eye.
3378
NEOPENTYL
GLYCOL
DIOCTANOATE

in the eye.
3379
NEOPENTYL
GLYCOL
DIOCTANOATE/DIDE
CANOATE
3380
NEOPICRORHIZA
SCROPHULARIIFLOR
A
A,H
3381
NEPETA CATARIA
A,H

dermal application.

Nepeta cataria and must be declared in
the application.
3382
NERAL

flavour.
no more than 5%.
3383
NERIUM OLEANDER
A,H

Nerium oleander in the product must
be no more than 1mg/Kg or 1mg/L or
0.0001%.
99
Schedule 1
3384
NEROL

no more than 5%.
must be no more 1%.
3385
NEROLIDOL

no more than 5%.
must be no more 1%.
3386
NERYL-ISOBUTYRATE

flavour.
no more than 5%.
3387
NERYL ACETATE

no more than 5%.
must be no more 1%.
3388
NICKEL

100
Schedule 1
3389
NICOTIANA
TABACUM

3390
NICOTINAMIDE
A,E,H

medicine label:
balanced diet.
3391
NICOTINAMIDE
ASCORBATE
A,E

medicine label:
balanced diet.
3392
NICOTINIC ACID
A,E

than 100 mg of nicotinic acid per
dosage unit.
medicine label:
balanced diet.
3393
NIGELLA
DAMASCENA
A,H
101
Schedule 1
3394
NIGELLA SATIVA
A,E,H
3395
NIGRITELLA
ANGUSTIFOLIA
A,H
3396
NITRIC ACID
E,H

The concentration of nitric acid in the
3397
NONADIENOL

no more than 5%.
must be no more 1%.
3398
NONANAL

no more than 5%.
must be no more 1%.
3399
NONANOIC ACID

no more than 5%.
must be no more 1%.
102
Schedule 1
3400
NONIVAMIDE

flavour.
no more than 5%.
3401
NONOXINOL 10

dermal application.
3402
NONOXINOL 12
For use in hand scrub formulations for

healthcare professionals only.
in the eye.
3403
NONOXINOL 5

fragrance.
3404
NONOXINOL 9

dermal application.
3405
NONYL ACETATE

fragrance.
3406
NOOTKATONE

103
Schedule 1
flavour.
no more than 5%.
3407
NOPYL ACETATE

fragrance.
3408
NORDIHYDROGUAI
ARETIC ACID

in the eye.
3409
NOTOPTERYGIUM
FORBESII
A,H
3410
NOTOPTERYGIUM
INCISIUM
A,H
3411
NUPHAR JAPONICA
A,H
3412
NUPHAR LUTEA
A,H
3413
NUTMEG DRY
A,E,H

Nutmeg Dry.
concentration of safrole from all
ingredients in the medicine must be no
more than 0.1%.
concentration of safrole from all
ingredients in the medicine must be no
more than 1%.
3414
NUTMEG OIL
A,E,H

Nutmeg oil.
104
Schedule 1

When the concentration of Nutmeg oil
in the medicine is more than 50%, the
on the container and requires the
medicine label:
3415
NUTMEG POWDER
A,E,H

Nutmeg powder.
3416
NUX VOMICA DRY
A,H
Strychnine (of Strychnos spp.) is a

mandatory component of Nux Vomica
Dry.
The concentration of in the medicine
1mg/L or 0.0001%.
3417
NUX VOMICA
POWDER

mandatory component of Nux Vomica
Powder.
105
Schedule 1

1mg/L or 0.0001%.
3418
NYCTANTHES
ARBOR-TRISTIS
A,H
3419
NYLON

dermal application.
3420
NYLON-12

dermal application.
3421
NYLON 6/12

dermal application.
3422
NYMPHAEA ALBA
A,E,H
3423
NYMPHAEA
CAERULEA

in the eye.
The concentration in the medicine to
be no more than 0.3%.
Only for use in liquid extracts where
the plant part is the flower and the
solvent in 100% water.
3424
NYMPHAEA
ODORATA
A,H
3425
OAK CHIPS
EXTRACT

flavour.
no more than 5%.
3426
OAKMOSS

fragrance.
106
Schedule 1
3427
OAKMOSS
ABSOLUTE

no more than 5%.
must be no more 1%.
3428
OAT
E,H

ingredient.
Oat when the route of administration is
other than topical or muscosal, the
statement:
3429
OAT BRAN

Oat bran when the route of
mucosal.
label:
3430
OATMEAL
COLLOIDAL
A,E

Oatmeal colloidal when the route of
mucosal.
107
Schedule 1

label:
3431
OCIMENE

no more than 5%.
must be no more 1%.
3432
OCIMENYL
ACETATE

no more than 5%.
must be no more 1%.
3433
OCIMUM
BASILICUM
A,E,H
When the plant part is oil, Methyl

chavicol is a mandatory component of
Ocimum basilicum.
container, and requires the following
108
Schedule 1

label:
3434
OCIMUM
KILIMANDSCHARIC
UM
A,H

Ocimum kilimandscharicum.
When the plant preparation is oil,
component of Ocimum
kilimandscharicum.
the medicine label:
no more than 12.5%.
109
Schedule 1

label:
3435
OCIMUM MINIMUM
A,H

Ocimum minimum.
110
Schedule 1

the medicine label:
children (or words to that effect).
3436
OCIMUM
TENUIFLORUM
A,H

Ocimum tenuiflorum.
the medicine label:
3437
OCOTEA
ODORIFERA
A,H

Ocotea odorifera.
3438
OCTACOSANOL
111
Schedule 1
3439
OCTADECANAL

no more than 5%.
must be no more 1%.
3440
OCTADECENE/MA
COPOLYMER

dermal application.
3441
OCTAHYDRO-4,7METHANO-3AHINDENE-3ACARBOXYLIC ACID,
ETHYL ESTER

fragrance.
OCTAHYDROCOUM
ARIN
3442

fragrance.
3443
OCTAN-1-OL

no more than 5%.
must be no more 1%.
3444
OCTANAL
DIMETHYL ACETAL

112
Schedule 1

no more than 5%.
must be no more 1%.
3445
OCTANOHYDROXA
MIC ACID

in the eye.
3446
OCTANOIC ACID
Only for use in oral and topical

medicines.
When for topical use, the
no more than 2% (w/w).
3447
OCTHILINONE

dermal application.
3448
OCTOCRYLENE

sunscreens.
in the eye.
3449
OCTOXINOL 10

dermal application.
3450
OCTYL ACETATE

113
Schedule 1
no more than 5%.

must be no more 1%.
3451
OCTYL
HYDROXYSTEARAT
E

dermal application.
3452
OCTYL
ISOBUTYRATE

flavour.
no more than 5%.
3453
OCTYL
ISONONANOATE

dermal application.
3454
OCTYL
METHOXYCINNAMA
TE

sunscreens.
in the eye.
3455
OCTYL PALMITATE

dermal application.
3456
OCTYL SALICYLATE

sunscreens.
in the eye.
3457
OCTYL STEARATE
114
Schedule 1
dermal application.
3458
OCTYLBICYCLOHEP
TENEDICARBOXIMI
DE

dermal application.
label:
- (OBCARB) 'Contains
octylbicycloheptenedicarboximide' (or
3459
OCTYLDODECANOL

dermal application.
3460
OCTYLDODECETH25

in the eye.
Residual levels of 1,4-dioxane and
ethylene oxide (and related
substances) are to be kept below the
level of detection.
3461
OCTYLDODECYL
CITRATE
CROSSPOLYMER

3462
OCTYLDODECYL
NEOPENTANOATE

dermal application.
3463
OCTYLDODECYL
STEARATE

in the eye.
115
Schedule 1

3464
OENANTHATE

fragrance.
3465
OENANTHE
AQUATICA

3466
OENANTHE
CROCATA
A,H

3467
OENOTHERA
BIENNIS
A,E,H
3468
OENOTHERA
STRICTA
A,H
3469
OKOUBAKA
AUBREVILLEI
A,H
3470
OLDENLANDIA
DIFFUSA
A,E,H
3471
OLEA EUROPAEA
A,E,H
3472
OLEIC ACID
3473
OLETH-10

dermal application.
3474
OLETH-2

dermal application.
Dioxane and Ethylene oxide are
mandatory components of Oleth-2.
The concentration of Dioxane in the
116
Schedule 1

The concentration of Ethylene oxide in
3475
OLETH-20

dermal application.
3476
OLETH-3

dermal application.
3477
OLETH-3
PHOSPHATE

in the eye.
3478
OLETH-5

dermal application.
3479
OLEYL ALCOHOL

dermal application.
3480
OLIBANUM OIL
A,E,H
3481
OLIGOFRUCTOSE
A,E
3482
OLIVE
3483
OLIVE OIL
A,E,H
3484
OMEGA-3-ACID
ETHYL ESTERS 90

mg EPA, DHA and DPA combined,
when used alone or in combination
with other sources of omega-3 fatty
acids.
label:
-Individuals taking anticoagulants
117
Schedule 1
should seek medical advice before

taking this product (or words to that
effect).
-To be taken with food (or words to
that effect).
3485
OMEGA-3 FISH OIL

PHYTOSTEROL
ESTERS

label:
- (VOPE) 'There is no benefit from
taking more than 3g/day of
phytosterols from all sources'
3486
ONION
3487
ONION OIL
A,H
3488
ONONIS SPINOSA
A,E,H
3489
ONOPORDON
ACANTHIUM
A,H
3490
ONOSMODIUM
VIRGINIANUM
A,H
3491
OPHIOPOGON
JAPONICUS
A,H
3492
OPOPANAX
CHIRONIUM
A,H
3493
OPOPANAX OIL

no more than 5%.
118
Schedule 1
must be no more 1%.

3494
OPUNTIA FICUSINDICA
A,H
3495
ORANGE
3496
ORANGE FLOWER
ABSOLUTE

no more than 5%.
must be no more 1%.
3497
ORANGE FLOWER
OIL
A,E,H

Orange Flower Oil, the maximum
3498
ORANGE JUICE

flavour.
no more than 5%.
3499
ORANGE JUICE OIL

no more than 5%.
must be no more 1%.
3500
ORANGE OIL
A,E,H

Orange Oil, the maximum
119
Schedule 1

3501
ORANGE OIL BITTER

no more than 5%.
must be no more 1%.
3502
ORANGE OIL BITTER

COLDPRESSED
A,E,H
For use in oral medicines or in soaps

or bath and shower gels that are
washed off the skin.
When for topical use, the medicine
Orange Oil Bitter Coldpressed, the
Oxedrine.
3503
ORANGE OIL COLD

PRESSED

no more than 5%.
must be no more 1%.
3504
ORANGE OIL
A,E,H
120
Schedule 1
DISTILLED
3505
ORANGE OIL SWEET
Orange Oil Distilled, the maximum

E

no more than 5%.
must be no more 1%.
3506
ORANGE OIL
TERPENELESS
A,E,H

Orange Oil Terpeneless, the maximum
3507
ORANGE PEEL

flavour.
no more than 5%.
3508
ORANGE PEEL
DRIED BITTER
A,E,H

Orange Peel Dried Bitter, the
Oxedrine.
3509
ORANGE PEEL OIL

SWEET
TERPENELESS

no more than 5%.
must be no more 1%.
121
Schedule 1
3510
ORANGE ROUGHY
OIL
3511
OREODAPHNE
CALIFORNICA
A,H
3512
ORIGANUM
MAJORANA
A,H
3513
ORIGANUM OIL

dermal application.

with other ingredients as a fragrance.
no more than 1%.
3514
ORIGANUM OIL
SPANISH
A,E,H
3515
ORIGANUM
VULGARE
A,E,H
3516
ORNITHINE
A,E
3517
ORNITHINE
ASPARTATE
A,E
3518
ORNITHINE
MONOHYDROCHLO
RIDE
A,E
3519
ORNITHOGALUM
UMBELLATUM
A,H
3520
OROSTACHYS
FIMBRIATA
A,H
3521
OROXYLUM
INDICUM
A,H
3522
ORRIS

flavour.
no more than 5%.
122
Schedule 1
3523
ORRIS CONCRETE

flavour.
no more than 5%.
3524
ORRIS ROOT
EXTRACT

flavour.
no more than 5%.
3525
ORRIS ROOT OIL
A,E,H
3526
ORRIS ROOT RESIN

flavour.
no more than 5%.
3527
ORTHO-CYMEN-5OL

in the eye.
3528
ORTHO-TERTBUTYLCYCLOHEXY
L ACETATE

no more than 5%.
must be no more 1%.
123
Schedule 1
3529
ORTHOSIPHON
ARISTATUS
A,H
3530
ORYZA SATIVA
A,E,H
3531
ORYZANOL
3532
OSBECKIA
CHINENSIS
A,H
3533
OSMANTHUS
ABSOLUTE

no more than 5%.
3534
OSMANTHUS
FRAGRANS

flavour.
no more than 5%.
3535
OTTELIA
ALISMOIDES
A,H
3536
OXACYCLOHEPTAD
EC-11-EN-2-ONE

fragrance.
3537
OXACYCLOHEXADE
CAN-2-ONE

dermal application.
3538
OXACYCLOHEXADE
CEN-2-ONE

fragrance.
124
Schedule 1
3539
OXALIC ACID
3540
OXALIS
ACETOSELLA
A,H
3541
OXYBENZONE


sunscreens.
in the eye.
3542
OYSTER
3543
OYSTER SHELL
A,E,H
125
Schedule 1
Column 1
3544
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine

P-ALPHA-DIMETHYL
STYRENE

no more than 5%.
must be no more 1%.
3545
P-ANISIC ACID

3546
PADIMATE O

sunscreens.
in the eye.
3547
PADINA PAVONICA
THALLUS
PHYTOSTEROLS

in the eye.
Schedule 1
3548
PAEONIA
LACTIFLORA
A,E,H
3549
PAEONIA OBOVATA
A,H
3550
PAEONIA
SUFFRUTICOSA
A,E,H
3551
PAEONIA VEITCHII
A,H
3552
PALIURUS SPINACHRISTI
A,H
3553
PALLADIUM
3554
PALM FRUIT OIL
A,E,H
3555
PALM GLYCERIDES
3556
PALM GLYCERIDES HYDROGENATED


in the eye.
3557
PALM KERNEL OIL
A,E,H
3558
PALM KERNEL OIL FRACTIONATED
A,E
3559
PALM
TOCOTRIENOLS
COMPLEX
A,H
3560
PALMAROSA OIL
A,E,H
3561
PALMITIC ACID
3562
PALMITOYL
DIPEPTIDE-7


Schedule 1
in the eye.
3563
3564
PALMITOYL
HYDROXYPROPYLT
RIMONIUM
AMYLOPECTIN/GLY
CERIN
CROSSPOLYMER
PALMITOYL
OLIGOPEPTIDE

in the eye.
in the eye.
3565
PALMITOYL
PENTAPEPTIDE-3

in the eye.
3566
PALMITOYL
TETRAPEPTIDE-3

in the eye.
3567
PANAX GINSENG
A,E,H
3568
PANAX JAPONICUS
A,H
3569
PANAX
NOTOGINSENG
A,H
3570
PANAX
PSEUDOGINSENG
A,H
Schedule 1
3571
PANAX
QUINQUEFOLIUS
A,H
3572
PANICUM
MILIACEUM
A,H
3573
PANTETHINE

dermal application.
3574
PANTHENOL
A,E

medicine label:
balanced diet.
3575
PANTHENYL ETHYL
ETHER

dermal application.
3576
PANTOLACTONE
3577
PANTOTHENIC ACID
A,E

0.1%.
3578
PANTOTHENIC ACID
POLYPEPTIDE

in the eye.
3579
PAPAIN
A,E
3580
PAPER

dermal application.
3581
PAPRIKA
OLEORESIN

Schedule 1

no more than 5%.
3582
PARA-CRESOL

no more than 5%.
must be no more 1%.
3583
PARA-CRESYL
ACETATE

no more than 5%.
must be no more 1%.
3584
PARA-CRESYL
ISOBUTYRATE

fragrance.
3585
PARA-CRESYL
PHENYLACETATE

fragrance.
3586
PARA-CYMENE

Schedule 1
no more than 5%.
must be no more 1%.
3587
PARAETHOXYBENZALDE
HYDE

flavour.
no more than 5%.
3588
PARA-HYDROXY
BENZALACETONE

fragrance.
3589
PARAHYDROXYBENZOIC
ACID
3590
PARA-MENTHA-8THIOL-3-ONE

no more than 5%.
must be no more 1%.
3591
PARA-METHYL
ACETOPHENONE

Schedule 1

no more than 5%.
must be no more 1%.
3592
PARA-METHYL
ANISOLE

fragrance.
3593
PARA-METHYL
DIMETHYLBENZYL
CARBINOL

no more than 5%.
must be no more 1%.
3594
PARA-PROPYL
ANISOLE

fragrance.
3595
PARA-TERTBUTYLCYCLOHEXY
L ACETATE

fragrance.
3596
PARA-TERTBUTYLPHENYLALPHAMETHYLHYDROCIN

fragrance.
Schedule 1
NAMIC ALDEHYDE
3597
PARATOLUALDEHYDE

E

no more than 5%.
must be no more 1%.
3598
PARA-TOLYL
ACETALDEHYDE

no more than 5%.
must be no more 1%.
3599
PARAFFIN - HARD
3600
PARAFFIN - LIGHT
LIQUID
A,E

3601
PARAFFIN - LIQUID
A,E

3602
PARAMERIA
LAEVIGATA
A,H
Schedule 1
3603
PARIETARIA
JUDAICA
A,H
3604
PARIS POLYPHYLLA
A,H
3605
PARIS
QUADRIFOLIA
A,H
3606
PARSLEY
E,H
3607
PARSLEY HERB DRY
A,E,H
3608
PARSLEY HERB OIL
A,E,H
3609
PARSLEY HERB
POWDER
A,E,H
3610
PARSLEY SEED OIL
A,E,H
3611
PARTHENOCISSUS
TRICUSPIDATA
A,H
3612
PARTIALLY
REFINED PORPHYRA
YEZOENSIS
CYTOPLASM
EXTRACT
3613
PASPALUM
NOTATUM
A,H
3614
PASSIFLORA
CAERULEA
A,H
3615
PASSIFLORA EDULIS
3616
PASSIFLORA HERB
DRY
A,H
3617
PASSIFLORA
INCARNATA
A,E,H
3618
PATCHOULI OIL

in the eye.

