Federal Register of Legislation - Australian Government

Primary content

Determinations/Health as made
This instrument repeals and replaces the Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019, and specifies those ingredients that may be contained in a medicine that is listed in the Australian Register of Therapeutic Goods, and requirements in relation to the inclusion of those ingredients in such medicines.
Administered by: Health
Registered 18 Nov 2019
Tabling HistoryDate
Tabled HR25-Nov-2019
Tabled Senate25-Nov-2019
Date of repeal 01 Jan 2020
Repealed by Therapeutic Goods (Permissible Ingredients) Determination (No. 4) 2019
Table of contents.

Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

Note:       See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

5039

UBIDECARENONE

A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone.

When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined.

When for internal use, the following warning statement is required on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice'.

 

5040

UBIQUINOL-10

A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10.

When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.

The medicine requires the following warning statement on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice.'

 

5041

ULEX EUROPAEUS

A, H

 

5042

ULMUS AMERICANA

A, H

 

5043

ULMUS CAMPESTRIS

A, H

 

5044

ULMUS GLABRA

A, H

 

5045

ULMUS PARVIFOLIA

A, H

 

5046

ULMUS PROCERA

A, H

 

5047

ULMUS PUMILA

A, H

 

5048

ULMUS RUBRA

A, H

 

5049

ULTRALIDE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

5050

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

 

5051

ULVA LACTUCA

A, H

Iodine is a mandatory component of Ulva lactuca.

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.

 

5052

UMBELLULARIA CALIFORNICA

A, H

 

5053

UNCARIA GAMBIR

A, H

 

5054

UNCARIA RHYNCOPHYLLA

A, H

 

5055

UNCARIA SINENSIS

A, H

 

5056

UNCARIA TOMENTOSA

A, H

 

5057

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

 

5058

UNDECANAL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5059

UNDECANOIC ACID

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used as a flavour the total flavour concentration in a medicine must be no more than 5%.

 

5060

UNDECENOIC ACID

E

 

5061

UNDECYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5062

UNDECYLCRYLENE DIMETICONE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 10%.

 

5063

UNDECYLENAMIDE DEA

E

 

5064

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

 

5065

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

 

5066

UREA

A, E, H

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10% (w/w).

 

5067

URTICA DIOICA

A, E, H

 

5068

URTICA URENS

A, H

 

5069

USNEA BARBATA

A, H

 

5070

UVA URSI LEAF DRY

A, H

 

5071

UVA URSI LEAF POWDER

A, E, H

 

5072

VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER

E

Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer.

The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm.

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 5%.

 

5073

VACCARIA SEGATALIS

A, H

 

5074

VACCINIUM BRACTEATUM

A, H

 

5075

VACCINIUM CORYMBOSUM

E

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%.

 

5076

VACCINIUM MACROCARPON

A, E, H

 

5077

VACCINIUM MYRTILLOIDES

A, H

 

5078

VACCINIUM MYRTILLUS

A, E, H

 

5079

VACCINIUM OXYCOCCUS

A, H

 

5080

VACCINIUM VITIS-IDAEA

A, H

Arbutin is a mandatory component of Vaccinium vitis-idaea.

The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair.

When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.

 

5081

VALENCENE

E

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%.

 

5082

VALERALDEHYDE

E

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%.

 

 

5083

VALERIAN DRY

A, H

 

5084

VALERIAN OIL

E

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%.

 

5085

VALERIAN POWDER

A, H

 

5086

VALERIANA EDULIS

A, H

 

5087

VALERIANA OFFICINALIS

A, H

 

5088

VALERIANA SORBIFOLIA

A, H

 

5089

VALERIC ACID

E

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%.

 

5090

VALINE

A, E

 

5091

VANADIUM

H

 

5092

VANILLA

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5093

VANILLA DRY

A, E, H

 

5094

VANILLA EXTRACT

E

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%.

 

5095

VANILLA OLEORESIN

E

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%.

 

5096

VANILLA PLANIFOLIA

A, E, H

 

5097

VANILLA POWDER

A, E, H

 

5098

VANILLA TAHITENSIS

A, H

 

5099

VANILLIC ACID

E

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%.

 

5100

VANILLIN

E

 

5101

VANILLIN ISOBUTYRATE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5102

VANILLYL ALCOHOL

E

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%.

 

5103

VAT RED 1

E

Permitted for use only as a colour for topical use.

 

5104

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

 

5105

VAT RED 5

E

Permitted for use only as a colour for topical use.

 

5106

VEGETABLE OIL

E

 

5107

VEGETABLE OIL PHYTOSTEROL ESTERS

A

Only for use in oral medicines.

The medicine requires the following warning statement on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).'

 

5108

VEIN

H

Only for use as an active homoeopathic ingredient.

 

5109

VERATRALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5110

VERATROL

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

5111

VERATRUM ALBUM

A, H

Solanidine is a mandatory component of Veratrum album.

The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

 

5112

VERBASCUM DENSIFLORUM

A, H

 

5113

VERBASCUM THAPSUS

A, H

 

5114

VERBENA OFFICINALIS

A, H

 

5115

VERBENA OIL

E

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%.

 

5116

VERONICA CHAMAEDRYS

A, H

 

5117

VERONICA OFFICINALIS

A, H

 

5118

VERONICASTRUM VIRGINICUM

A, E, H

 

5119

VERTONAL

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

When included in a medicine for use on the lips the concentration of vertonal must be no more than 0.2%.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

5120

VETIVER OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5121

VETIVERYL ACETATE

E

Permitted for use only in combination with other permitted ingredients as a fragrance.

If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%.

 

5122

VIBURNUM OPULUS

A, E, H

 

5123

VIBURNUM PRUNIFOLIUM

A, E, H

 

5124

VICIA FABA

A, H

Levodopa (of Vicia faba) is a mandatory component of Vicia faba.

The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.

 

5125

VIGNA ANGULARIS VAR. ANGULARIS

A, H

 

5126

VIGNA RADIATA

A, H

 

5127

VIGNA UMBELLATA

A, H

 

5128

VINCA MAJOR

A, H

Vincamine is a mandatory component of Vinca major.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

 

5129

VINCA MINOR

A, H

Vincamine and vincristine are mandatory components of Vinca minor.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%

 

5130

VINCETOXICUM OFFICINALE

A, H

 

5131

VINEGAR

E

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%.

 

5132

VIOLA ODORATA

A, E, H

 

5133

VIOLA TRICOLOR

A, H

 

5134

VIOLA YEDOENSIS

A, H

 

5135

VIOLET LEAF ABSOLUTE

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

 

5136

VIOLET LEAVES

E

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%.

 

5137

VIPER

H

Only for use as an active homoeopathic ingredient. 

 

5138

VISCUM ALBUM

A, E, H

 

5139

VISCUM COLORATUM

A, H

 

5140

VISCUM FLAVESCENS

A, H

 

5141

VITELLARIA PARADOXA

A, E, H

 

5142

VITEX AGNUS-CASTUS

A, E, H

 

5143

VITEX NEGUNDO

A, H

 

5144

VITEX ROTUNDIFOLIA

A, H

 

5145

VITEX TRIFOLIA

A, H

 

5146

VITIS VINIFERA

A, E, H

 