Schedule 1

no more than 5%.
must be no more 1%.
3619
PATENT BLUE V

and topical use.
3620
PATENT BLUE V
ALUMINIUM LAKE

and topical use.
3621
PATRINIA
SCABIOSIFOLIA
A,H
3622
PATRINIA VILLOSA
A,H
3623
PAULLINIA CUPANA
A,E,H

Paullinia cupana when used for oral
ingestion.
label:
of caffeine.
medicine label:
10
Schedule 1

3624
PAULLINIA
PINNATA
A,H
3625
PAWPAW
3626
PEA
3627
PEA STARCH
3628
PEACH
3629
PEANUT

label:
- (PEANUT) 'Contains [insert
ingredient name]'.
3630
PEAR
3631
PECAN
3632
PECTIN
A,E
3633
PEG-10 SOYA
STEROL

dermal application.
3634
PEG-100 STEARATE

dermal application.
3635
PEG-12 DILAURATE
3636
PEG-12
DIMETICONE/PPG-20
CROSSPOLYMER

3637
PEG-120 METHYL
GLUCOSE DIOLEATE

dermal application.
3638
PEG-120 STEARATE

dermal application.
11
Schedule 1
3639
PEG-15 COCAMINE

dermal application.
3640
PEG-150
DISTEARATE

dermal application.
3641
PEG-20 ALMOND
GLYCERIDES

in the eye.
3642
PEG-20 METHYL
GLUCOSE
DISTEARATE

dermal application.
3643
PEG-20 METHYL
GLUCOSE
SESQUISTEARATE

dermal application.
3644
PEG-20 SORBITAN
ISOSTEARATE

dermal application.
3645
PEG-20 STEARATE

dermal application.
3646
PEG-25 PABA

topical sunscreens for dermal
application. The concentration in the
3647
PEG-30
DIPOLYHYDROXYST
EARATE

dermal application.
3648
PEG-30 STEARATE

dermal application.
3649
PEG-35 CASTOR OIL
3650
PEG-4 DILAURATE

dermal application.
3651
PEG-4 LAURATE

dermal application.
12
Schedule 1

mandatory components of PEG-4
laurate.
3652
PEG-4 STEARATE
3653
PEG-40 CASTOR OIL
3654
PEG-40
HYDROGENATED
CASTOR OIL
3655
PEG-40 SORBITAN
DIISOSTEARATE

dermal application.

dermal application.
mandatory components of PEG-40
sorbitan diisostearate.
3656
PEG-40 STEARATE

dermal application.
3657
PEG-45/DODECYL
GLYCOL
COPOLYMER

dermal application.
3658
PEG-5 GLYCERYL
STEARATE

dermal application.
3659
PEG-50 STEARATE
13
Schedule 1
dermal application.
3660
PEG-55 PROPYLENE
GLYCOL OLEATE

in the eye.
3661
PEG-6 LAURAMIDE

dermal application.
3662
PEG-60 ALMOND
GLYCERIDES

in the eye.
The concentration when used in
medicines applied directly to the skin
The concentration when used in bath
oil medicines must be no more than
30%.
3663
PEG-60 GLYCERYL
ISOSTEARATE

in the eye.
3664
PEG-60
HYDROGENATED
CASTOR OIL

dermal application.
3665
PEG-7 COCAMIDE

dermal application.
3666
PEG-7 GLYCERYL
COCOATE

dermal application.
3667
PEG-7
HYDROGENATED

dermal application.
14
Schedule 1
CASTOR OIL
3668
PEG-75 LANOLIN

dermal application.
3669
PEG-75 STEARATE

in the eye.
3670
PEG-8 CETYL
DIMETHICONE

in the eye.
3671
PEG-8 DILAURATE

in the eye.
3672
PEG-8 DISTEARATE

dermal application.
3673
PEG-8 LAURATE

in the eye.
The levels of possible impurities such
as ethylene oxide (and related
material) must be kept below the level
of detection.
3674
PEG-8 PROPYLENE
15
Schedule 1
GLYCOL COCOATE
3675
PEG-8 STEARATE

dermal application.
3676
PEG/PPG-18/18
DIMETHICONE

in the eye.
3677
PELARGONIUM
GRAVEOLENS
A,E,H
3678
PELLITORINE

flavour.
no more than 5%.
3679
PELTIGERA CANINA
A,H
3680
PENICILLIUM
EXPANSUM
A,H
3681
PENNYROYAL OIL
A,E,H
D-Pulegone is a mandatory component

of Pennyroyal Oil.
container is more than 15 mL, the
concentration of D-Pulegone in the
When the concentration of D-Pulegone
in the preparation is more than 4% and
is 15 mL or less, the medicine must
medicine label:
16
Schedule 1

When the medicine is for topical use,
Pennyroyal Oil.
When the medicine is for a use other
than topical, the maximum
more than 50 mg of Pennyroyal Oil.
3682
PENTAERYTHRITYL
TETRA-DI-T-BUTYL
HYDROXYHYDROCI
NNAMATE

in the eye.
3683
PENTAERYTHRITYL
TETRAISOSTEARAT
E

in the eye.
3684
PENTAERYTHRITYL
TETRALAURATE

dermal application.
3685
PENTAMETHYLHEP
TENONE

fragrance.
3686
PENTANE

17
Schedule 1
no more than 5%.
must be no more 1%.
3687
PENTASODIUM
ETHYLENEDIAMINE
TETRAMETHYLENE
PHOSPHONATE

in the eye.
3688
PENTYLENE
GLYCOL

in the eye.
3689
PEPPER BLACK
E,H
3690
PEPPER OIL
TERPENELESS

fragrance.
3691
PEPPER WHITE
E,H
3692
PEPPERMINT
AMERICAN EXT.

flavour.
no more than 5%.
3693
PEPPERMINT LEAF
A,E,H
18
Schedule 1
DRY
3694
PEPPERMINT LEAF
POWDER
A,E,H
3695
PEPPERMINT OIL
A,E,H
3696
PEPPERMINT OIL
TERPENELESS

no more than 5%.
must be no more 1%.
3697
PEPPERMINT
TERPENES

flavour.
no more than 5%.
3698
PERFLUOROPOLYM
ETHYLISOPROPYL
ETHER

dermal application.
3699
PERHYDRO-3,6DIMETHYL-BENZO
[B] FURAN-2-ONE

no more than 5%.
must be no more 1%.
3700
PERILLA
FRUTESCENS
A,E,H
Rosmarinic acid and vicenin-2 are

only permitted for use if the plant part
of Perilla frutescens is leaf.
19
Schedule 1
3701
PERILLALDEHYDE

no more than 5%.
must be no more 1%.
3702
PERLITE

in the eye.
3703
PERMETHRIN
3704
PERSEA
AMERICANA
A,E,H
3705
PERSIC OIL
A,E,H
The concentration of in the medicine

Amygdalin and Hydrocyanic acid are

mandatory components of Persic oil.
The concentration of amygdalin in the
The concentration of Hydrocyanic acid
0.0000001%.
3706
PERSICARIA
CHINENSIS
A,H
3707
PERSICARIA
TINCTORIA
A,H
3708
PERSIMMON
3709
PERU BALSAM
A,E,H
20
Schedule 1
3710
PERU BALSAM OIL
A,E,H
3711
PETITGRAIN
MANDARIN OIL

flavour
The final concentration of the oil in
the flavour does not exceed 30%
no more than 5%
3712
PETITGRAIN OIL

no more than 5%.
must be no more 1%.
3713
PETITGRAIN OIL
PARAGUAY
A,E,H

Petitgrain Oil Paraguay, the maximum
3714
PETITGRAIN OIL
TERPENELESS

no more than 5%.
must be no more 1%.
3715
PETROSELINUM
CRISPUM
A,E,H
3716
PEUCEDANUM
A,E,H
21
Schedule 1
PRAERUPTORUM
3717
PEUMUS BOLDUS
A,H
Volatile oil components (of Peumus

boldus) is a mandatory component.
volatile oil components (of Peumus
boldus).
3718
PHALARIS
ARUNDINACEA
A,H
3719
PHALARIS
CANARIENSIS
A,H
3720
PHASEOLUS
COCCINEUS
A,H
3721
PHASEOLUS
VULGARIS
A,H
3722
PHELLINUS
ROBINIAE
A,E,H
3723
PHELLODENDRON
AMURENSE
A,E,H
3724
PHELLODENDRON
CHINENSE
A,H
3725
PHENACETIN

dermal application.
3726
PHENETHYL 2METHYLBUTYRATE

no more than 5%.
22
Schedule 1
must be no more 1%.

3727
PHENETHYL
ACETATE

no more than 5%.
must be no more 1%.
3728
PHENETHYL
ALCOHOL

dermal application.
label:
- (PHEALC) 'Contains phenethyl
alcohol' (or words to that effect).
3729
PHENETHYL
BENZOATE

in the eye.
3730
PHENETHYL
DIMETHICONE

in the eye.
3731
PHENETHYL
ISOAMYL ETHER

fragrance.
23
Schedule 1
3732
PHENETHYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
3733
PHENETHYL
ISOVALERATE

no more than 5%.
must be no more 1%.
3734
PHENETHYL
PHENYLACETATE

no more than 5%.
must be no more 1%.
3735
PHENETHYL
SALICYLATE

no more than 5%.
24
Schedule 1
must be no more 1%.

3736
PHENOL

dermal application.
label:
- (PHENOL) 'Contains phenol' (or
The concentration of phenols in the
medicine including cresols and
xylenols and any other homologue of
phenol boiling below 220 degrees
centigrade must be no more than 3%.
3737
PHENOXYETHANOL

dermal application.
label:
- (PHOETH) 'Contains
phenoxyethanol' (or words to that
effect).
3738
PHENOXYETHYL
ISOBUTYRATE

no more than 5%.
must be no more 1%.
3739
PHENOXYETHYLPA
RABEN

dermal application.
3740
PHENYL
DIMETHICONE

dermal application.
25
Schedule 1
3741
PHENYL
TRIMETHICONE

dermal application.
3742
PHENYLACETALDE
HYDE

no more than 5%.
must be no more 1%.
3743
PHENYLACETALDE
HYDE DIMETHYL
ACETAL

no more than 5%.
must be no more 1%.
3744
PHENYLACETALDE
HYDE
GLYCERYLACETAL

fragrance.
3745
PHENYLACETIC
ACID

no more than 5%.
must be no more 1%.
26
Schedule 1
3746
PHENYLALANINE
A,E
When for oral ingestion the medicine

- (PKU) 'Phenylketonurics are warned
that this medicine contains
phenylalanine' (or words to that
effect).
When the medicine contains more than
500mg in the maximum recommended
daily dose it requires the following
label:
or likely to become pregnant'.
3747
PHENYLBENZIMIDA
ZOLE SULFONIC
ACID

sunscreens.
in the eye.
3748
PHENYLETHYL
BUTYRATE

no more than 5%.
3749
PHENYLETHYL
CAPROATE

fragrance.
3750
PHENYLETHYL

27
Schedule 1
CAPRYLATE
no more than 5%.
must be no more 1%.
3751
PHENYLETHYL
CINNAMATE

fragrance.
3752
PHENYLETHYL
FORMATE

no more than 5%.
must be no more 1%.
3753
PHENYLETHYL
METHYLETHYL
CARBINOL

no more than 5%.
3754
PHENYLETHYL
PROPIONATE

no more than 5%.
28
Schedule 1

3755
PHENYLETHYL
TIGLATE

fragrance.
3756
PHENYLISOPROPYL
DIMETICONE

in the eye.
3757
PHENYLPROPANOL

in the eye.
3758
PHLEUM PRATENSE
A,H
3759
PHLOXINE B

and topical use.
3760
PHLOXINE B
ALUMINIUM LAKE

and topical use.
3761
PHOENIX
DACTYLIFERA
A,E,H
3762
PHOSPHATIDYL
CHOLINE
3763
PHOSPHOLIPIDS

dermal application and not intended
for use in the eye.
29
Schedule 1
3764
PHOSPHORIC ACID
E,H

The concentration in liquid medicines
3765
PHOSPHORUS
3766
PHOTINIA
SERRULATA
A,H
3767
PHRAGMITES
AUSTRALIS
A,H
3768
PHYLA DULCIS
A,H
3769
PHYLLANTHUS
AMARUS
A,H
3770
PHYLLANTHUS
EMBLICA
A,E,H


dermal application.
When ascorbic acid is claimed as a
component the plant part is restricted
to fruit.
3771
PHYLLOSTACHYS
NIGRA
A,E,H
3772
PHYSALIS
ALKEKENGI
A,H
3773
PHYSALIS
PUBESCENS
A,H
3774
PHYTANTRIOL

dermal application.
3775
PHYTOL

fragrance.
30
Schedule 1

3776
PHYTOLACCA
AMERICANA
A,H

dose of the medicine must contain no
herb.
3777
PHYTOMENADIONE
A,E

medicine label:
balanced diet.
3778
PHYTOSPHINGOSIN
E

in the eye.
3779
PHYTOSTEROL
COMPLEX CONIFER
3780
PHYTOSTERYL/OCT
YLDODECYL
LAUROYL
GLUTAMATE

in the eye.
3781
PICEA ABIES
A,H
3782
PICEA MARIANA
A,H
3783
PICRASMA EXCELSA A,E,H
3784
PICRORRHIZA
A,E,H
31
Schedule 1
KURROA
3785
PIGMENT BLUE 15

topical and dental use.
The concentration in medicine must be
no more than 0.003%.
3786
PIGMENT BLUE 15:1

topical use.
in the eye.
3787
PIGMENT GREEN 7
When for dental use, the concentration

0.003%.
no more than 0.17%.
topical and dental use.
3788
PIGMENT RED 4

topical use.
3789
PIGMENT RED 53

topical use.
3790
PIGMENT RED 57

topical use.
3791
PIGMENT RED 57
ALUMINIUM LAKE

topical use.
3792
PIGMENT RED 63

topical use.
3793
PIGMENT WHITE 26

topical use.
32
Schedule 1
3794
PIGMENT YELLOW
12

topical use.
3795
PILOCARPUS
JABORANDI
A,H
Pilocarpine is a mandatory component

of Pilocarpus jaborandi.
The concentration of pilocarpine in the
0.025%.
3796
PILOCARPUS
MICROPHYLLUS
A,H

of Pilocarpus microphyllus.
0.025%.
3797
PILOCARPUS
PINNATIFOLIUS
A,H

of Pilocarpus pinnatifolius.
0.025%.
3798
PIMENTA FRUIT OIL
A,E,H
3799
PIMENTA LEAF OIL
A,E,H
3800
PIMENTA
OFFICINALIS
A,E,H
3801
PIMENTA
RACEMOSA
A,E,H
When the plant preparation for

Pimenta racemosa is an oil and the
concentration of this oil in the
Pimenta racemosa is an oil, the
medicine is more than 25%, and the
more than 15 mL, a restricted flow
33
Schedule 1
Pimenta racemosa is an oil, the

medicine is more than 25%, and the
more than 15 mL but no more than 25
mL, a child resistant closure and
the container.
label:
3802
PIMPINELLA
ANISUM
A,E,H

Pimpinella anisum is an oil and the
A restricted flow insert is must be
fitted on the container.
label:
3803
PIMPINELLA
SAXIFRAGA
A,E,H
3804
PINE NEEDLE OIL

SCOTCH
A,E,H
3805
PINE NEEDLE OIL

TERPENELESS

34
Schedule 1
no more than 5%.

3806
PINE OIL AROMATIC
A,E,H
3807
PINE OIL PUMILIO
A,E,H
3808
PINEAPPLE
3809
PINEAPPLE OILS

fragrance.
3810
PINELLIA TERNATA
A,H
3811
PINUS CONTORTA
A,E,H
3812
PINUS ELLIOTTII

no more than 5%
3813
PINUS MASSONIANA
A,E,H
3814
PINUS MONTICOLA
A,E,H
3815
PINUS MUGO
A,E,H
3816
PINUS PALUSTRIS

fragrance.
35
Schedule 1

3817
PINUS PINASTER
A,E,H
3818
PINUS PONDEROSA
A,E,H
3819
PINUS RADIATA
A,E,H
3820
PINUS STROBUS
A,E,H
3821
PINUS SYLVESTRIS
A,E,H
3822
PINUS
TABULIFORMIS
A,E,H
3823
PINUS
YUNNANENSIS

fragrance.
3824
PIPENZOLATE
BROMIDE

flavour.
no more than 5%.
3825
PIPER CHABA
A,E,H
3826
PIPER CUBEBA
A,E,H
3827
PIPER EXCELSUM
VAR. MAJOR
A,H
3828
PIPER KADSURA
A,E,H
3829
PIPER LONGUM
A,E,H
3830
PIPER
METHYSTICUM
A,H
Kavalactones (of Piper methysticum)

is a mandatory component of Piper
methysticum.
When used in oral medicines, the
maximum daily dose of kavalactones
36
Schedule 1
(of Piper methysticum) must be no

more than 250 mg.
If the dosage form is tablet or capsule
then the quantity of kavalactones (of
Piper methysticum) must be no more
than 125 mg per tablet or capsule.
Oral medicines containing more than
25 mg of kavalactones (of Piper
methysticum) per dose require the
medicine label:
- (PIPER) 'Not for prolonged use. If
symptoms persist - seek advice from a
healthcare practitioner. Not
recommended for pregnant or lactating
women (or words to that effect). May
harm the liver.'
The plant part must be root or
rhizome.
When for oral use, the plant
preparation must be an aqueous
dispersion or aqueous extract of dried
whole or peeled root or rhizome.
When for topical use on the rectum,
vagina or throat, the medicine may
only contain dried whole or peeled
root or rhizome or aqueous dispersions
or aqueous extracts of whole or peeled
root or rhizome.
When the container type is tea bag the
maximum quantity per tea bag must be
no more than 3 grams of dried whole
or peeled root or rhizomes.
3831
PIPER NIGRUM
A,E,H
3832
PIPER
SARMENTOSUM
A,E,H
37
Schedule 1
3833
PIPERIDINE

flavour.
no more than 5%.
3834
PIPERITONE

no more than 5%.
3835
PIPERONAL

no more than 5%.
must be no more 1%.
3836
PIPERONYL
ACETONE

no more than 5%.
3837
PIPERONYL
BUTOXIDE

dermal application.
label:
38
Schedule 1
- (PIPBUT) 'Contains piperonyl

butoxide' (or words to that effect).
3838
PIROCTONE
OLAMINE

in the eye.
must be no more than 1% in washon/wash-off medicines and 0.5% in
leave-on medicines.
3839
PISCIDIA PISCIPULA
A,E,H
3840
PISTACIA
LENTISCUS
A,E,H
3841
PISUM SATIVUM
A,E,H
3842
PLACENTA
Only for use as an active homeopathic

ingredient.
3843
PLANTAGO AFRA
A,E,H

label:
3844
PLANTAGO
ARENARIA
A,H

label:
3845
PLANTAGO
ASIATICA
A,H

label:
39
Schedule 1
3846
PLANTAGO
LANCEOLATA
A,E,H

label:
3847
PLANTAGO MAJOR
A,E,H

label:
3848
PLANTAGO OVATA
A,H

label:
3849
PLANTAGO SEED
DRY
A,H

label:
3850
PLATANUS
OCCIDENTALIS
A,E,H
3851
PLATANUS
RACEMOSA
A,H
3852
PLATANUS X
ACERIFOLIA
A,H
3853
PLATYCODON
GRANDIFLORUS
A,E,H
3854
PLICATONE

40
Schedule 1
fragrance.
3855
PLUM
3856
PLUMBAGO
EUROPAEA
A,H
3857
PLUMERIA ALBA
A,E,H
3858
PLUMERIA RUBRA
A,E,H
3859
POA NEMORALIS
A,H
3860
POA PRATENSIS
A,H
3861
PODOPHYLLUM
PELTATUM
A,H
Podophyllin and podophyllotoxin are

mandatory components of
Podophyllum peltatum.
The concentration of podophyllin in
The concentration of podophyllotoxin
10 mg/kg or 10 mg/L or 0.001%.
3862
POGOSTEMON
CABLIN
A,E,H
3863
POLACRILIN
3864
POLACRILIN
POTASSIUM
3865
POLAPREZINC

Zinc is a mandatory component of
Polaprezinc.
dose must be no more than 34
milligrams of zinc sourced from
polaprezinc.
41
Schedule 1

more than 50mg of zinc.
When for internal use and the
maximum recommended daily dose is
more than 25mg but no more than
50mg of zinc, the medicine requires
the medicine label:
- (ZINC) 'WARNING: May be
dangerous if taken in large amounts or
for a long period.' OR 'WARNING:
Contains zinc which may be
for a long period' (or words to that
effect).
3866
POLIGLUSAM
A,E
When used orally, the medicine

- (CHITO) 'Chitosan should be taken
at least one hour after any other
medication as it may reduce the effect
of other medication' (or words to that
effect) AND
(for powdered dosage forms only) 'Do
not take powder alone. Mix with food
or fluid.'
application.
3867
POLLACK-LIVER OIL
A,E
Colecalciferol and Vitamin A are

mandatory components of Pollackliver oil.
42
Schedule 1

maximum daily dose.
use.
use.
43
Schedule 1

D.
medicine label:
balanced diet.
3868
POLLEN

label:
- (POLLEN) 'This medicine can cause
severe allergic reactions' (or words to
that effect).
3869
POLOXAMER

dermal application.
3870
POLOXAMINE

fragrance.
3871
POLOXAMINE 1301

fragrance.
44
Schedule 1

3872
POLY C10-30 ALKYL

ACRYLATE

in the eye.
3873
POLYACRYLAMIDE

dermal application.
Acrylamide is a mandatory component
of Polyacrylamide.
The concentration of Acrylamide in
0.01%.
3874
POLYACRYLATE-1
CROSSPOLYMER

3875
POLYACRYLATE
CROSSPOLYMER-6

3876
POLYACRYLIC ACID
3877
POLYAMINO SUGAR
CONDENSATE

dermal application.
3878
POLYAMINOPROPYL
BIGUANIDE

in the eye.
45
Schedule 1

3879
POLYBUTENE

dermal application.
3880
POLYBUTYLENE
GLYCOL/PPG-9/1
COPOLYMER

in the eye.
3881
POLYCAPROLACTO
NE

in the eye.
3882
POLYDECENE

in the eye.
3883
POLYDEXTROSE
3884
POLYDIETHYLSILO
XANE

3885
POLYDIMETHYL
SILOXANE

printing ink.
46
Schedule 1
3886
POLYESTER-10

in the eye.
3887
POLYESTER-25

3888
POLYESTER-7

in the eye.
3889
POLYESTER-8

in the eye.
The concentration of Polyester-8 must
be no more than 5%.
3890
POLYETHYLENE
3891
POLYGALA
CHINENSIS
A,H
3892
POLYGALA SENEGA
A,E,H
The medicine must have a restricted

flow insert and child resistant closure
fitted onto the container.
3893
POLYGALA
SIBIRICA
A,E,H

root or root bark.
3894
POLYGALA
TENUIFOLIA

root or root bark.
47
Schedule 1
3895
POLYGLYCERYL-10
PENTASTEARATE

in the eye.
3896
POLYGLYCERYL-2PEG-4 STEARATE

dermal application.
3897
POLYGLYCERYL-2
DIISOSTEARATE

in the eye.
3898
3899
POLYGLYCERYL-2
DIPOLYHYDROXYST
EARATE
POLYGLYCERYL-2
TRIISOSTEARATE

dermal application.
in the eye.
3900
POLYGLYCERYL-3
BEESWAX

3901
POLYGLYCERYL-3
DIISOSTEARATE

dermal application.
3902
POLYGLYCERYL-3
DISTEARATE

48
Schedule 1
in the eye.
3903
POLYGLYCERYL-3
METHYLGLUCOSE
DISTEARATE

in the eye.
3904
POLYGLYCERYL-3
POLYDIMETHYLSIL
OXYETHYL
DIMETHICONE

in the eye.
3905
POLYGLYCERYL-3
POLYRICINOLEATE
3906
POLYGLYCERYL-3
STEARATE/ISOSTEA
RATE/DIMER
DILINOLEATE
CROSSPOLYMER
POLYGLYCERYL-4
DIISOSTEARATE/PO
LYHYDROXYSTEAR
ATE/SEBACATE
3907

in the eye.
3908
POLYGLYCERYL-4
ISOSTEARATE

in the eye.
49
Schedule 1

3909
POLYGLYCERYL-4
OLEATE

dermal application.
3910
POLYGLYCERYL-6
POLYRICINOLEATE

in the eye.
3911
POLYGLYCERYL-6
RICINOLEATE

dermal application.
3912
POLYGONATUM
MULTIFLORUM
A,H
3913
POLYGONATUM
OFFICINALE
A,H
3914
POLYGONATUM
SIBIRICUM
A,E,H
3915
POLYGONUM
AVICULARE
A,H
3916
POLYGONUM
BISTORTA
A,H
3917
POLYGONUM
CUSPIDATUM
A,E,H
3918
POLYGONUM
ODORATUM
A,H
3919
POLYHYDROXYSTE
ARIC ACID

dermal application.
3920
POLYISOBUTENE HYDROGENATED

dermal application.
3921
POLYISOBUTYLENE

chewing gum.
50
Schedule 1
The ingredient must comply with the

relevant FCC monograph and
ICH/BP/USP requirements for residual
solvents and catalysts.
3922
POLYISOPRENE

dermal application.
3923
POLYLIMONENE

flavour.
no more than 5%.
3924
POLYMETHACRYLIC
ACID
3925
POLYMETHYL
METHACRYLATE

dermal application.
3926
POLYMETHYLSILSE
SQUIOXANE

in the eye.
3927
POLYPORUS
UMBELLATUS
A,H
3928
POLYPROPYLENE

dermal application.
3929
POLYQUATERNIUM10

dermal application.
3930
POLYQUATERNIUM11

dermal application.
3931
POLYQUATERNIUM22
Only for use in wash-off topical

51
Schedule 1
damaged skin.
3932
POLYQUATERNIUM24

dermal application.
3933
POLYQUATERNIUM28

dermal application.
3934
POLYQUATERNIUM37

in the eye.
3935
POLYQUATERNIUM44

in the eye.
3936
POLYQUATERNIUM51

in the eye.
3937
POLYQUATERNIUM7

dermal application.
3938
POLYSILICONE-11

in the eye.
3939
POLYSILICONE-14
52
Schedule 1

in the eye.
The concentration of Polysilicone-14
3940
POLYSILICONE-15

sunscreens.
dermal application.
3941
POLYSILICONE-2

in the eye.
3942
POLYSORBATE 20
3943
POLYSORBATE 40
3944
POLYSORBATE 60
3945
POLYSORBATE 65
3946
POLYSORBATE 80
3947
POLYSORBATE 85

dermal application.
3948
POLYTEF

in the eye.
3949
POLYURETHANE-34

53
Schedule 1

must be no more than 2% in spray
applications and 6% in non-spray
applications.
3950
POLYVINYL
ACETATE

chewing gum.
3951
POLYVINYL
ACETATE
PHTHALATE
3952
POLYVINYL
ALCOHOL
3953
POLYVINYL
CHLORIDE
3954
POMEGRANATE
3955
PONCEAU SX

topical use.
3956
PONCIRUS
TRIFOLIATA
A,H
When used interally, oxedrine is a

mandatory component of Poncirus
trifoliata.

dermal application.

must be no more than 30 mg.
3957
PONGAMOL

in the eye.
3958
POPPY SEED
E,H
3959
POPPY SEED OIL
E,H
3960
POPULUS ALBA
A,H
54
Schedule 1
3961
POPULUS
BALSAMIIFERA
A,E,H
3962
POPULUS
CANDICANS
A,H
3963
POPULUS
DELTOIDES
A,H
3964
POPULUS NIGRA
A,H
3965
POPULUS TREMULA
A,H
3966
POPULUS
TREMULOIDES
A,H
3967
PORCINE
3968
PORIA COCOS
A,E,H
3969
PORPHYRIDIUM
PURPUREUM
EXTRACT


in the eye.
3970
PORTULACA
OLERACEA
A,E,H
3971
POTASSIUM
ACETATE
3972
POTASSIUM
ARSENITE

ingredient.
3973
POTASSIUM
ASCORBATE
A,E,H

medicine label:
55
Schedule 1
balanced diet.
3974
POTASSIUM
ASCORBATE
DIHYDRATE
A,E,H

medicine label:
balanced diet.
3975
POTASSIUM
ASCORBYL
TOCOPHERYL
PHOSPHATE

dermal application.
3976
POTASSIUM
ASPARTATE
A,E,H

supplementation, potassium is a
mandatory component of potassium
aspartate. The percentage of Potassium
from Potassium aspartate should be
weight of Potassium aspartate.
3977
POTASSIUM
ASPARTATE
DIHYDRATE
A,E,H

supplementation, Potassium is a
aspartate dihydrate.
accepted percentage of potassium from
potassium aspartate dihydrate is
potassium from potassium aspartate
dihydrate must not be less than 17.8%
and must not exceed 19.8% of the
56
Schedule 1
potassium aspartate dihydrate in the

3978
POTASSIUM
ASPARTATE
MONOHYDRATE
A,E

aspartate monohydrate.
accepted percentage of potassium from
potassium aspartate monohydrate is
potassium from potassium aspartate
monohydrate must be no less than
21.7% of the potassium aspartate
monohydrate in the formulation. These
3979
POTASSIUM
BICARBONATE
3980
POTASSIUM
BROMIDE

3981
POTASSIUM
CARBONATE
E,H

3982
POTASSIUM CETYL
PHOSPHATE

dermal application.
3983
POTASSIUM
A,E,H
57
Schedule 1
CHLORIDE

- (POTAS) 'Contains potassium. If you
have kidney disease or are taking heart
or blood pressure medicines - consult
your doctor or pharmacist before use.
Keep out of reach of children.'
When for oral use, the concentration
must be no more than 550 mg per
dosage unit.
Medicines for use as oral rehydration
therapy, are subject to the following
conditions:
a) the medicine complies with the
requirements specified in the British
Pharmacopoeia monograph for Oral
Rehydration Salts;
b) the sodium, potassium and glucose
content, and total osmolarity of the
solution after it has been prepared
according to the instructions on the
packet are consistent with the criteria
specified by the World Health
Organisation (WHO) and the United
Nations Childrens Fund (UNICEF) in
the document 'Expert consultation on
oral rehydration salts formulation' 18
July 2001 and the medicine requires
the warning statements:
- (UOAD) 'Use only as directed'
- (DIAR3) 'If diarrhoea persists, seek
medical advice.'
When for dental use, the concentration
3.75%.
3984
POTASSIUM
CITRATE
A,E,H

58
Schedule 1

citrate.
The percentage of potassium from
Potassium citrate should be calculated
Potassium citrate.
3985
POTASSIUM
COCOYL
HYDROLYSED
COLLAGEN

in the eye.
3986
POTASSIUM
COCOYL
HYDROLYSED SOY
PROTEIN

in the eye.
3987
POTASSIUM
DICHROMATE

ingredient.
3988
POTASSIUM
GLUCONATE
A,E,H

gluconate.
Potassium gluconate should be
weight of Potassium gluconate.
59
Schedule 1

3989
POTASSIUM
GLYCEROPHOSPHA
TE
A,E,H

glycerophosphate.
The percentage of Potassium from
potassium glycerophosphate should be
weight of potassium glycerophosphate.
3990
POTASSIUM
HYDROXIDE

3991
POTASSIUM
HYDROXYCITRATE
A,H

3992
POTASSIUM IODATE

potassium iodate.
The percentage of iodine from
Potassium iodate should be calculated
60
Schedule 1

Potassium iodate.
iodide.
The percentage of potassium in the
potassium iodide.
3993
POTASSIUM IODIDE
A,E,H

potassium iodide.
The percentage of iodine from
Potassium iodide should be calculated
Potassium iodide.
concentration in the medicine
(excluding salts derivatives or
iodophors) is more than 2.5%.
61
Schedule 1

iodide.
Potassium iodide should be calculated
Potassium iodide.
3994
POTASSIUM
METABISULFITE

flavour.
no more than 5%.
3995
POTASSIUM
METAPHOSPHATE

in the eye.
3996
3997
POTASSIUM
NITRATE
A,H
POTASSIUM
OROTATE
A,E,H
Only for dental use.

orotate.
Potassium orotate should be
62
Schedule 1
weight of Potassium orotate.

3998
POTASSIUM
PHOSPHATE DIBASIC
A,E,H

phosphate - dibasic.
Potassium phosphate - dibasic should
weight of Potassium phosphate
dibasic .
3999
POTASSIUM
PHOSPHATE DIBASIC
TRIHYDRATE
A,E,H

phosphate - dibasic trihydrate.
63
Schedule 1
Potassium phosphate - dibasic

trihydrate should be calculated based
on the molecular weight of Potassium
phosphate - dibasic trihydrate.
4000
POTASSIUM
PHOSPHATE MONOBASIC
A,E,H

Potassium phosphate monobasic
molecular weight of Potassium
When used in a solid medicine
containing this ingredient, the pH of a
10 g/L aqueous solution must not be
more than 11.5.
medicine containing this ingredient,
the pH of the medicine must be no
more than 11.5.
4001
POTASSIUM
A,E,H
64
Schedule 1
PHOSPHATE TRIBASIC

phosphate - tribasic.
Potassium phosphate - tribasic should
weight of Potassium phosphate tribasic.
When used in a solid medicine
containing this ingredient, the pH of a
10 g/L aqueous solution must not be
more than 11.5.
medicine containing this ingredient,
the pH of the medicine must be no
more than 11.5.
4002
POTASSIUM
PYROPHOSPHATE
Only for oral application, dental or

topical use.
Not to be included in topical
4003
POTASSIUM
SORBATE

label:
- (SORB8) 'Contains sorbates' (or
word to this effect) if medicine
contains two or more sorbate sources
OR 'Contains [insert the approved
name of sorbate source used]' (or
words to this effect) if medicine
contains one sorbate source.
65
Schedule 1
4004
POTASSIUM
STANNATE

fragrance.
4005
POTASSIUM
STEARATE

dermal application.
4006
POTASSIUM
SULFATE
A,E,H

sulfate.
potassium sulfate should be calculated
potassium sulfate.
4007
POTENTILLA
ANSERINA
A,H
4008
POTENTILLA
CHINENSIS
A,H
4009
POTENTILLA
DISCOLOR
A,H
4010
POTENTILLA
ERECTA
A,E,H
4011
POTENTILLA
REPTANS
A,H
4012
POTERIUM
OFFICINALE
A,E,H
4013
POTERIUM
A,H
66
Schedule 1
SANGUISORBA
4014
POVIDONE
4015
PPG-1-PEG-9
LAURYL GLYCOL
ETHER

in the eye.
4016
PPG-12/SMDI
COPOLYMER

in the eye.
4017
PPG-15 STEARYL
ETHER

in the eye.
4018
PPG-15 STEARYL
ETHER BENZOATE

in the eye.
4019
PPG-17/IPDI/DMPA
COPOLYMER

The concentration of PPG17/IPDI/DMPA Copolymer in the
4020
PPG-2 LANOLIN
67
Schedule 1
ALCOHOL ETHER
4021
PPG-2 MYRISTYL
ETHER PROPIONATE
dermal application.
E

in the eye.
4022
PPG-20 LANOLIN
ALCOHOL ETHER

dermal application.
4023
PPG-20 METHYL
GLUCOSE ETHER

in the eye.
4024
PPG-20 METHYL
GLUCOSE ETHER
DISTEARATE

dermal application.
4025
PPG-3
HYDROGENATED
CASTOR OIL

in the eye.
4026
PPG-3 MYRISTYL
ETHER

dermal application.
4027
PPG-5-CETETH-20

dermal application.
4028
PPG-5LAUROMACROGOL
250

dermal application.
4029
PRALINE

68
Schedule 1

no more than 5%.
4030
PRENYL ACETATE

no more than 5%.
must be no more 1%.
4031
PRICKLY ASH BARK

DRY
A,H
4032
PRICKLY ASH BARK

POWDER
A,H
4033
PRIMULA VERIS
A,E,H
4034
PRIMULA VULGARIS
A,E,H
4035
PRINSEPIA
UNIFLORA
A,H
4036
PROGESTERONE
4037
PROLINE
A,E
4038
PROPAN-1-OL


dermal application.
4039
PROPANE
Only for use as an excipient propellant

ingredient.
4040
PROPENYL
GUAETHOL

69
Schedule 1

no more than 5%.
must be no more 1%.
4041
PROPIONALDEHYDE

no more than 5%.
must be no more 1%.
4042
PROPIONIC ACID

no more than 5%.
must be no more 1%.
4043
PROPIONYLLEVOCA
RNITINE
HYDROCHLORIDE
A,H
4044
PROPOLIS
A,E
Lead is a mandatory component of

Propolis.
The concentration of lead in the
0.001%.
When used topically, the medicine
-(PROP1) 'WARNING: Propolis may
70
Schedule 1
cause skin irritation. Test before use'

When used for other than for topical,
label:
- (PROP2) 'Warning: Propolis may
cause allergic reactions. If irritation or
swelling of the mouth or throat occurs,
discontinue use.'
4045
PROPOLIS BALSAM
A,E

Propolis balsam.
0.001%.
label:
discontinue use.'
4046
PROPOLIS DRY
EXTRACT
A,E

Propolis dry extract.
0.001%.
71
Schedule 1

label:
discontinue use.'
4047
PROPOLIS LIQUID
EXTRACT
A,E

Propolis liquid extract.
0.001%.
label:
discontinue use.'
4048
PROPOLIS RESIN
A,E

propolis resin.
0.001%.
72
Schedule 1

label:
discontinue use.'
4049
PROPOLIS
TINCTURE
A,E

Propolis tincture.
0.001%.
label:
discontinue use.'
4050
PROPYL ACETATE

no more than 5%.
73
Schedule 1
4051
PROPYL CAPROATE

no more than 5%.
4052
PROPYL GALLATE
4053
PROPYL
HYDROXYBENZOAT
E
medicine label:
- (TOTBNZ) Contains
4054
PROPYLENE
CARBONATE
4055
PROPYLENE
GLYCOL
4056
PROPYLENE
GLYCOL ALGINATE

dermal application.

no more than 5%.
4057
PROPYLENE
GLYCOL
DIBENZOATE

dermal application only and not to be
used in topical medicines intended for
use in the eye.
74
Schedule 1
4058
PROPYLENE
GLYCOL
DIDECANOATE

use in the eye.
4059
PROPYLENE
GLYCOL
DIOCTANOATE

dermal application.
4060
PROPYLENE
GLYCOL
DIOCTANOATE/DIDE
CANOATE

dermal application.
4061
PROPYLENE
GLYCOL
DIPELARGONATE

dermal application.
4062
PROPYLENE
GLYCOL
ISOCETETH-3
ACETATE

use in the eye.
4063
PROPYLENE
GLYCOL
ISOSTEARATE

dermal application.
4064
PROPYLENE
GLYCOL
MONOLAURATE

dermal application.
4065
PROPYLENE
GLYCOL
MONOSTEARATE

dermal application.
4066
PROPYLENE
GLYCOL MYRISTYL
ETHER ACETATE

dermal application.
4067
PROSOPIS
A,H
75
Schedule 1
JULIFLORA
4068
PROTEASE
Must be derived from Aspergillus

oryzae.
When the dosage form is undivded,
the units 'haemoglobin unit on the
tyrosine basis per gram' and 'Thousand
haemoglobin units on the tyrosine
basis per gram' are permitted.
When the dosage form is divded, the
units 'haemoglobin units on the
tyrosine basis' and 'thousand
basis' are permitted.
4069
PROTEIN
HYDROLYSATE
4070
PRUNE JUICE

no more than 5%.
4071
PRUNE JUICE
CONCENTRATE

flavour.
no more than 5%.
4072
PRUNELLA
VULGARIS
A,H
4073
PRUNUS AFRICANA
A,E,H

mandatory components of Prunus
africana.
76
Schedule 1

0.0000001%.
4074
PRUNUS
ARMENIACA
A,E,H

armeniaca and must be declared in the
application.
0.0000001%.
4075
PRUNUS AVIUM
A,H

cerasifera.
0.0000001%.
4076
PRUNUS
CERASIFERA
A,E,H

cerasifera.
0.0000001%.
4077
PRUNUS CERASUS
A,E,H

cerasus.
77
Schedule 1

0.0000001%.
4078
PRUNUS
DOMESTICA
A,E,H

domestica.
0.0000001%.
4079
PRUNUS DULCIS
A,E,H

dulcis when the plant part is seed.
When the plant part is seed, the
must be no more than the equivalent of
1mg of the dry seed.
0.0000001%.
4080
PRUNUS HUMILIS
A,E,H

humilis.
78
Schedule 1
0.0000001%.
4081
PRUNUS JAPONICA
A,E,H

japonica.
0.0000001%.
4082
PRUNUS
LAUROCERASUS
A,E,H

laurocerasus.
0.0000001%.
4083
PRUNUS MUME
A,E,H

mume.
0.0000001%.
4084
PRUNUS PERSICA
A,E,H

persica.
79
Schedule 1
0.0000001%.
4085
PRUNUS SALICINA
A,E,H

salicina.
0.0000001%.
4086
PRUNUS SEROTINA
A,E,H

serotina.
0.0000001%.
4087
PRUNUS SPINOSA
A,E,H

spinosa.
0.0000001%.
4088
PRUSSIAN BLUE
4089
PSEUDOCYDONIA
SINENSIS
A,H
4090
PSEUDOSTELLARIA
A,E,H

topical use.
80
Schedule 1
HETEROPHYLLA
4091
PSEUDOTSUGA
MENZIESII
A,H
4092
PSEUDOWINTERA
COLORATA
A,H
4093
PSIDIUM GUAJAVA
A,E,H
4094
PSORALEN (OF
CULLEN
CORYLIFOLIUM)
4095
PSORINUM

4096
PSYLLIUM HUSK
DRY
A,H

label:

leaf.

4097
PSYLLIUM HUSK
POWDER
A,E,H

label:
4098
PSYLLIUM SEED
DRY
A,E,H

label:
4099
PTELEA TRIFOLIATA A,H
4100
PTEROCARPUS
MARSUPIUM
A,H
4101
PTEROCARPUS
A,E,H
81
Schedule 1
SANTALINUS
4102
PUERARIA LOBATA
A,E,H
4103
PUERARIA
MONTANA VAR.
LOBATA
A,E,H
4104
PULLULAN
4105
PUMICE
4106
PUMPKIN
4107
PUMPKIN SEED
E,H
4108
PUMPKIN SEED OIL
E,H
4109
PUNICA GRANATUM
A,E,H
4110
PURE BEE VENOM
4111
PVM/MA
COPOLYMER
4112
PVM/MA
DECADIENE
CROSSPOLYMER

dermal application.
4113
PVP/EICOSENE
COPOLYMER

dermal application.
4114
PVP/HEXADECENE
COPOLYMER

dermal application.
4115
PYRETHRINS

dermal application.


label:
- (PYRTH3) 'Contains pyrethrins' (or
82
Schedule 1
4116
PYRIDOXAL 5PHOSPHATE
A,E
Pyridoxine is a mandatory component

of Pyridoxal 5-phosphate.
accepted percentage of Pyridoxine
from Pyridoxal 5-phosphate is 68.5%.
The declared quantity of Pyridoxine
from Pyridoxal 5-phosphate must be
more than 71.9% of the Pyridoxal 5phosphate in the formulation. These
200mg of pyridoxine.
If the medicine contains more than 50
mg and no more than 200mg of
pyridoxine per maximum
recommended daily dose the medicine
- (VITB6SX) 'WARNING - Stop
taking this medication if you
experience tingling, burning or
numbness and see your healthcare
practitioner as soon as possible.
[Contains vitamin B6]'.
medicine label:
balanced diet.
4117
PYRIDOXAL 5PHOSPHATE
Pyridoxine is a mandatory component

of Pyridoxal 5-phosphate
83
Schedule 1
MONOHYDRATE
monohydrate.
from Pyridoxal 5-phosphate
monohydrate is 63.8%. The declared
quantity of Pyridoxine from Pyridoxal
5-phosphate monohydrate must be no
than 67.12% of the Pyridoxal 5phosphate monohydrate in the
calculations.
medicine label:
balanced diet.
84
Schedule 1
4118
PYRIDOXINE
HYDROCHLORIDE
A,E,H
When not used as an active

homoeopathic ingredient, pyridoxine
Pyridoxine hydrochloride.
from Pyridoxine hydrochloride is
Pyridoxine from Pyridoxine
hydrochloride must be no less than
87.3% of the Pyridoxine hydrochloride
medicine label:
85
Schedule 1
balanced diet.
4119
PYROGLUTAMIC
ACID
4120
PYROLA DECORATA
A,H
4121
PYROLIGNEOUS
ACID

no more than 5%.
4122
PYRROSIA LINGUA
A,H
4123
PYRROSIA
PETIOLOSA
A,H
4124
PYRROSIA
SHEARERI
A,H
4125
PYRUS COMMUNIS
A,E,H
4126
PYRUS PYRIFOLIA
A,H
4127
PYRUVIC ACID

no more than 5%.
4128
QUASSIA

flavour.
no more than 5%.
4129
QUASSIA AMARA
A,E,H
4130
QUASSIA WOOD
JAMAICAN DRY
A,H
86
Schedule 1
4131
QUASSIA WOOD
JAMAICAN POWDER
A,H
4132
QUATERNIUM-15

dermal application.
The medicinerequires the following
label:
- (QUAT15) 'Contains quaternium-15'
4133
QUATERNIUM-18
BENTONITE

dermal application.
4134
QUATERNIUM-18
HECTORITE

dermal application.
4135
QUATERNIUM-52
Only for use in wash-on/wash-off

Not be used in medicines in which Nnitroso compounds may be formed.
4136
QUATERNIUM-80

in the eye.
4137
QUERCETIN
4138
QUERCETIN
DIHYDRATE
4139
QUERCUS
ACUTISSIMA
A,H
4140
QUERCUS ALBA
A,E,H
87
Schedule 1
4141
QUERCUS
PALUSTRIS
A,H
4142
QUERCUS ROBUR
A,H
4143
QUERCUS RUBRA
A,H
4144
QUERCUS
VIRGINIANA
A,H
4145
QUILLAIA DRY
A,H
4146
QUILLAIA POWDER
A,E,H
4147
QUILLAJA
SAPONARIA
A,H
4148
QUINCE
4149
QUININE ARSENITE

Quinine is a mandatory component of
Quinine arsenite.
quinine.
4150
QUININE SULFATE
DIHYDRATE

Quinine is a mandatory component of
quinine sulfate dihydrate.
quinine.
4151
QUINOLINE
YELLOW

and topical use.
4152
QUINOLINE
YELLOW
ALUMINIUM LAKE

and topical use.
4153
QUISQUALIS INDICA
A,H
88
Schedule 1
4154
R-ALPHA LIPOIC
ACID
4155
RACEMENTHOL

no more than 5%.
4156
RACEMIC CAMPHOR
E,H

ingredient.
concentration in the medicine is more
than 2.5%, the nominal capacity of the
mL.
than 2.5% but less than or equal to
container is equal to or less than 25
mL, a restricted flow insert must be
than 10% and the nominal capacity of
the container is more than 15 mL but
less than or euqal to 25 mL, a child
than 10% and the nominal capacity of
the container is less than 15 mL, a
89
Schedule 1
the container.
essential oils, the concentration must
be no more than 2.5%.
In solid and semi solid preparations of
than essential oils, the concentration of
Racemic Camphor must be no more
than 12.5%.
label:
4157
RADISH
E,H

4158
RAISIN

flavour.
no more than 5%.
4159
RAISIN JUICE
CONCENTRATE

no more than 5%.
4160
RANUNCULUS
BULBOSUS
A,H
4161
RANUNCULUS
FICARIA
A,H
4162
RANUNCULUS
TERNATUS
A,H
90
Schedule 1
4163
RAPE OIL/TUNG OIL

COPOLYMER

dermal application and not for use in
the eye.
4164
RAPE SEED OIL
A,E,H

component of Rape seed oil.
isothiocyanate.
4165
RAPHANUS SATIVUS A,H
4166
RASPBERRY
4167
RASPBERRY
BRANDY

flavour.
no more than 5%.
4168
RASPBERRY
DISTILLATE

no more than 5%.
4169
RASPBERRY
ESSENCE

flavour.
no more than 5%.
4170
RASPBERRY JUICE
CONCENTRATE

91
Schedule 1

no more than 5%.
4171
RAUWOLFIA
SERPENTINA
A,H

Rauwolfia serpentina in the medicine
10mg/L or 0.001%.
4172
RAUWOLFIA
SERPENTINA DRY
A,H
The concentration of Rauwolfia

Serpentina Dry in the medicine must
or 0.001%.
4173
RAUWOLFIA
SERPENTINA
POWDER
A,H
The concentration of Rauwolfia

Serpentina Powder in the medicine
10mg/L or 0.001%.
4174
RED 27

and topical use.
4175
RED 27 ALUMINIUM
LAKE

and topical use.
4176
RED ANT

4177
RED CLOVER
FLOWER DRY
A,H
4178
RED CLOVER
FLOWER POWDER
A,H
4179
RED MERCURIC
OXIDE

4180
RED MERCURIC
SULFIDE

4181
REHMANNIA
A,E,H
92
Schedule 1
GLUTINOSA
4182
4183
REL-1-((1R,2S)1,2,3,4,5,6,7,8OCTAHYDRO-1,2,8,8TETRAMETHYL-2NAPHTHALENYL)-1ETHANONE
RESORCINOL

fragrance.
flavour.
no more than 5%.
4184
RESORCINOL
DIMETHYLETHER

flavour.
no more than 5%.
4185
RETINOL
A,E
Vitamin A is a mandatory component

of retinol.
93
Schedule 1

maximum daily dose.
use.
use.
medicine label:
balanced diet.
4186
RETINOL ACETATE
A,E

of retinol acetate.
94
Schedule 1

maximum daily dose.
use.
use.
95
Schedule 1

medicine label:
balanced diet.
4187
RETINOL
PALMITATE
A,E

of retinol palmitate.
maximum daily dose.
96
Schedule 1

use.
use.
medicine label:
balanced diet.'
4188
RHAMNOSE

flavour.
no more than 5%.
4189
RHAMNUS
CATHARTICA
A,H

oral, Hydroxyanthracene derivatives is
a mandatory component of Rhamnus
cathartica.
97
Schedule 1

label:
that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
98
Schedule 1

label:
that effect).
4190
RHAMNUS
FRANGULA
A,H
component of Rhamnus frangula.
label:
that effect)
99
Schedule 1

that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
that effect).
100
Schedule 1
4191
RHATANY ROOT
DRY
A,H
4192
RHATANY ROOT
POWDER
A,H
4193
RHEUM OFFICINALE
A,E,H
The plant part must not be leaf.

oral, Hydroxyanthracene derivatives
calculated as rhein is a mandatory
component of Rheum officinale.
label:
that effect)
that effect).
medicine label:
101
Schedule 1

medicine label:
component(s)]
laxative effect
label:
that effect).
4194
RHEUM PALMATUM
A,E,H

component of Rheum palmatum.
102
Schedule 1
label:
that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
103
Schedule 1
label:
that effect).
4195
RHEUM
RHAPONTICUM
A,E,H

component of Rheum rhaponticum.
label:
that effect)
104
Schedule 1
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
that effect).
4196
RHEUM
TANGUTICUM
A,H

105
Schedule 1

component of Rheum rhaponticum.
label:
that effect)
that effect).
medicine label:
medicine label:
component(s)]
106
Schedule 1

laxative effect
label:
that effect).
4197
RHODAMINE B

topical use.
4198
RHODINOL

no more than 5%.
must be no more 1%.
4199
RHODINYL
ACETATE

flavour.
107
Schedule 1
no more than 5%.

4200
RHODIOLA ROSEA

Only available for use when the plant
preparation is dry root powder, dry
root powder as an aqueous extract or
dry root powder as a hydroethanolic
extract with no more than 70% ethanol
v/v.
4201
RHODODENDRON
AUREUM
A,H
4202
RHODODENDRON
FERRUGINEUM
A,H
4203
RHODODENDRON
MOLLE
A,H
4204
RHODYMENIA
PALMATA
A,H
4205
RHUBARB
E,H

dose of the medicine must be no more
than 1mg of the dry herbal material.

or excipient ingredent.
oral, Hydroxyanthracene derivatives is
a mandatory component of Rhubarb.
label:
108
Schedule 1

that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
109
Schedule 1

that effect).
4206
RHUBARB ROOT
DRY
A,H

component of Rhubarb Root Dry.
label:
that effect)
that effect).
medicine label:
110
Schedule 1

medicine label:
component(s)]
laxative effect
label:
that effect).
4207
RHUBARB ROOT
POWDER
A,H

component of Rhubarb Root Powder.
label:
111
Schedule 1

that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
112
Schedule 1

that effect).
4208
RHUS AROMATICA
A,E,H
4209
RHUS CHINENSIS
A,H
4210
RHUS GLABRA
A,E,H
4211
RHUS VENENATA
4212
RIBES
GROSSULARIA
A,E,H
4213
RIBES NIGRUM
A,E,H
4214
RIBOFLAVIN
A,E

ingredient.

medicine label:
balanced diet.
4215
RIBOFLAVIN
SODIUM
PHOSPHATE
A,E

113
Schedule 1

medicine label:
balanced diet.
4216
RIBOFLAVIN
TETRAACETATE

dermal application.
4217
RIBOFLAVINE
A,E
4218
RIBOFLAVINE
SODIUM
PHOSPHATE
A,E
4219
RIBONUCLEIC ACID

dermal application.
4220
RIBOSE

label:
more sugars.
114
Schedule 1

label:
to that effect).
4221
RICE
4222
RICE HYDROLYSED
A,E,H
4223
RICE BRAN
4224
RICE BRAN OIL
4225
RICE BRAN WAX
A,E,H
4226
RICE VINEGAR
4227
RICE WINE

Rice wine.
label:
contains alcohol
4228
RICINOLEIC ACID

dermal application.
4229
RICINUS COMMUNIS
A,H
Only for use when the plant part must

be seed and the plant preparation is oil
fixed.
4230
ROBINIA
PSEUDOACACIA
A,E,H

from plant parts other than the leaf or
flower, the maximum recommended
daily dose of the medicine must be no
more than 1mg of the dry herbal
material.
4231
ROHDEA JAPONICA
A,H

115
Schedule 1

material.
4232
ROSA ARVENSIS
A,E,H
4233
ROSA CANINA
A,E,H
4234
ROSA CYMOSA
A,E,H
4235
ROSA EGLANTERIA
A,E,H
4236
ROSA GALLICA
A,E,H
4237
ROSA LAEVIGATA
A,E,H
4238
ROSA MULTIFLORA
A,E,H
4239
ROSA ROXBURGHII
FRUIT EXTRACT

in the eye.
4240
ROSA RUGOSA
A,E,H
4241
ROSA VILLOSA
A,E,H
4242
ROSA X CENTIFOLIA
A,E,H
4243
ROSA X
DAMASCENA
A,E,H
4244
ROSANA

fragrance.
4245
ROSE ABSOLUTE

116
Schedule 1
no more than 5%.

must be no more 1%.
4246
ROSE FRUIT FRESH
A,E,H
4247
ROSE HIP
4248
ROSE OIL
A,E,H
4249
ROSE OXIDE

no more than 5%.
must be no more 1%.
4250
ROSEMARY OIL
A,E,H

Rosemary oil.
4251
ROSMARINUS
OFFICINALIS
A,E,H
Camphor and cineole are mandatory

components of Rosmarinus officinalis.
no more than 12.5%.
117
Schedule 1

label:
118
Schedule 1

medicine label:
4252
ROYAL JELLY
A,E
10-Hydroxy-2-decenoic acid is a
mandatory component of Royal jelly.
label:
- (CHILD2) 'Not suitable for children'
- (ROYJ) 'Not to be taken by asthma
and allergy sufferers' in 3 mm type,
prominent on front and 'This product
contains royal jelly which has been
reported to cause severe allergic
reactions and in rare cases fatalities,
especially in asthma and allergy
119
Schedule 1
sufferers'.
4253
ROYAL JELLY
FRESH
A,E
mandatory component of Royal jelly
fresh.
label:
sufferers'.
4254
ROYAL JELLY
LYOPHILISED
A,E
mandatory component of Royal jelly
lyophilised.
label:
sufferers'.
4255
RUBBER NATURAL
4256
RUBIA CORDIFOLIA
A,H
4257
RUBIA TINCTORUM
A,H

dermal application.
120
Schedule 1
4258
RUBUS CHINGII
A,H
4259
RUBUS
CORCHORIFOLIUS
A,H
4260
RUBUS COREANUS
A,E,H
4261
RUBUS FRUTICOSUS
A,E,H
4262
RUBUS IDAEUS
A,E,H
4263
RUBUS
OCCIDENTALIS
A,E,H
4264
RUBUS
PARVIFOLIUS
A,H
4265
RUBUS ROSIFOLIUS
A,H
4266
RUDBECKIA HIRTA
A,H
4267
RUE OIL
A,H
4268
RUM

no more than 5%.
4269
RUMEX ACETOSA
A,H
4270
RUMEX
ACETOSELLA
A,H
4271
RUMEX
CONGLOMERATUS
A,H
4272
RUMEX CRISPUS
A,E,H
4273
RUMEX PULCHER
A,H
4274
RUMEX SCUTATUS
A,H
4275
RUSCUS
ACULEATUS
A,H
121
Schedule 1
4276
RUTA GRAVEOLENS
A,E,H
4277
RUTOSIDE
A,E
4278
RYE

Rye when the route of administration
is other than topical and mucosal.
label:
4279
RYE BRAN

Rye bran when the route of
mucosal.
label:
4280
S-ISOPROPYL 3METHYLTHIOCROT
ONATE

fragrance.
4281
SABINENE
HYDRATE

flavour.
no more than 5%.
122
Schedule 1
4282
SACCHARIN

label:
- (SACCH) 'Contains saccharin' (or
4283
SACCHARIN
SODIUM

label:
- (SACCH) 'Contains saccharin' (or
4284
SACCHAROMYCES
CEREVISIAE
A,E

no more than 1%.
4285
SACCHAROMYCES
CEREVISIAE
(BOULARDII)

no more than 1%.
4286
SACCHAROMYCES
CERVISIAE
POLYSACCHARIDES

in the eye.
4287
SACCHAROMYCES/Z
INC FERMENT
4288
SACCHARUM
A,E,H

dermal application.
123
Schedule 1
OFFICINARUM
4289
SAFFLOWER OIL
A,E,H
4290
SAFFRON

and topical use.
4291
SAGE LEAF DRY
A,E,H

Sage leaf dry.
4292
SAGE LEAF POWDER
A,H

Sage leaf powder.
4293
SAGE OIL
DALMATIAN

Sage oil dalmation.
When the concentration of Sage oil
dalmatian in the medicine is more than
container is no more than 15 mL, a
restricted flow insert and child
resistant closure must be fitted on the
container and the medicine requires
the medicine label:
4294
SAGE OIL SPANISH
A,E,H
4295
SALICORNIA
EUROPAEA
EXTRACT

dermal use and not to be included in
medicines intended for use in the eye
or on damaged skin.
124
Schedule 1

4296
SALICYLALDEHYDE

no more than 5%.
must be no more 1%.
4297
SALICYLIC ACID
E,H
4298
SALIX ALBA
A,E,H
4299
SALIX DAPHNOIDES
A,H
4300
SALIX DISCOLOR
A,H
4301
SALIX FRAGILIS
A,H
4302
SALIX NIGRA
A,H
4303
SALIX PURPUREA
A,H
4304
SALSOLA KALI
A,H
4305
SALVIA CHINENSIS
A,H
4306
SALVIA FRUTICOSA
A,H
4307
SALVIA HISPANICA
A,E,H
4308
SALVIA
LAVANDULAEFOLIA
A,H
4309
SALVIA
MILTIORRHIZA
A,H
4310
SALVIA
OFFICINALIS
A,E,H

dermal application.

Salvia officinalis.
125
Schedule 1
4311
SALVIA SCLAREA
A,E,H
4312
SAMBUCUS
CANADENSIS
A,H
4313
SAMBUCUS EBULUS
A,H
4314
SAMBUCUS NIGRA
A,E,H
4315
SANDALWOOD OIL
EAST INDIAN
A,E,H
4316
SANGUINARIA
CANADENSIS

The potency must be more than 4X.
4317
SANICULA
EUROPAEA
A,H
4318
SANTALUM ALBUM
A,E,H
4319
SANTALUM
SPICATUM
A,E,H
The route of administration must be

topical or inhalation.
The plant preparation must be oil.
The plant part must be root or stem
wood including heartwood.
4320
SAPINDUS
MUKOROSSI
A,H
4321
SAPONARIA
OFFICINALIS
A,H
4322
SAPOSHNIKOVIA
DIVARICATA
A,H
4323
SARCOSINE

in the eye.
4324
SARGASSUM
A,H
126
Schedule 1
FUSIFORME
Sargassum fusiforme.
4325
SARGASSUM
SILIQUASTRUM
A,H

Sargassum siliquastrum.
4326
SASSAFRAS
ALBIDUM
A,H

Sassafras albidum.
127
Schedule 1
4327
SATUREIA
HORTENSIS
A,H
4328
SATUREIA
MONTANA
A,H
4329
SAUROPUS
SPATULIFOLIUS
A,H
4330
SAURURUS
CHINENSIS
A,H
4331
SAUSSUREA
COSTUS
A,H
4332
SAVORY OIL
SUMMER
A,H
4333
SAXIFRAGA
GRANULATA
A,E,H
4334
SCAPHIUM
SCAPHIGERUM
A,H
4335
SCHEFFLERA
HEPTAPHYLLA
A,H
4336
SCHINOPSIS
QUEBRACHOCOLORADO
A,H
4337
SCHINUS MOLLE
A,H
4338
SCHINUS MOLLE
OIL

fragrance.
4339
SCHISANDRA
CHINENSIS
A,E,H
4340
SCHIZONEPETA
TENUIFOLIA
A,E,H
128
Schedule 1
4341
SCHOENOCAULON
OFFICINALE
A,H

dose must contain no more than the
material.
4342
SCLAREOL

flavour.
no more than 5%.
4343
SCLAREOLIDE

fragrance.
4344
SCLERANTHUS
ANNUUS
A,H
4345
SCLEROTIUM GUM

dermal application.
4346
SCOPOLIA
CARNIOLICA
A,H

Scopolia carniolica in the medicine
10mg/L or 0.001%.
4347
SCROPHULARIA
NINGPOENSIS
A,H
4348
SCROPHULARIA
NODOSA
A,H
4349
SCURRULA
PARASITICA VAR.
GRACILIFLORA
A,H
4350
SCUTELLARIA
BAICALENSIS
A,E,H
4351
SCUTELLARIA
A,H
129
Schedule 1
BARBATA
4352
SCUTELLARIA
LATERIFLORA
A,E,H
4353
SEA WHIP EXTRACT

in the eye.
4354
SEC-BUTYL
THIOISOVALERATE

fragrance.
4355
SEC BUTYL 3METHYLBUT-2ENETHIOATE

fragrance.
4356
SECALE CEREALE
A,H

Secale cereale when the plant part is
label:
4357
SEDUM ACRE
A,H
4358
SELAGINELLA
A,H
130
Schedule 1
TAMARISCINA
4359
SELENICEREUS
GRANDIFLORUS
A,E,H
4360
SELENIUM

Oral medicines must contain no more
than 150 micrograms of selenium per
- (SELE) 'This medicine contains
selenium which is toxic in high doses.
A daily dose of 150 mcg for adults of
selenium from dietary supplements
should not be exceeded.'
4361
SELENOCYSTEINE
Selenium is a mandatory component

of Selenocysteine for oral and
sublingual use.
The percentage of selenium from
Selenocysteine should be calculated
Selenocysteine.
131
Schedule 1

4362
SELENOMETHIONIN
E

of Selenomethionine for oral and
sublingual use.
Selenomethionine should be calculated
Selenomethionine.
should not be exceeded.
'The indication For mineral (may state
4363
SEMECARPUS
ANACARDIUM
A,H
4364
SEMOLINA
4365
SEMPERVIVUM
TECTORUM
A,H
4366
SENEGA ROOT DRY
A,H
4367
SENEGA ROOT
POWDER
A,H
When the plant part is other than seed,

132
Schedule 1
4368
SENNA
ALEXANDRINA
A,H

mandatory component of Senna
alexandrina.
label:
that effect)
that effect).
medicine label:
medicine label:
133
Schedule 1

component(s)]
laxative effect
label:
that effect).
4369
SENNA FRUIT
ALEXANDRIAN DRY
A,H

mandatory component of Senna Fruit
Alexandrian Dry.
label:
134
Schedule 1

that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
135
Schedule 1

that effect).
4370
SENNA FRUIT
ALEXANDRIAN
POWDER
A,H

Alexandrian Powder.
label:
that effect)
that effect).
medicine label:
136
Schedule 1

medicine label:
component(s)]
laxative effect
label:
that effect).
4371
SENNA FRUIT
TINNEVELLY DRY
A,H

Tinnevelly Dry.
137
Schedule 1

label:
that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
138
Schedule 1

label:
that effect).
4372
SENNA FRUIT
TINNEVELLY
POWDER
A,H
When for oral or sublingual,

Tinnevelly Powder.
label:
that effect)
139
Schedule 1
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
that effect).
4373
SENNA LEAF DRY
A,H

140
Schedule 1
mandatory component of Senna Leaf

Dry.
label:
that effect)
that effect).
medicine label:
medicine label:
component(s)]
141
Schedule 1
laxative effect
label:
that effect).
4374
SENNA LEAF
POWDER
A,H

mandatory component of Senna Leaf
Powder.
label:
142
Schedule 1

that effect)
that effect).
medicine label:
medicine label:
component(s)]
laxative effect
label:
143
Schedule 1

that effect).
4375
SENNA TORA
A,H

mandatory component of Senna tora.
label:
that effect)
that effect).
medicine label:
144
Schedule 1
medicine label:
component(s)]
laxative effect
label:
that effect).
4376
SEPIA
4377
SEQUOIA
SEMPERVIRENS
A,H
4378
SEQUOIADENDRON
GIGANTEUM
A,H
4379
SERENOA REPENS
A,H
4380
SERINE
A,E
4381
SERUM ANGUILLAE


145
Schedule 1
4382
SESAME OIL
A,E,H
4383
SESAME SEED
4384
SESAMUM INDICUM
A,E,H
4385
SETARIA ITALICA
A,H
4386
SHARK-LIVER OIL
A,E
Vitamin A and Colecalciferol are

mandatory components of Shark-liver
oil. When for internal use, the
must be no more than 25 micrograms
of vitamin D.
maximum daily dose.
146
Schedule 1

use.
use.
medicine label:
balanced diet.
4387
SHARK CALCIUM
CHONDROITIN
SULFATE
4388
SHARK CARTILAGE
A,E

label:
- (SHARK) 'Children, pregnant or
breastfeeding women, and those who
have recently had a heart attack,
147
Schedule 1
surgery or a major accident should not

consume this product without medical
advice' (or words to that effect)
4389
SHARK POTASSIUM
CHONDROITIN
SULFATE
4390
SHEA BUTTER
4391
SHEA BUTTER
UNSAPONIFIABLES
4392
SHELLAC
4393
SHEPHERD'S PURSE
HERB DRY
A,H
4394
SHEPHERD'S PURSE
HERB POWDER
A,H
4395
SHERRY WINE

dermal application.

no more than 5%.
4396
SIGESBECKIA
ORIENTALIS
A,E,H
4397
SILICA

no more than 5%.
4398
SILICA - COLLOIDAL
ANHYDROUS
A,E,H

4399
SILICA DIMETHYL
SILYLATE

in the eye.
148
Schedule 1

4400
SILICA SILYLATE

dermal application.
4401
SILICEOUS EARTH PURIFIED
E,H

4402
SILICON DIOXIDE
A,E,H

4403
SILICONE
QUATERNIUM-8

label:
4404
SILVER

4405
SILVER BEET
E,H
4406
SILVER
BOROSILICATE

in the eye.
should be no more than 0.6%.
149
Schedule 1
Silver is a mandatory component of

Silver borosilicate when the route of
administration is topical.
The concentration of silver in the
4407
SILVER NITRATE
4408
SILYBUM
MARIANUM
A,E,H
4409
SIMABA CEDRON
A,H
4410
SIMETHICONE
4411
SIMMONDSIA
CHINENSIS
A,E,H
4412
SINAPIS ALBA
A,H


component of Sinapis alba when the
plant part is seed.
from the seed then the maximum
isothiocyanate.
4413
SINAPIS ARVENSIS
A,H
4414
SINOMENIUM
ACUTUM
A,H
4415
SIPHONESTEGIA
CHINENSIS
A,H
4416
SIRAITIA
GROSVENORII
A,E,H
4417
SISYMBRIUM
OFFICINALE
A,H
4418
SKATOLE

150
Schedule 1

no more than 5%.
must be no more 1%.
4419
SKIPJACK-LIVER OIL
A,E
Vitamin A and Colecalciferol are

mandatory components of Skipjackliver oil. When for internal use, the
must be no more than 25 micrograms
of vitamin D.
maximum daily dose.
151
Schedule 1

use.
use.
medicine label:
balanced diet.
4420
SLIPPERY ELM
BARK DRY
A,H
4421
SLIPPERY ELM
BARK POWDER
A,E,H
4422
SMILAX
ARISTOLOCHIIFOLI
A
A,H
152
Schedule 1
4423
SMILAX CHINA
A,H
4424
SMILAX GLABRA
A,H
4425
SMILAX
OFFICINALIS
A,E,H
4426
SMILAX ORNATA
A,E,H
4427
SMOKE EXTRACT

flavour.
no more than 5%.
4428
SNAKE - BLACK

ingredient.
4429
SNAKE BUSHMASTER

ingredient.
4430
SNAKE - TAIPAN

ingredient.
4431
SNAKE - TIGER

ingredient.
4432
SODIUM ACETATE

4433
SODIUM
ACETYLATED
HYALURONATE

in the eye.
153
Schedule 1

4434
SODIUM ACID
CITRATE
A,E,H

only for use in oral medicines.
When used as an active, only for use
in oral medicines.
4435
SODIUM
ACRYLATES
COPOLYMER

in the eye.
4436
SODIUM
ACRYLATES
CROSSPOLYMER-2

must be no more than 0.7 % (w/w).
4437
SODIUM
ACRYLOYDIMETHY
LTAURATE/VP
CROSSPOLYMER

must be no more than 2% (w/w).
4438
SODIUM ALGINATE
154
Schedule 1
4439
SODIUM
ASCORBATE
A,E,H

mineral supplementation, the
equivalent quantity of sodium is
required in the application and also on
the product label.
accepted percentage of sodium from
sodium ascorbate is 11.6%. The
declared quantity of sodium from
sodium ascorbate must be no less than
11% and must be no more than 12.2%
of the sodium ascorbate in the
calculations.
medicine label:
balanced diet.
4440
SODIUM ASCORBYL
PHOSPHATE

155
Schedule 1
in the eye.
When used in a sunscreen, the
no more than 0.1%.
When used in products other than
sunscreens, the concentration in the
4441
SODIUM
ASCORBYL/CHOLES
TERYL PHOSPHATE

in the eye.
4442
SODIUM BENZOATE

- (TBNZO8) Contains benzoates' (or
or Contains [insert the approved name
of benzoate used] (or words to this
benzoate source.
4443
SODIUM BETAHYDROXY-BETAMETHYLBUTYRATE
A,H

156
Schedule 1

4444
SODIUM BETAHYDROXY-BETAMETHYLBUTYRATE
MONOHYDRATE
A,H
4445
SODIUM
BICARBONATE
A,E

medicine may only be for oral
rehydration salts in powdered and
effervescent tablet dosage forms.
Medicines for use as oral rehydration
therapy are subject to the following
conditions:
a) the medicine complies with the
requirements specified in the British
Pharmacopoeia monograph for Oral
Rehydration Salts;
b) the sodium, potassium and glucose
content, and total osmolarity of the
solution after it has been prepared
according to the instructions on the
packet are consistent with the criteria
specified by the World Health
Organisation (WHO) and the United
157
Schedule 1
Nations Childrens Fund (UNICEF) in

the document 'Expert consultation on
oral rehydration salts formulation' 18
July 2001.
label:
- (UOAD) 'Use only as directed'
- (DIAR) 'If diarrhoea persists for
more than 6 hours in infants under 6
months - 12 hours in children under 3
years - 24 hours in children aged 3-6
years or 48 hours in adults and
children over 6 years - seek medical
advice' (or words to that effect)
- (DIAR3) 'If diarrhoea persists, seek
medical advice.'
- (POTAS) 'Contains potassium. If you
have kidney disease or are taking heart
or blood pressure medicines - consult
your doctor or pharmacist before use.
Keep out of reach of children'.
4446
SODIUM BISULFITE

Medicines containing sulfites salts
- (SULF) 'Contains sulfites' (or words
to this effect) if medicine contains two
158
Schedule 1
or more sulfite sources or 'Contains

(insert the approved name of sulfites
used)' (or words to this effect) if
medicine contains one sulfite source.
4447
SODIUM BROMIDE

ingredient.
4448
SODIUM C14-16
OLEFIN SULFONATE

dermal application.
4449
SODIUM
CARBONATE

4450
SODIUM
CARBONATE
MONOHYDRATE
E,H

159
Schedule 1

4451
SODIUM
CARBOXYMETHYL
BETAGLUCAN

in the eye.
4452
SODIUM
CARRAGEENAN
4453
SODIUM CASEINATE

no more than 5%.
must be no more 1%.
4454
SODIUM
CETOSTEARYL
SULFATE

dermal application.
4455
SODIUM CHLORIDE
A,E,H

supplementation, sodium is a
mandatory component of Sodium
chloride. The percentage of sodium
from Sodium chloride should be
calculated on the molecular weight of
Sodium chloride. If used as an active
ingredient and the medicine is
intended as a mineral supplementation,
the equivalent quantity of sodium is
required in the application and also on
the product label.
160
Schedule 1

4456
SODIUM
CHONDROITIN
SULFATE

in the eye.
4457
SODIUM CITRATE
A,E
Only for oral use when used as an

active ingredient.
4458
SODIUM CITRATE
A,E
Only for oral use when used as an
161
Schedule 1
DIHYDRATE
active ingredient.
4459
SODIUM COCO PGDIMONIUM

CHLORIDE
PHOSPHATE

in the eye.
4460
SODIUM
COCOAMPHOACETA
TE

dermal application.
4461
SODIUM COCOYL
SARCOSINATE

dermal application.
4462
SODIUM
CYCLAMATE

4463
SODIUM
DEHYDROACETATE

dermal application.
Medicines containing the
antimicrobial preservative sodium
dehydroacetate require the following
162
Schedule 1

label:
- (SDACET) 'Contains sodium
dehydroacetate' (or words to that
effect).
4464
SODIUM DNA

in the eye.
4465
4466
SODIUM
DODECYLBENZENE
SULFONATE
SODIUM
ERYTHORBATE

dermal application.
4467
SODIUM ETHYL
HYDROXYBENZOAT
E
4468
SODIUM FLUORIDE
A,E,H
Fluoride is a mandatory component of

Sodium fluoride.
accepted percentage of fluoride from
sodium fluoride is 45.25%. The
declared quantity of fluoride from
sodium fluoride must not be less than
43.0% and must not exceed 47.5% of
the sodium fluoride in the formulation.
163
Schedule 1

calculations.
administration is dental and the dosage
form is pastes, powders or gels for
dental hygiene.
subject to the following conditions:
a) Only for use in combination with at
least one other listable therapeutically
active ingredient.
b) The concentration of fluoride ion
must be no more than 1,500 mg/kg.
c) When the concentration of fluoride
ion is more than 1,000 mg/kg, any
claims made regarding the medicine in
relation to fluoride content are
restricted to those relating to
improvements in dental hygiene or the
use of fluoride for the prevention of
tooth decay.
In products, other than dental
products, the concentration of fluoride
in the product from all ingredients
must not exceed 15 mg/kg or 15 mg/L
or 0.0015%.
164
Schedule 1
4469
SODIUM FUMARATE

4470
SODIUM
GLYCEROPHOSPHA
TE
A,E,H

4471
SODIUM
HYALURONATE

dermal application.
4472
SODIUM
HYDROGENATED
TALLOW
GLUTAMATE

dermal application.
4473
SODIUM
HYDROXIDE

165
Schedule 1

4474
SODIUM
HYDROXYCITRATE

4475
SODIUM
HYDROXYETHYL
ACRYLATE/ACRYLO
YLDIMETHYL
TAURATE
COPOLYMER

in the eye.
4476
SODIUM
HYDROXYMETHYL
GLYCINATE

dermal application.
4477
SODIUM
HYPOCHLORITE
E,H


Chlorine is a mandatory component of

Sodium hypochlorite.
The concentration of chlorine in the
166
Schedule 1

4478
SODIUM
ISOSTEAROYL
LACTYLATE

dermal application.
4479
SODIUM LACTATE

4480
SODIUM LAURETH
SULFATE

4481
SODIUM
LAUROAMPHOACET
ATE

in the eye.
167
Schedule 1

4482
SODIUM LAUROYL
METHYL
ISETHIONATE

damaged skin.
4483
SODIUM LAUROYL
SARCOSINATE

dermal application.
4484
SODIUM LAURYL
PHOSPHATE

4485
SODIUM LAURYL
SULFATE

4486
SODIUM LAURYL
SULFOACETATE

dermal application.
4487
SODIUM
MAGNESIUM
SILICATE

dermal application.
4488
SODIUM MANNOSE

168
Schedule 1
PHOSPHATE

in the eye.
4489
SODIUM
METABISULFITE

4490
4491
SODIUM METHYL
COCOYL TAURATE
SODIUM METHYL
HYDROXYBENZOAT
E
Only for dental use.

169
Schedule 1

medicine label:
- (TOTBNZ) Contains
4492
SODIUM
MOLYBDATE
DIHYDRATE

component of Sodium molybdate
dihydrate.
accepted percentage of molybdenum
from Sodium molybdate dihydrate is
molybdenum from Sodium molybdate
dihydrate must be no less than 37.7%
the Sodium molybdate dihydrate in the
calculations.
molybdenum from Sodium molybdate
dihydrate must be no more than 125
micrograms.
4493
SODIUM
MONOFLUOROPHOS
PHATE
Fluoride is a mandatory component of

sodium monofluorophosphate.
administration is dental and the dosage
form is pastes, powders or gels for
dental hygiene.
170
Schedule 1
subject to the following conditions:

a) Only for use in combination with at
least one other listable therapeutically
active ingredient.
b) The concentration of fluoride ion
must be no more than 1,500 mg/kg.
c) When the concentration of fluoride
ion is more than 1,000 mg/kg, any
claims made regarding the medicine in
relation to fluoride content are
restricted to those relating to
improvements in dental hygiene or the
use of fluoride for the prevention of
tooth decay.
In products, other than dental
products, the concentration of fluoride
in the product from all ingredients
must not exceed 15 mg/kg or 15 mg/L
or 0.0015%.
- (SODIUM) 'The recommended daily
quantity and units] of sodium' (or
4494
SODIUM
MYRISTOYL
GLUTAMATE

in the eye.
4495
SODIUM NITRATE

171
Schedule 1
4496
SODIUM
NONOXYNOL-4
SULFATE

dermal application.
4497
SODIUM
PANTOTHENATE
A,E,H

4498
SODIUM PCA

dermal application.
4499
SODIUM
PERBORATE
A,H

sodium perborate.
The percentage of boron from sodium
perborate should be calculated based
on the molecular weight of sodium
perborate.
provide more than 6 mg of boron.
When used preparations for dermal
use, which are not for paediatric or
antifungal use, the concentration of
boron from all ingredients in the
product must not exceed 3500 mg/kg
or 3500 mg/L or 0.35%.
172
Schedule 1

4500
SODIUM
PERCARBONATE

dermal application.
4501
SODIUM
PHOSPHATE MONOBASIC
DIHYDRATE

4502
SODIUM
PHOSPHATE TRIBASIC

173
Schedule 1

4503
SODIUM
POLYACRYLATE
4504
SODIUM
POLYMETAPHOSPH
ATE
4505
SODIUM
PROPIONATE

dermal application.

dermal application.
Medicines for topical use containing
the antimicrobial preservative sodium
propionate requires the following
label:
- (SPROP) 'Contains sodium
propionate' (or words to that effect).
4506
SODIUM PROPYL
HYDROXYBENZOAT
E

174
Schedule 1

medicine label:
- (TOTBNZ) Contains
4507
SODIUM RNA

in the eye.
4508
SODIUM SELENATE
A,H

of sodium selenite.
Sodium selenite should be calculated
Sodium selenite.
175
Schedule 1

4509
SODIUM SELENITE
A,H

of Sodium selenite.
Sodium selenite should be calculated
Sodium selenite.
4510
SODIUM SELENITE
PENTAHYDRATE
A,H

of Sodium selenite pentahydrate.
sodium selenite pentahydrate should
weight of sodium selenite
pentahydrate.
176
Schedule 1

4511
SODIUM SILICATE

4512
SODIUM STARCH
GLYCOLLATE

4513
SODIUM STARCH
177
Schedule 1
GLYCOLLATE TYPE
A

4514
SODIUM STEARATE

dermal application.
4515
SODIUM STEAROXY
PGHYDROXYETHYLCE
LLULOSE
SULFONATE

in the eye.
SODIUM STEAROYL
GLUTAMATE
4516

in the eye.
4517
SODIUM STEAROYL
LACTYLATE

dermal application.
4518
SODIUM STEARYL
PHTHALAMATE
Only for use in medicines medicines

for dermal application and not to be
use in the eye.
4519
SODIUM SUCCINATE

dermal application.
4520
SODIUM SULFATE
A,E,H

178
Schedule 1
mandatory component of sodium

sulfate.
When it is not intended to be a
medicine label:
- (LAX4) 'Substance may have a
laxative effect'.
4521
SODIUM SULFATE
DECAHYDRATE
A,E,H

mandatory component of sodium
sulfate decahydrate.
When it is not intended to be a
medicine label:
- (LAX4) 'Substance may have a
laxative effect'.
179
Schedule 1

4522
SODIUM SULFITE
E,H

4523
SODIUM SULFITE
HEPTAHYDRATE

dermal application.
4524
SODIUM
TRIPOLYPHOSPHAT
E

administration is topical for dermal
application, mucous membrane
180
Schedule 1
(buccal mucosa) or dental.

Not to be included in topical
4525
SOLANUM
DULCAMARA
A,H
When for internal use, steroidal

alkaloids calculated as solamine is a
mandatory component of Solanum
dulcamara.
provide more than 10mg of steroidal
4526
SOLANUM FEROX
A,H

ferox.
4527
SOLANUM
LYCOCARPUM
FRUIT EXTRACT

dermal use and not to be included in
the eye.
4528
SOLANUM
MELONGENA
A,H

melongena.
181
Schedule 1
4529
SOLANUM NIGRUM
A,H

nigrum.
4530
SOLANUM
TUBEROSUM
A,H

tuberosum.
4531
SOLIDAGO
GIGANTEA
A,H
4532
SOLIDAGO
GIGANTEA MIS
A,E,H
4533
SOLIDAGO
VIRGAUREA
A,E,H
4534
SOLVENT GREEN 3

topical use.
4535
SOLVENT RED 1

topical use.
4536
SOLVENT VIOLET 13

topical use.
4537
SOLVENT YELLOW
172

topical use.
4538
SOLVENT YELLOW
33

topical use.
182
Schedule 1
4539
SOPHORA
FLAVESCENS
A,E,H
4540
SOPHORA
TONKINENSIS
A,H
4541
SORBIC ACID

label:
- (SORB8) 'Contains sorbates' (or
word to this effect) if medicine
contains two or more sorbate sources
OR 'Contains [insert the approved
name of sorbate source used]' (or
words to this effect) if medicine
contains one sorbate source.
4542
SORBITAN
ISOSTEARATE
4543
SORBITAN MONOOLEATE
4544
SORBITAN
MONOLAURATE
4545
SORBITAN
MONOSTEARATE
4546
SORBITAN OLEATE
4547
SORBITAN OLIVATE

dermal application.

in the eye.
4548
SORBITAN
PALMITATE

183
Schedule 1

4549
SORBITAN
SESQUIISOSTEARAT
E

dermal application.
4550
SORBITAN
SESQUIOLEATE

dermal application.
4551
SORBITAN
STEARATE
4552
SORBITAN
TRISTEARATE

dermal application.
4553
SORBITOL
A,E

medicine label:
4554
SORBITOL
SOLUTION (70 PER
CENT)
(CRYSTALLISING)
A,E
Sorbitol is a mandatory component of

Sorbitol solution (70 per cent)
(crystallising).
184
Schedule 1
4555
SORBITOL
SOLUTION (70 PER
CENT) (NONCRYSTALLISING)
A,E
4556
SORBUS
AUCUPARIA
A,H
4557
SORBUS
DOMESTICA
A,H
4558
SORGHUM
4559
SORGHUM
VULGARE
A,H
4560
SOY
POLYSACCHARIDE
4561
SOY PROTEIN
4562
SOY PROTEIN HYDROLYSED
Sorbitol is a mandatory component of

Sorbitol solution (70 per cent) (noncrystallising).

dermal application not to be included
in the eye.
4563
SOY STEROL
4564
SOYA BEAN
4565
SOYA BRAN
4566
SOYA OIL
A,E,H
4567
SOYA OIL HYDROGENATED
4568
SOYA OIL PARTIALLY

185
Schedule 1
HYDROGENATED
flavour.
no more than 5%.
4569
SOYBEAN FLOUR

no more than 5%.
4570
SOYBEAN
GLYCERIDES

in the eye.
4571
SPARGANIUM
STOLONIFERUM
A,H
4572
SPARTIUM
JUNCEUM
A,H
4573
SPATHOLOBUS
SUBERECTUS
A,H
4574
SPEARMINT OIL
A,E,H
4575
SPEARMINT OIL
TERPENELESS

no more than 5%.
must be no more 1%.
4576
SPHINGOLIPIDS

186
Schedule 1

in the eye.
4577
SPIDER - EUROPEAN
GARDEN

4578
SPIGELIA
ANTHELMIA
A,H
4579
SPIGELIA
MARILANDICA
A,H

material.
4580
SPIKE LAVENDER
OIL
A,E,H

Spike lavender oil.
no more than 12.5%.
187
Schedule 1

label:
4581
SPINACH
4582
SPINACIA
OLERACEA
A,E,H
4583
SPIRODELA
POLYRRHIZA
A,H
4584
SPIRULINA

4585
SPONGE - MARINE

4586
SPRAY-DRIED
GLUCOSE SYRUP

flavour.
188
Schedule 1

no more than 5%.
4587
SPRUCE OIL

no more than 5%.
4588
SQUALANE
4589
SQUALENE
A,E
4590
SQUID OIL

dermal application.

label:
Must be obtained from species of the
order Teuthida of the class
Cephalopoda, be used in combination
with other ingredients in the medicine
and be presented in a therapeutic
dosage form for therapeutic use.
4591
SQUILL DRY
A,H
4592
SQUILL INDIAN DRY
A,H
4593
SQUILL INDIAN
POWDER
A,H
4594
SQUILL POWDER
A,H
4595
ST JOHN'S WORT
DRY EXTRACT
QUANTIFIED

label:
189
Schedule 1

4596
ST JOHN'S WORT
HERB DRY
A,H

label:
4597
ST JOHN'S WORT
HERB POWDER
A,H

label:
4598
STACHYS
OFFICINALIS
A,E,H
4599
STACHYS
PALUSTRIS
A,H
4600
STACHYURUS
HIMALAICUS
A,H
4601
STANNIC OXIDE

in the eye.
4602
STANNOUS
CHLORIDE

4603
STAR ANISE OIL
A,E

equal to or less than 50mL, a restricted
190
Schedule 1

the medicine label:
4604
STARCH

no more than 5%.
4605
STARCH - ACID
TREATED WAXY
MAIZE
4606
STARCH - GLUTENFREE WHEAT
4607
STARCH HYDROLYSED
MAIZE
4608
STARCH - MAIZE
A,E,H
4609
STARCH - MAIZE
HIGH AMYLOSE
A,E,H
4610
STARCH - MODIFIED
FOOD

flavour.
no more than 5%.
4611
STARCH - OXIDISED
MAIZE

flavour.
no more than 5%.
191
Schedule 1
4612
STARCH - OXIDISED
TAPIOCA
4613
STARCH - POTATO
4614
STARCH PREGELATINISED
MAIZE
4615
POTATO
4616
RICE
4617
WHEAT

other than topical or mucosal, gluten is
a mandatory component of Starch pregelatinised wheat.
label:
4618
STARCH - RICE
4619
STARCH - SOLUBLE
MAIZE
4620
STARCH - SOLUBLE
POTATO
4621
STARCH - TAPIOCA
4622
STARCH - WHEAT

other than topical or mucosal, gluten is
a mandatory component of Starch Wheat.
192
Schedule 1

label:
4623
STARCH SODIUM
OCTENYL
SUCCINATE
4624
STEARALKONIUM
CHLORIDE

dermal application.
4625
STEARALKONIUM
HECTORITE

dermal application.
4626
STEARAMIDE

dermal application.
4627
STEARAMIDOETHYL
DIETHYLAMINE

dermal application.
4628
STEARAMIDOPROPY
L DIMETHYLAMINE

dermal application.
4629
STEARAMIDOPROPY
L PG-DIMONIUM
CHLORIDE
PHOSPHATE

dermal application.
When the medicine is intended to be
used on the eye, the medicine requires
the medicine label:
4630
STEARETH-10

dermal application.
4631
STEARETH-100

193
Schedule 1
in the eye.
4632
STEARETH-2

dermal application.
4633
STEARETH-20

dermal application.
4634
STEARETH-21

dermal application.
4635
STEARETH-5

dermal application.
4636
STEARIC ACID
4637
STEAROPTENES

fragrance.
4638
STEAROXY
DIMETHICONE

in the eye.
4639
STEAROXYTRIMETH
YLSILANE

dermal application.
4640
STEAROYL
MACROGOLGLYCER
IDES
4641
STEARYL ACETATE
4642
STEARYL ALCOHOL

dermal application.
194
Schedule 1
4643
STEARYL
DIMETHICONE

in the eye.
label:
4644
STEARYL
GLYCYRRHETINATE

dermal application.
4645
STEARYL
HEPTANOATE

dermal application.
4646
STEARYL
MYRISTATE

fragrance.
4647
STEARYL STEARATE E
4648
STELLARIA
CHAMAEJASME
A,H
4649
STELLARIA
DICHOTOMA
A,H
4650
STELLARIA MEDIA
A,E,H
4651
STEMONA
JAPONICA
A,H
4652
STEMONA
A,H

dermal application.
195
Schedule 1
SESSILIFOLIA
4653
STENOTAPHRUM
SECUNDATUM
A,H
4654
STEPHANIA
TETRANDA
A,H
4655
STERCULIA
A,H
4656
STERCULIA
TRAGACANTHA
A,H
4657
STERCULIA URENS
A,H
4658
STEVIA
REBAUDIANA
A,E,H
4659
STEVIOL
GLYCOSIDES
4660
STILLINGIA
SYLVATICA
A,H
4661
STORAX PREPARED
A,E,H
4662
STRAWBERRY
4663
STRAWBERRY
ESSENCE

no more than 5%.
4664
STREPTOCOCCUS
THERMOPHILUS
4665
STRONG AMMONIA
SOLUTION
Ammonia is a mandatory component

of dilute ammonia solution.
The concentration of ammonia in the
When for internal use, the
no more than 0.25%.
196
Schedule 1
4666
STRONTIUM
CARBONATE

4667
STROPHANTHUS
GRATUS

4668
STROPHANTHUS
HISPIDUS

4669
STRYCHNOS
IGNATII

mandatory component of Strychnos
ignatii.
The concentration of Strychnine (of
Strychnos spp.) must be no more than
1 milligram/Kg or 1 milligram/L or
0.1%.
4670
STRYCHNOS NUXVOMICA
A,H

mandatory component of Strychnos
nux-vomica.
The concentration of Strychnine (of
Strychnos spp.) must be no more than
1 milligram/Kg or 1 milligram/L or
0.1%.
4671
STYPHNOLOBIUM
JAPONICUM
A,E,H
4672
STYRAX BENZOIN
A,E,H
4673
STYRAX OIL

no more than 5%.
197
Schedule 1
must be no more 1%.

4674
STYRAX
PARALLELONEURU
M
A,H
4675
STYRAX
TONKINENSIS
A,H
4676
STYRENE

fragrance.
4677
STYRENE/ACRYLAT
ES COPOLYMER

dermal application.
4678
STYROLYL
ACETATE

fragrance.
4679
SUCCINIC ACID
4680
SUCRALOSE
4681
SUCROSE
E,H

label:
198
Schedule 1

more sugars.
label:
to that effect).
4682
SUCROSE ACETATE
ISOBUTYRATE

no more than 5%.
4683
SUCROSE COCOATE

in the eye.
4684
SUCROSE
DISTEARATE

dermal application.
4685
SUCROSE LAURATE

Sucrose laurate.
label:
199
Schedule 1

more sugars.
label:
to that effect).
4686
SUCROSE
OCTAACETATE

sucrose is a mandatory component of
sucrose octaacetate.
label:
more sugars.
label:
to that effect).
4687
SUCROSE
PALMITATE

dermal application.
200
Schedule 1
4688
SUCROSE
POLYCOTTONSEED
ATE

in the eye.
label:
- (EYE) 'Avoid contact with the eyes'
4689
SUCROSE STEARATE E
For use in topical medicines for

in the eye.
no more than 0.25%.
For oral use as a manufacturing aid
only.
When for oral use, the concentration in
the medicine must be no more than 0.2
mg per dosage unit.
4690
SUDAN III

topical use.
4691
SUGAR CANE WAX

ALCOHOLS
A,H

dose must not provide more than
12mg.
label:
201
Schedule 1

4692
SUGARCANE
E,H

Sugarcane.
label:
more sugars.
label:
to that effect).
4693
SULFATED LOW
MOLECULAR
WEIGHT FUCANS

in the eye.
4694
SULFUR - SUBLIMED

4695
SULFUR DIOXIDE

202
Schedule 1

4696
SULFUR IODIDE

4697
SULFURIC ACID

4698
4699
SULFURISED 1METHYL-4-(1METHYLETHENYL)CYCLOHEXENE
SULISOBENZONE

fragrance.
sunscreens.
in the eye.
4700
SULISOBENZONE
SODIUM

sunscreens.
dermal application.
4701
SUNFLOWER OIL
A,E,H
4702
SUNFLOWER SEED
E,H
203
Schedule 1
4703
SUNSET YELLOW
FCF

and topical use.
4704
SUNSET YELLOW
FCF ALUMINIUM
LAKE

and topical use.
4705
SUPEROXIDE
DISMUTASE

dermal application.
4706
SWEDE
4707
SWEET ORANGE OIL

TERPENES AND
TERPENOIDS

no more than 5%.
must be no more 1%.
4708
SWEET POTATO
4709
SWERTIA CHIRATA
A,H
4710
SWIETENIA
MAHOGANI
A,H
4711
SYAGRUS
ROMANZOFFIANA
A,E,H
4712
SYMPHYTUM
OFFICINALE
When used orally as an active

homoeopathic ingredient, the
concentration must be a dilution of
12X or more.
When used in topical medicines for
dermal application, the concentration
in the preparation must be no more
than 10mg/kg or 10mg/L or 0.001%.
4713
SYMPLOCARPUS
FOETIDUS
A,H
204
Schedule 1
4714
SYRINGA
RETICULATA
A,H
4715
SYRINGA VULGARIS
A,H
4716
SYZYGIUM
AROMATICUM
A,E,H

the concentration of this oil in the
product is greater than 25%, the
When the plant preparation of is oil,
the concentration of this oil in the
medicine is greater than 25%, the
more than 15 mL but less than or equal
to 25 mL, a child resistant closure
When the plant preparation is oil, the
concentration of oil in the product is
greater than 25%, the nominal capacity
of the container is less than 15 mL, a
the container.
label:
4717
SYZYGIUM CUMINI
A,H
4718
TABEBUIA
SERRATIFOLIA
A,E,H
4719
TAGETES ERECTA
A,H
4720
TAGETES MINUTA
A,E,H
4721
TAGETES OIL

205
Schedule 1
no more than 5%.
must be no more 1%.
4722
TALC - PURIFIED
4723
TALLOW
4724
TALLOW
GLYCERIDES
4725
TAMARINDUS
INDICA

dermal application.

no more than 5%.
must be no more 1%.
4726
TAMARIX APHYLLA
A,H
4727
TAMARIX
CHINENSIS
A,H
4728
TAMARIX GALLICA
A,H
4729
TAMUS COMMUNIS
A,H
If the plant part is fruit or root, the

must be no more than 1mg of the
equivalent dry fruit or dry root of
Tamus communis.
4730
TANACETUM
CINERARIIFOLIUM
A,H

4731
TANACETUM
A,E,H
206
Schedule 1
PARTHENIUM
4732
TANACETUM
VULGARE
A,H
Oil (of Tanacetum vulgare) is a

mandatory component of Tanacetum
vulgare.
The concentration of oil (of
Tanacetum vulgare) in the medicine
4733
TANGERINE OIL

no more than 5%.
must be no more 1%.
4734
TANGERINE OIL
COLDPRESSED
A,E,H

Tangerine Oil Coldpressed, the
Oxedrine.
4735
TANNIC ACID
E,H

dermal application.
4736
TARAXACUM
MONGOLICUM
A,E,H
4737
TARAXACUM
OFFICINALE
A,E,H
4738
TARO
4739
TARRAGON OIL
A,E,H
4740
TARTARIC ACID
E,H

207
Schedule 1
4741
TARTRAZINE

and topical use.
label:
- (TART) 'Contains tartrazine' (or
4742
TARTRAZINE
ALUMINIUM LAKE

and topical use.
label:
- (TART) 'Contains tartrazine' (or
4743
TASMANNIA
LANCEOLATA

flavour.
no more than 5%.
4744
TAURINE
A,E
4745
TEA-STEARATE

dermal application.
4746
TERMINALIA
ARJUNA

bark.
dose must be no more than 6 grams of
Terminalia arjuna dried bark or its
extract equivalents.
label:
208
Schedule 1

- (CHILD2) 'Not suitable for children'.
4747
TERMINALIA
BELLIRICA
Only for use when the preparation is

as an aqueous extract of the fruit
pericarp.
4748
TERMINALIA
CATAPPA
A,H
4749
TERMINALIA
CHEBULA
A,H
4750
TERMINALIA
FERDINANDIANA
A,H

fruit flesh, fruit flesh dry or the
preparation is as an aqueous extract of
the fruit flesh.
4751
TERMINALIA
SERICEA

in the eye.
root bark.
Only methanol/water (90:10; V/V)
extract of Terminalia sericea bark of
the root is approved.
4752
TERPENE RESIN SYNTHETIC
Only for use in topical, oral or oral

application medicines.
oral, the dosage form must be chewing
gum.
4753
TERPINEN-4-OL

209
Schedule 1

no more than 5%.
must be no more 1%.
4754
TERPINEOL
A,E
Only for use in medicated space sprays

4755
TERPINEOL
ACETATE

no more than 5%.
must be no more 1%.
4756
TERPINOLENE

no more than 5%.
must be no more 1%.
4757
TERPINYL ACETATE

no more than 5%.
must be no more 1%.
4758
TERPINYL
210
Schedule 1
BUTYRATE

flavour.
no more than 5%.
4759
TERPINYL METHYL
ETHER

fragrance.
4760
TERT-BUTYL
ALCOHOL

dermal application.
4761
TERT-BUTYL
HYDROQUINONE

fragrance.
4762
TERT-BUTYL
METHYL ETHER

no more than 5%.
4763
TERTBUTYLPYRAZINE

fragrance.
4764
TETRACLINIS
ARTICULATA
A,E,H
4765
TETRADECYL
AMINOBUTYROYLV

211
Schedule 1
ALYLAMINOBUTYRI
C UREA
TRIFLUOROACETAT
E
4766
TETRADIUM
RUTICARPUM

A,H
When for internal use, oxedrine is a

mandatory component of Tetradium
ruticarpum.
The quantity of oxedrine in the
must be no more than 30 mg.
4767
TETRAHEXYLDECY
L ASCORBATE

in the eye.
4768
TETRAHYDRO-6-(3PENTENYL)-2HPYRAN-2-ONE

fragrance.
4769
TETRAHYDRO
LINALYLACETATE

fragrance.
4770
TETRAHYDRO
PARAMETHYLQUINOLINE

fragrance.
212
Schedule 1
4771
TETRAHYDRODIFER
ULOYLMETHANE

in the eye.
4772
TETRAHYDROFURF
URYL ACETATE

no more than 5%.
must be no more 1%.
4773
TETRAHYDROGERA
NYL ACETATE

fragrance.
4774
TETRAHYDROLINAL
OOL

fragrance.
4775
TETRAHYDROMUGU
OL

fragrance.
4776
TETRAHYDROMYRC
ENOL

213
Schedule 1
fragrance.
4777
TETRAHYDROXYPR
OPYL
ETHYLENEDIAMINE

dermal application.
4778
TETRAMETHYL
ACETYLOCTAHYDR
ONAPHTHALENES

no more than 5%.
must be no more 1%.
4779
TETRAPANAX
PAPYRIFER
A,H
4780
TETRASODIUM
ETIDRONATE

dermal application.
4781
TETRASODIUM
PYROPHOSPHATE

4782
TEUCRIUM
CHAMAEDRYS
A,H

Teucrium chamaedrys.
4783
TEUCRIUM MARUM
A,H

214
Schedule 1

Teucrium marum.
4784
TEUCRIUM
SCORODONIA
A,H

Teucrium scorodonia.
4785
THAPSIA
GARGANICA
A,H
4786
THAUMATIN
4787
THEASPIRANE

no more than 5%.
4788
THEMEDA
TRIANDRA
A,H
4789
THEOBROMA
CACAO
A,E,H

Theobroma cacao.
label:
of caffeine.
215
Schedule 1

medicine label:
4790
THEOBROMA OIL
A,E,H
4791
THEOBROMA
PREPARED
A,E,H

Theobroma Prepared.
label:
of caffeine.
medicine label:
4792
THIAMINE
A,E

medicine label:
216
Schedule 1

balanced diet.
4793
THIAMINE
HYDROCHLORIDE
A,E

medicine label:
balanced diet.
4794
THIAMINE NITRATE
A,E

medicine label:
balanced diet.
4795
THIOCINEOLE

fragrance.
4796
THIOTAURINE

in the eye.
217
Schedule 1
4797
THLASPI ARVENSE
A,E,H
4798
THREONINE
A,E
4799
THUJA
OCCIDENTALIS
A,H
4800
THUJA PLICATA
A,E,H
4801
THYME HERB DRY
A,E,H
4802
THYME OIL
A,E,H
When the concentration of Thyme oil

in the medicine is more than 50%, the
be no more than 25 mL, a restricted
the warning statement:
4803
THYMOL
A,E

product code must be medicated space
spray and medicated throat lozenges.
applications.
When used topically the medicine
- (THYMOL) 'Contains thymol
4804
THYMUS
CAPITATUS
A,E,H
When the plant preparation is an oil,

and the concentration in the medicine
more that 25 mL, a restricted flow
insert must be fitted on the container
and the medicine requires the
medicine label:- (CHILD) 'Keep out of
reach of children' (or words to that
218
Schedule 1
effect).
4805
THYMUS GLAND

4806
THYMUS
MASTICHINA
A,E,H

more that 25 mL, a restricted flow
effect).
4807
THYMUS
SERPYLLUM
A,E,H

effect).
4808
THYMUS VULGARIS
A,E,H

medicine label:
4809
THYMUS VULGARIS
MIS
A,E,H

219
Schedule 1

medicine label:
4810
THYMUS ZYGIS
A,H

medicine label:
4811
TILACTASE
Must be derived from Aspergillus

oryzae and comply with the relevant
USP monograph.
When the dosage form is undivided,
the units 'haemoglobin unit on the
tyrosine basis per gram' and 'Thousand
basis per gram' are permitted.
When the dosage form is divided, the
units 'haemoglobin units on the
tyrosine basis' and 'thousand
basis' are permitted.
4812
TILIA CORDATA
A,E,H
4813
TILIA
PLATYPHYLLOS
A,E,H
4814
TILIA TOMENTOSA
A,H
220
Schedule 1
4815
TILIA X VULGARIS
A,E,H
4816
TILIANTOL

fragrance.
4817
TIN
4818
TINOSPORA
SINENSIS
A,H
4819
TITANIUM DIOXIDE
A,E


sunscreens.
Only for use in topical medicines as a
colour, for dermal application and not
to be included in medicines intended
for use in the eye.
4820
TOCOCYSTEAMIDE

in the eye.
4821
TOCOFERSOLAN
Only for oral and topical use.

When for oral use, the concentration in
10% w/w.
When used in topical medicines for
dermal application, it is not to be
in the eye.
221
Schedule 1

no more than 0.1%
4822
TOCOPHEROL

no more than 5%.
must be no more 1%.
4823
TOCOPHEROLS
CONCENTRATE MIXED (HIGHALPHA TYPE)
A,E

medicine label:
balanced diet.
4824
TOCOPHEROLS
CONCENTRATE MIXED (LOW-ALPHA
TYPE)
A,E

medicine label:
balanced diet.
4825
TOCOPHERYL
LINOLEATE

dermal application.
4826
TOCOPHERYL
NICOTINATE

in the eye.
222
Schedule 1
The concentration must not exceed

0.3%.
4827
TOLU BALSAM
A,E,H
4828
TOLUENE
The residual solvent limit for toluene

is 8.9 mg per maximum recommended
daily dose.
4829
TOLYL ALDEHYDE

no more than 5%.
must be no more 1%.
4830
TOLYLALDEHYDE
GLYCERYLACETAL

no more than 5%.
4831
TOMATO
E,H

4832
TONKA

fragrance.
4833
TONKA BEAN
EXTRACT

223
Schedule 1

no more than 5%.
must be no more 1%.
4834
TONONE

fragrance.
4835
TOXICODENDRON
DIVERSILOBUM

4836
TOXICODENDRON
PUBESCENS

Toxicodendron pubescens.
4837
TOXICODENDRON
RADICANS
A,H

Toxicodendron radicans.
4838
TOXICODENDRON
SUCCEDANEUM

4839
TRACHELOSPERMU
M JASMINOIDES
A,E,H
4840
TRACHYSPERMUM
AMMI
Only for use in oral medicines when

the plant part is fruit or seed.
label:
224
Schedule 1

or likely to become pregnant' (or
4841
TRAGACANTH
A,E
4842
TRAMETES
VERSICOLOR
A,H
Trametes versicolor hyphae dry extract

must only be prepared using water.
4843
TRAMETES
VERSICOLOR
PROTEOGLYCAN
CONCENTRATE
A,H
4844
TRANS-1-(2,4,4TRIMETHYL-2CYCLOHEXEN-1YL)-2-BUTEN-1-ONE

fragrance.
TRANS-2-DECENAL
4845

flavour.
no more than 5%.
4846
TRANS-2DODECENAL

no more than 5%.
must be no more 1%.
4847
TRANS-2-HEPTEN-1AL

225
Schedule 1
no more than 5%.
4848
TRANS-2-HEXENAL

no more than 5%.
must be no more 1%.
4849
TRANS-2-HEXENOIC
ACID

no more than 5%.
4850
TRANS-2-HEXENOL

no more than 5%.
must be no more 1%.
4851
TRANS-2-HEXENYL
ACETATE

no more than 5%.
4852
TRANS-2-HEXENYL
226
Schedule 1
PHENYLACETATE

flavour.
no more than 5%.
4853
TRANS-2HYDROXYCINNAMI
C ACID

flavour.
no more than 5%.
4854
TRANS-2UNDECENAL

no more than 5%.
4855
TRANS-3-HEXENOIC
ACID

no more than 5%.
4856
TRANS-4-DECENAL

fragrance.
4857
TRANS-8-(1METHYLETHYL)-1OXASPIRO(4.5)DECA
N-2-ONE

fragrance.
227
Schedule 1
4858
TRANS-ETHYL 2OCTENOATE

no more than 5%.
4859
TRANS-METHYL-2HEXENOATE

flavour.
no more than 5%.
4860
TRANS,TRANS-2,4DECADIEN-1-AL

flavour.
no more than 5%.
4861
TRANS,TRANS-2,4HEXADIENAL

flavour.
no more than 5%.
4862
TREACLE

Treacle.
label:
228
Schedule 1

more sugars.
label:
to that effect).
4863
TREFRIW WELLS
MINERAL WATER

mandatory component of Trefriw
Wells mineral water.
Solid dosage forms containing more
than 5 milligrams of elemental iron in
each dosage unit are required to have a
Liquid Preparations containing more
than 250 milligrams of elemental iron
in the total contents of the container
are required to have a child resistant
closure.
Only able to be used when presented
in single use sachets for therapeutic
use as an iron supplement.
4864
TREHALOSE
DIHYDRATE
4865
TREMELLA
FUCIFORMIS
A,H
4866
TRIACETIN

dermal application.
229
Schedule 1
4867
TRIACONTANYL
PVP
4868
TRIADICA SEBIFERA
A,H
4869
TRIBEHENIN

dermal application.

in the eye.
4870
TRIBEHENIN PEG-20
ESTERS

in the eye.
4871
TRIBULUS
TERRESTRIS
A,E,H
4872
TRIBUTYL
ACETYLCITRATE

fragrance.
4873
TRICALCIUM
PHOSPHATE
4874
TRICAPRYLIN

in the eye.
4875
TRICAPRYLYL
CITRATE

230
Schedule 1
in the eye.
4876
TRICETEARETH-4
PHOSPHATE

dermal application.
4877
TRICHLOROMETHY
LPHENYLCARBINYL
ACETATE

fragrance.
4878
TRICHODERMA
VIRIDE
A,E,H
4879
TRICHOSANTHES
KIRILOWII
A,E,H
4880
TRICLOSAN

label:
- (TRICLO) 'Contains triclosan
4881
TRICYCLODECENYL
PROPIONATE

fragrance.
4882
TRIDECANAL

fragrance.
231
Schedule 1
4883
TRIDECETH-4
PHOSPHATE

dermal application.
4884
TRIDECETH-6

4885
TRIDECYL
ALCOHOL

fragrance.
4886
TRIDECYL
BEHENATE

component of Tridecyl behenate.
dermal application.
4887
TRIDECYL
NEOPENTANOATE

in the eye.
4888
TRIDECYL
SALICYLATE

in the eye.
4889
TRIDECYL
STEARATE

dermal application.
4890
TRIDECYL
TRIMELLITATE

dermal application.
232
Schedule 1
4891
TRIETHOXYCAPRYL
YLSILANE

4892
TRIETHYL CITRATE
4893
TRIETHYLENE
GLYCOL
4894
TRIFOLIUM
PRATENSE
A,E,H
4895
TRIFOLIUM REPENS
A,H
4896
TRIGONELLA
FOENUM-GRAECUM
A,E,H
4897
TRIHYDROXYPALMI
TAMIDOHYDROXYP
ROPYL MYRISTYL
ETHER

in the eye.
4898
TRIHYDROXYSTEAR
IN

dermal application.
4899
TRIISOCETYL
CITRATE

dermal application.
4900
TRIISODECYL
TRIMELLITATE

in the eye.
4901
TRIISONONANOIN

in the eye.
233
Schedule 1

4902
TRIISOSTEARIN

dermal application.
4903
TRILAURIN

dermal application.
4904
TRILISA
ODORATISSIMA
A,H
4905
TRILLIUM ERECTUM
A,H
4906
TRIMETHOXYCAPR
YLYL SILANE

in the eye.
4907
4908
TRIMETHYLBICYCLO-HEPTANESPIROCYCLOHEXEN
ONE
TRIMETHYL
HYDROXYPENTYL
ISOBUTYRATE

fragrance.
fragrance.
4909
TRIMETHYL
UNDECYLENIC
ALDEHYDE

fragrance.
4910
TRIMETHYLBENZEN
234
Schedule 1
EPROPANOL

fragrance.
4911
TRIMETHYLHEXAN
OL

fragrance.
4912
TRIMETHYLOPROPA
NE TRIOCTANOATE

dermal application.
4913
TRIMETHYLPENTAN
EDIOL/ADIPIC
ACID/GLYCERIN
CROSSPOLYMER

in the eye.
4914
TRIMETHYLSILOXY
SILICATE

dermal application.
4915
TRINITROPHENOL

4916
TRIOCTANOIN

in the eye.
4917
TRIOCTYLDODECYL
CITRATE

in the eye.
235
Schedule 1

4918
TRIOLEIN

in the eye.
4919
TRIOSTEUM
PERFOLIATUM
A,H
4920
TRIOXAUNDECANE
DIOIC ACID
4921
TRIPAL

fragrance.
4922
TRIPEPTIDE-1

4923
TRIS-BIPHENYL
TRIAZINE

When used topically, the dosage form
must not be spray.
4924
TRISILOXANE

236
Schedule 1
in the eye.
4925
TRISODIUM
EDETATE

dermal application.
4926
TRISODIUM
ETHYLENEDIAMINE
DISUCCINATE

in the eye.
4927
TRISODIUM NTA

in the eye.
4928
TRISTEARIN
4929
TRITICUM
AESTIVUM
A,E,H

when the plant part is seed and the
label:
4930
TRITICUM DURUM
A,E,H

when the plant part is seed and the
237
Schedule 1

label:
4931
TRIUNDECANOIN

in the eye.
4932
TROLAMINE

dermal application.
4933
TROLAMINE LAURIL
SULFATE

dermal application.
4934
TROLAMINE
SALICYLATE

sunscreens.
dermal application.
4935
TROLLIUS
CHINENSIS
A,H
4936
TROMETAMOL
4937
TROMETAMOL
HYDROCHLORIDE
4938
TROPAEOLUM
MAJUS
A,E,H
4939
TROPICAL
RATTLESNAKE

238
Schedule 1
4940
TROPOLONE

in the eye.
4941
TSUGA
CANADENSIS
A,H
4942
TULIPA EDULIS
A,H
Colchicine is a mandatory component

of Tulipa edulis.
The concentration of colchicine in the
4943
TURMERIC
4944
TURNERA DIFFUSA
A,E,H
4945
TURNIP
4946
TURPENTINE OIL
A,E
4947
TYPHA
ANGUSTIFOLIA
A,H
4948
TYPHA LATIFOLIA
A,H
4949
TYPHONIUM
GIGANTEUM
A,H
4950
TYROSINE
A,E

colour.

239
Schedule 1
Column 1
4951
Column 2
Column 3
Column 4
Ingredient Name
Purpose
of the
ingredient
in the
medicine

UBIDECARENONE
A,E
When used as an excipient, the route

of administration must be topical.
in the eye.
When used as an excipient, the
no more than 0.05%.
dose must provide no more than 150
mg of ubidecarenone.
When used in combination with
Ubiquinol-10, the maximum
no more than 300 mg of ubiquinol-10
and ubidecarenone combined.
label:
- (WARF) 'Do not take while on
advice.'
4952
UBIQUINOL-10

dose must provide no more than 300
mg of ubiquinol-10.
When used in combination with
ubidecarenone, the maximum
Schedule 1
no more than 300 mg of ubiquinol-10

and ubidecarenone combined.
- (WARF) 'Do not take while on
advice.'
4953
ULEX EUROPAEUS
A,H
4954
ULMUS AMERICANA
A,H
4955
ULMUS
CAMPESTRIS
A,H
4956
ULMUS GLABRA
A,H
4957
ULMUS PARVIFOLIA
A,H
4958
ULMUS PROCERA
A,H
4959
ULMUS PUMILA
A,H
4960
ULMUS RUBRA
A,H
4961
ULTRALIDE

fragrance.
4962
ULTRAMARINE
BLUE

topical use.
4963
ULVA LACTUCA
A,H

Ulva lactuca.
in the eye.
Schedule 1

4964
UNCARIA GAMBIR
A,H
4965
UNCARIA
RHYNCOPHYLLA
A,H
4966
UNCARIA SINENSIS
A,H
4967
UNCARIA
TOMENTOSA
A,H
4968
UNDARIA
PINNATIFIDA
A,H
Whole dried Undaria pinnatifida must

not contain the holdfast.
4969
UNDECANAL

no more than 5%.
must be no more 1%.
4970
UNDECANOIC ACID

flavour.
Schedule 1

no more than 5%.
4971
UNDECENOIC ACID
4972
UNDECYL ALCOHOL

no more than 5%.
must be no more 1%.
4973
UNDECYLCRYLENE
DIMETICONE

in the eye.
4974
UNDECYLENAMIDE
DEA
4975
UNDECYLENOYL
PEG-5 PARABEN

dermal application.
4976
URANIUM NITRATE

4977
UREA
A,E,H

dermal application.
must be no more than 10% (w/w).
4978
URTICA DIOICA
A,E,H
4979
URTICA URENS
A,H
4980
USNEA BARBATA
A,H
4981
UVA URSI LEAF DRY
A,H
Schedule 1
4982
UVA URSI LEAF

POWDER
A,E,H
4983
VA/BUTYL
MALEATE/ISOBORN
YL ACRYLATE
COPOLYMER
Vinyl acetate is a mandatory

component of VA/butyl
maleate/isobornyl acrylate copolymer.
The concentration of vinyl acetate in
0.01% or 100 ppm.
in the eye.
4984
VACCARIA
SEGATALIS
A,H
4985
VACCINIUM
BRACTEATUM
A,H
4986
VACCINIUM
CORYMBOSUM

flavour.
no more than 5%.
4987
VACCINIUM
MACROCARPON
A,E,H
4988
VACCINIUM
MYRTILLOIDES
A,H
4989
VACCINIUM
MYRTILLUS
A,E,H
4990
VACCINIUM
OXYCOCCUS
A,H
4991
VACCINIUM VITISIDAEA
A,H
Schedule 1
4992
VALENCENE

flavour.
no more than 5%.
4993
VALERIAN DRY
A,H
4994
VALERIAN OIL

flavour.
no more than 5%.
4995
VALERIAN POWDER
A,H
4996
VALERIANA EDULIS
A,H
4997
VALERIANA
OFFICINALIS
A,H
4998
VALERIANA
SORBIFOLIA
A,H
4999
VALERIC ACID

flavour.
no more than 5%.
5000
VALINE
A,E
5001
VANADIUM
5002
VANILLA

no more than 5%.
Schedule 1

must be no more 1%.
5003
VANILLA DRY
A,E,H
5004
VANILLA EXTRACT

flavour.
no more than 5%.
5005
VANILLA
OLEORESIN

flavour.
no more than 5%.
5006
VANILLA
PLANIFOLIA
A,E,H
5007
VANILLA POWDER
A,E,H
5008
VANILLA
TAHITENSIS
A,H
5009
VANILLIC ACID

flavour.
no more than 5%.
5010
VANILLIN
Permitted for use as a flavour.
5011
VANILLIN
ISOBUTYRATE

no more than 5%.
Schedule 1

must be no more 1%.
5012
VANILLYL
ALCOHOL

flavour.
no more than 5%.
5013
VAT RED 1

topical use.
5014
VAT RED 1
ALUMINIUM LAKE

topical use.
5015
VAT RED 5

topical use.
5016
VEGETABLE OIL
5017
VEGETABLE OIL HYDROGENATED
5018
VEGETABLE OIL
PHYTOSTEROL
ESTERS

label:
- (VOPE) 'There is no benefit from
taking more than 3g/day of
phytosterols from all sources'
5019
VEGETABLE
PROTEIN HYDROLYSED
5020
VEIN

Schedule 1
5021
VERATRALDEHYDE

no more than 5%.
must be no more 1%.
5022
VERATRUM ALBUM
A,H
Solanidine is a mandatory component

of Veratrum album.
Veratrum album in the medicine must
or 0.001%.
5023
VERBASCUM
DENSIFLORUM
A,H
5024
VERBASCUM
THAPSUS
A,H
5025
VERBENA
OFFICINALIS
A,H
5026
VERBENA OIL

flavour.
no more than 5%.
5027
VERONICA
CHAMAEDRYS
A,H
5028
VERONICA
OFFICINALIS
A,H
5029
VERONICASTRUM
VIRGINICUM
A,E,H
5030
VETIVER OIL
Schedule 1

no more than 5%.
must be no more 1%.
5031
VETIVERYL
ACETATE

fragrance.
5032
VIBURNUM OPULUS
A,E,H
5033
VIBURNUM
PRUNIFOLIUM
A,E,H
5034
VICIA FABA
A,H
Levodopa (of Vicia faba) is a

mandatory component of Vicia faba.
Vicia faba) from all ingredients in the
1mg/kg or 1mg/L or 0.1%.
5035
VIGNA ANGULARIS
VAR. ANGULARIS
A,H
5036
VIGNA RADIATA
A,H
5037
VIGNA UMBELLATA
A,H
5038
VINCA MAJOR
A,H
Vincamine is a mandatory component

of Vinca major.
The concentration of vincamine in the
10mg/kg or 10 mg/L or 0.001%.
5039
VINCA MINOR
A,H
Vincamine and vincristine are

mandatory components of Vinca
10
Schedule 1
minor.
The concentration of vincamine in the
10mg/kg or 10 mg/L or 0.001%.
The concentration of Vincristine in the
10mg/kg or 10mg/L or 0.001%
5040
VINCETOXICUM
OFFICINALE
A,H
5041
VINEGAR

flavour.
no more than 5%.
5042
VIOLA ODORATA
A,E,H
5043
VIOLA TRICOLOR
A,H
5044
VIOLA YEDOENSIS
A,H
5045
VIOLET LEAF
ABSOLUTE

no more than 5%.
must be no more 1%.
5046
VIOLET LEAVES

flavour.
no more than 5%.
11
Schedule 1
5047
VIPER
5048
VISCUM ALBUM
A,E,H
5049
VISCUM
COLORATUM
A,H
5050
VISCUM
FLAVESCENS
A,H
5051
VITELLARIA
PARADOXA
A,E,H
5052
VITEX AGNUSCASTUS
A,E,H
5053
VITEX NEGUNDO
A,H
5054
VITEX
ROTUNDIFOLIA
A,H
5055
VITEX TRIFOLIA
A,H
5056
VITIS VINIFERA
A,E,H
5057
VITREOSCILLA
CONCENTRATE


dermal application.
5058
WAHLENBERGIA
GRACILIS
A,H
5059
WALNUT
5060
WALNUT OIL
5061
WATER - POTABLE
5062
WATER - PURIFIED
5063
WATER MELON
5064
WAX EMULSIFYING
12
Schedule 1
5065
WAX MICROCRYSTALLIN
E
Only for use as an excipient in

medicines for topical, oral or oral
application routes of administration.
When microcrystalline wax is used as
an excipient ingredient, the route of
administration 'oral' is only permitted
when the dosage form is 'chewing
gum'.
5066
WAX - SYNTHETIC
5067
WHEAT

Wheat when the route of
mucosal.
label:
5068
WHEAT BRAN

Wheat bran when the route of
mucosal.
label:
5069
WHEAT DEXTRIN
A,E

capsule, tablet or pill.
13
Schedule 1
label:
5070
WHEAT GERM

Wheat germ when the route of
mucosal.
label:
5071
WHEAT GERM
GLYCERIDES

Wheat germ glycerides when the route
of administration is other than topical
and mucosal.
label:
5072
WHEAT LEAF
5073
WHEAT PROTEIN HYDROLYSED

label:
5074
WHEAT SPROUT

Wheat sprout when the route of
14
Schedule 1
mucosal.
label:
5075
WHEATGERM OIL
A,E,H
5076
WHEY POWDER
Lactose is a mandatory component of

Whey powder when the route of
administration is oral.
5077
WHEY PROTEIN
Lactose is a mandatory component of

Whey protein when the route of
administration is oral.
5078
WHEY PROTEIN
CONCENTRATE

flavour.
no more than 5%.
5079
WHITE HOREHOUND
HERB DRY
A,H
5080
WHITE HOREHOUND
HERB POWDER
A,H
5081
WHITE SOFT
PARAFFIN
A,E
5082
WIKSTROEMIA
VIRIDIFLORA
A,H
5083
WILD CARROT HERB
A,E,H

15
Schedule 1
DRY
5084
WILD CARROT HERB

POWDER
A,H
5085
WILD CHERRY
BARK DRY
A,H
5086
WILD CHERRY
BARK POWDER
A,H
5087
WILD LETTUCE
LEAF DRY
A,H
5088
WILD LETTUCE
LEAF POWDER
A,H
5089
WINE - FORTIFIED

Wine - fortified.
label:
contains alcohol'
5090
WINTERGREEN OIL
A,E,H

component of Wintergreen oil.
The concentration of Methyl salicylate
0.001%.
16
Schedule 1

5091
WITHANIA
SOMNIFERA
A,E,H
5092
WOOL ALCOHOLS

dermal application.
5093
WOOL FAT
A,E

5094
WOOL FAT HYDROUS
A,E

5095
XANTHAN GUM
5096
XANTHIUM
SIBIRICUM
A,H
5097
XANTHIUM
STRUMARIUM
A,H
5098
XANTHOMONA
CAMPESTRIS
A,H
5099
XEROPHYLLUM
ASPHODELOIDES
A,H
5100
XYLENE
The residual solvent limit for xylene is

21.7 mg per maximum recommended
17
Schedule 1
daily dose.
5101
XYLITOL

medicine label:
5102
XYLOSE
5103
YAM
5104
YARROW HERB DRY
A,H
5105
YARROW HERB
POWDER
A,H
5106
YEAST - HIGH
CHROMIUM
A,E

of Yeast - high chromium.
The maximum daily dose of chromium
from Yeast - high chromium must be
no more than 50 micrograms as Yeast
- high chromium is considered to be an
organic form of chromium.
5107
YEAST - HIGH
MOLYBDENUM
A,E
component of Yeast - high
molybdenum.
molybdenum from yeast - high
18
Schedule 1
molybdenum must be no more than

62.5 micrograms.
5108
YEAST - HIGH
SELENIUM

selenium is a mandatory component of
Yeast - high selenium.
should not be exceeded'.
5109
YEAST
AUTOLYSATE
5110
YEAST DRIED
A,E,H
5111
YELLOW 2G

topical use.
5112
YELLOW MERCURIC
OXIDE

5113
YELLOW SOFT
PARAFFIN
A,E

dermal application.
19
Schedule 1

5114
YLANG YLANG OIL
A,E,H
5115
YUCCA BACCATA
A,H
5116
YUCCA ELATA
A,H
5117
YUCCA
FILAMENTOSA
A,H
5118
YUCCA GLORIOSA
A,H
5119
YUCCA WHIPPLEI
A,H
5120
ZANTHOXYLUM
AMERICANUM
A,H
5121
ZANTHOXYLUM
BUNGEANUM
A,E,H
5122
ZANTHOXYLUM
CLAVA-HERCULIS
A,H
5123
ZANTHOXYLUM
NITIDUM
A,H
5124
ZANTHOXYLUM
PIPERITUM
A,H
5125
ZANTHOXYLUM
SIMULANS
A,H
5126
ZEA MAYS
A,E,H
5127
ZEAXANTHIN
A,E
5128
ZEIN
5129
ZINC

ingredient.
20
Schedule 1

the medicine label:
for a long period (or words to that
effect)'.
5130
ZINC AMINO ACID

CHELATE
A,E,H
When used internally, zinc is a

mandatory component of zinc amino
acid chelate.
The concentration of zinc in zinc
amino acid chelate must be no more
than 30%.
5131
ZINC ASCORBATE
A,E,H

mandatory component of zinc
ascorbate.
The percentage of zinc from zinc
ascorbate should be calculated based
on the molecular weight of zinc
ascorbate.
21
Schedule 1
the medicine label:

effect)'.
5132
ZINC ASCORBATE
MONOHYDRATE
A,E,H

ascorbate monohydrate.
The percentage of zinc from Zinc
ascorbate monohydrate should be
weight of Zinc ascorbate
monohydrate.
the medicine label:
effect)'.
22
Schedule 1

5133
ZINC CHLORIDE
A,E,H
The concentration of zinc chloride in

5%.
chloride. The percentage of zinc from
zinc chloride should be calculated
based on the molecular weight of zinc
chloride.
the medicine label:
effect)'.
5134
ZINC CITRATE
A,E,H

mandatory component of zinc citrate .
citrate should be calculated based on
the molecular weight of zinc citrate .
23
Schedule 1

the medicine label:
effect)'.
5135
ZINC CITRATE
DIHYDRATE
A,E,H

mandatory component of zinc citrate
dihydrate.
citrate dihydrate should be calculated
based on the molecular weight of zinc
citrate dihydrate.
the medicine label:
24
Schedule 1

effect)'.
5136
ZINC CITRATE
TRIHYDRATE
A,E,H

mandatory component of zinc citrate
trihydrate. The percentage of zinc
from Zinc citrate trihydrate should be
weight of Zinc citrate trihydrate.
the medicine label:
effect)'.
5137
ZINC DIASPARTATE

diaspartate and availability is restricted
mineral only.
25
Schedule 1

diaspartate should be calculated based
on the molecular weight of Zinc
diaspartate.
the medicine label:
effect)'.
5138
ZINC GLUCONATE
A,E,H

gluconate.
gluconate.
26
Schedule 1

the medicine label:
effect)'.
5139
ZINC GLYCINATE

mandatory component of Zinc
glycinate and availability is restricted
mineral only.
glycinate.
the medicine label:
effect)'.
27
Schedule 1

5140
ZINC LACTATE
Only for use in topical and dental

medicines and not to be included in
The concentration of zinc lactate in a
medicine intended for topical use
should be no more than 2%.
The concentration of Zinc lactate in a
medicine for 'dental' use in toothpaste
medicines must be no more than 2.5%.
Zinc lactate is not to be included in
dental / toothpaste medicines intended
for use by children less than 12 years
old.
Medicines containing Zinc lactate for
dental use require the following
label:
years is not recommended'.
5141
ZINC LACTATE
DIHYDRATE
Only for use in topical and dental

medicines and not to be included in
The concentration of Zinc lactate
dihydrate in a medicine intended for
topical use should be no more than
2%.
The concentration of Zinc lactate
dihydrate in a medicine for 'dental' use
in toothpaste medicines must be no
more than 2.5%.
Zinc lactate dihydrate is not to be
included in dental / toothpaste
medicines intended for use by children
28
Schedule 1
less than 12 years old.

Medicines containing Zinc lactate for
dental use require the following
label:
years is not recommended'.
5142
ZINC LYSINATE

mandatory component of Zinc lysinate
and availability is restricted to use as a
lysinate should be calculated based on
the molecular weight of Zinc lysinate.
the medicine label:
effect)'.
5143
ZINC METHIONINE
SULFATE
For topical use, the concentration of

zinc sulfate must be no more than 5%.
29
Schedule 1
mandatory component of Zinc

methionine sulfate and availability is
methionine sulfate should be
weight of Zinc methionine sulfate.
the medicine label:
effect)'.
5144
ZINC MYRISTATE

in the eye.
5145
ZINC OXIDE
A,E,H

mandatory component of zinc oxide.
The percentage of Zinc from zinc
30
Schedule 1
oxide should be calculated based on

the molecular weight of zinc oxide.
5146
ZINC PARAPHENOLSULFONATE
The concentration of zinc paraphenolsulfonate in the medicine must

not exceed 5%.
mandatory component of zinc paraphenolsulfate.
accepted percentage of zinc from zinc
para-phenolsulfate is 15.9%. The
declared quantity of zinc from zinc
para-phenolsulfate must be no less
16.7% of the zinc para-phenolsulfate
5147
ZINC STEARATE

mandatory component of zinc stearate.
stearate is between 10% and 12%.
The declared quantity of zinc from
zinc stearate must be no less than 9.5%
and mustbe no more than 12.6% of the
zinc stearate in the formulation. These
5148
ZINC SUCCINATE
A,E,H

succinate.
succinate should be calculated based
31
Schedule 1

succinate.
the medicine label:
effect)'.
5149
ZINC SULFATE
A,E

For internal use, zinc is a mandatory
component of zinc sulfate.
sulfate should be calculated based on
the molecular weight of Zinc sulfate.
32
Schedule 1
the medicine label:

effect)'.
5150
ZINC SULFATE
HEPTAHYDRATE
A,E

component of zinc sulfate
heptahydrate.
weight of Zinc sulfate heptahydrate.
the medicine label:
effect)'.
33
Schedule 1

5151
ZINC SULFATE
HEXAHYDRATE
A,E,H

component of zinc sulfate
hexahydrate.
weight of Zinc sulfate hexahydrate.
the medicine label:
effect)'.
5152
ZINC SULFATE
MONOHYDRATE
A,E,H

topical the concentration of zinc
sulfate in the medicine must be no
more than 5%.
34
Schedule 1
When the medicine is for internal use,

zinc is a mandatory component of zinc
the medicine label:
effect)'.
5153
ZINC VALERATE

ingredient.
component of zinc valerate.
valerate is 24.5%. The declared
quantity of zinc from zinc valerate
must be no less than 23.2% and must
be no more than 25.7% of the zinc
valerate in the formulation. These
5154
ZINGERONE

35
Schedule 1
flavour.
no more than 5%.
5155
ZINGIBER
OFFICINALE
A,E,H
When for oral use AND the extract

ratio is equal to or more than 25:1 OR
the equivalent dry weight per dosage
unit is equal to OR more than 2g, the
label:
- (GINGER) 'Individuals taking
anticoagulants should seek medical
advice before taking this medicine.'
AND 'Individuals at risk of bleeding
problems should seek advice from
their healthcare practitioner prior to
taking this medicine'
5156
ZIZIPHUS JUJUBA
A,H
5157
ZIZIPHUS JUJUBA
VAR. SPINOSA
A,H
5158
ZIZYPHUS SATIVA
A,H
5159
ZOSTERA MARINA
A,H
5160
ZUCCHINI
36
EXPLANATORY STATEMENT
Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2016
Subsection 26BB(1), Therapeutic Goods Act 1989
The Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2016

(the Determination) is a determination made by the Minister under subsection 26BB(1) of the
Therapeutic Goods Act 1989 (the Act) and has the effect of specifying ingredients that may
be contained in a medicine listed in the Australian Register of Therapeutic Goods
(the Register) under section 26A of the Act, and requirements in relation to the inclusion of
those ingredients in such medicines.
The Determination is also intended to succeed (i.e. revoke and replace) the previous
Determination which specified ingredients and related requirements for such medicines - the
Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2016, which
commenced on 29 April 2016 (the previous Determination).
The Determination will commence on the day after it is registered on the Federal Register of
Legislation.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls for
the quality, safety, efficacy and timely availability of therapeutic goods that are used in or
exported from Australia. The Therapeutic Goods Administration (the TGA), which is part of
the Department of Health, is responsible for administering the Act.
One of the controls established by the Act is to require that medicines that are listed in the
Register under section 26A of the Act (listed medicines) only include ingredients which have
been evaluated for safety and quality, and that consideration has been given to whether any
conditions should be attached to the use of the ingredient, so that safety and quality can be
maintained. The Determination supports the achievement of this control, by providing for a
list of ingredients which have been assessed or determined previously to be safe and
providing for the requirements applying to particular ingredients when contained in a relevant
medicine.
Prior to the making of the first determination under subsection 26BB(1) of the Act, the
Therapeutic Goods (Permissible Ingredients) Determination No.1 of 2015 (the original
Determination), ingredients were authorised for use in listed medicines generally through the
list of ingredients in Schedule 4 to the Therapeutic Goods Regulations 1990, or through
notices made by the Minister under subsection 9A(5) of the Act (Listing Notices).
Authorised Version Explanatory Statement registered 01/08/2016 to F2016L01253
The Determination, however, provides for a single, comprehensive list of ingredients

permitted for use in listed medicines, along with requirements applying to the use of
particular ingredients included in listed medicines.
The requirements imposed under the Determination principally relate to ensuring the quality
and safety of the ingredient when used. Requirements may relate, for example, to:
how the ingredient is to be used in the medicine, for example as a standard active,
homoeopathic, or excipient ingredient;
the method of ingestion or application, for example oral or topical use;
the source of the ingredient, or the method of manufacture;
appropriate limits on volume or concentration of the ingredient contained in the
medicine; and
the inclusion of relevant safety information on product labels, for example allergen
advice, or advice about the use of the ingredient for susceptible members of the
population such as small children and pregnant women.
The purpose of the Determination is to revoke and replace the previous Determination with
this Determination that includes new ingredients that will be available for use in listed
medicines, and that also incorporates a number of other changes to the previous
Determination. The Determination will also remove availability of one ingredient from use in
listed medicines.
These changes include:
adding 38 ingredients for use in listed medicines, along with associated requirements
relating to their use in these products for example, Magnesium chloride 4.5-hydrate is
included and permitted for use with standard active, excipient and homeopathic purposes,
and Leaf acetal has been included and permitted for use if in combination with other
permitted ingredients as a flavour and subject to a total flavour concentration limitation;
making changes to the requirements relating to the use of some ingredients approved for
use in listed medicines, principally in order to: clarify a number of existing requirements
(without changing their effect) to make them clearer, and to update some ingredient
specific requirements in line with recent changes to requirements for these substances
included in the Poisons Standard (Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP));
removing references to some of the purposes for which a number of existing ingredients
may be used in listed medicines, or to add new such purposes. This includes correcting
unintended errors in the previous Determination for active purposes (A) inadvertently
included for some ingredients. Removing these purposes brings the Determination into
line with the requirements that applied to such ingredients before the making of the
previous Determination. The Determination also removes the active and excipient
purposes for the ingredient Sanguinaria canadensis. The effect of this change is that
Sanguinaria canadensis is suitable for homoeopathic use more dilute than 4X only, on the
basis of a recent ingredient safety evaluation;
updating a number of ingredient names (by removing ingredient name synonyms), as part
of moving to internationally accepted terminology for ingredient naming this is designed
to, among other things, assist health professionals and the public to compare similar
therapeutic goods and to avoid confusion between goods; and
removing availability for the ingredient Musk Ambrette from use in listed complementary
medicines, to update the Determination in line with a recent medicines scheduling decision
to include the substance in Schedule 10 of the Poisons Standard.
The Determination includes newly evaluated ingredients in the subsection 26BB(1)
Determination for the first time. For example, Euterpe oleracea, is included for active use
with the restriction that the ingredient must be derived from the fruit only. Additionally, the
Determination includes standard active use for the ingredient Lauric acid, which has recently
been evaluated for use in listed complementary medicines as an active ingredient in oral
medicines only and where the maximum recommended daily dose must not exceed 1500 mg.
It is expected that updated Determinations will be made on a quarterly basis - the need to
make timely updates to the Determination available arises for a number of reasons, including
to ensure that new ingredients requested by industry are made available for use in listed
medicines as soon as possible after they have been assessed or determined to be safe. In
addition, as listed medicines are not prescribed by a doctor and are freely available, there is
an imperative to ensure that the Determination is accurate, and is routinely maintained, so as
to provide clear requirements for industry about what ingredients can be safely used in listed
medicines and, about what safety information needs to be provided to consumers on product
labels to ensure the safe use of those products by the public.
CONSULTATION
Consultation was undertaken with industry in early 2016 in the lead up to making the
previous Determination. The majority of changes in the previous Determination were made to
correct inadvertent errors and to bring ingredient requirements into line with those that
existed before the making of the original Determination on 1 January 2016.
Consultation has continued since early 2016 on the range of changes proposed to be made to
the previous Determination, through face-to-face briefings, teleconferences and written
correspondence. Key industry associations were provided with the opportunity to offer
comments on the previous Determination, and these comments have been used to incorporate
improvements to the formatting and readability of the Determination and to the wording of
the requirements for ingredients, and also to help ensure that the list is comprehensive and
accurate. Engagement with industry on the implementation of the Determination is also
ongoing.
In early and mid-2016 the TGA also wrote to industry groups and to individual sponsors
potentially affected by the outcomes of safety evaluation reports for the ingredient
Sanguinaria canadensis. This correspondence outlined the TGAs intended course of action
to restrict the ingredients availability to homeopathic use only and to work with affected
sponsors to remove products from the Australian Register of Therapeutic Goods
(the Register).
The Office of Best Practice Regulation (OBPR) has advised that a regulatory impact
statement is not required in relation to addition of permitted ingredients (OBPR Ref. 14416), or
in relation to changes to the Determination to correct errors, clarify requirements and
ingredient names, or remove an ingredient to be in line with medicines scheduling decisions
contained in the Poisons Standard (Standard for the Uniform Scheduling of Medicines and
Poisons (SUSMP)) (OBPR Ref. 20999).
The Determination is a legislative instrument for the purposes of the Legislation Act 2003.
In relation to compatibility with human rights, it is considered that the Determination is
compatible with the human rights and freedoms recognised or declared in the international
instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011, and a
Statement of Compatibility setting that out in further detail is below.
STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS FOR A

LEGISLATIVE INSTRUMENT THAT DOES NOT RAISE ANY HUMAN RIGHTS
ISSUES
Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011
This legislative instrument is compatible with the human rights and freedoms recognised or
declared in the international instruments listed in section 3 of the
Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Legislative Instrument
The Therapeutic Goods (Permissible Ingredients) Determination No.2 of 2016
(the Determination) is made by the Minister under subsection 26BB(1) of the
Therapeutic Goods Act 1989. The Determination has the effect of specifying ingredients that
may be contained in a medicine listed in the Australian Register of Therapeutic Goods
(the Register) under section 26A of the Act, and requirements in relation to the inclusion of
those ingredients in such medicines. A person seeking to list a medicine in the Register under
section 26A of the Act must certify, when doing so, that the medicine does not contain an
ingredient that is not specified in the Determination, and that none of the requirements
specified in the Determination in relation to the ingredients contained in the medicine have
been contravened paragraphs 26A(2)(ca) and (cb) of the Act refer.
If a person incorrectly certifies as to these matters, the Secretary may cancel, or suspend, their
goods from the Register (paragraphs 30(1)(e) of the Act and 29D(1)(b) refer). Offences and
civil penalty provisions may also apply if a person makes a false or misleading statement in,
or in connection with, a certification of a matter under subsection 26A(2) of the Act
(including in relation to permissible ingredients and related requirements).
The Determination revokes and replaces the Therapeutic Goods (Permissible Ingredients)
Determination No.1 of 2016 (which commenced on 29 April 2016), and incorporates a
number of changes to the previous Determination. These include, for example, correcting a
number of unintended errors, making a number of requirements relating to the use of
particular ingredients clearer, introducing 38 new ingredients for use in listed medicines for
the first time and removing availability of one ingredient from use in such medicines.
Human rights implications
This legislative instrument does not engage any of the applicable rights or freedoms.
Conclusion
This legislative instrument is compatible with human rights as it does not raise any human
rights issues.
Lyndall Soper, delegate of the Minister for Health and Aged Care

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Therapeutic Goods (Permissible Ingredients)

Determination No. 2 of 2016

ingredients for the purposes of paragraph 26BB(1)(a) of the Act; and

requirements applying to those ingredients for the purposes of

Dated this 27 July 2016

Authorised Version F2016L01253 registered 01/08/2016

Permissible ingredients and requirements applying to those

Permissible ingredients and requirements applying to those ingredients under Table 1

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

Additional requirements applying to specified ingredients in Table 1 that are derived

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

Part 1 Interpretation of Table 1

H means a homoeopathic preparation ingredient.

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

Specific requirement(s) applying to

Permitted for use only in combination

If used in a fragrance the total

Permitted for use only in combination

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

concentration in a medicine must be

(S)- LACTIC ACID

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

- (SAME) 'Individuals who are using

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

from bipolar depression should not use

Permitted for use only in combination

Permitted for use only in combination

Permitted for use only in combination

Permitted for use only in combination

Permitted for use only in combination

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

must be no more than 1%.

Permitted for use only in combination

Permitted for use only in combination

Only for use in topical medicines for

Permitted for use only in combination

If used in a fragrance the total

If used in a flavour the total flavour

Permitted for use only in combination

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

must be no more than 1%.

Permitted for use only in combination

Permitted for use only in combination

Permitted for use only in combination

Permitted for use only in combination

Therapeutic Goods (Permissible Ingredients) Determination No. 2 of 2016

Authorised Version F2016L01253 registered 01/08/2016

concentration in a medicine must be

Permitted for use only in combination

The concentration in the medicine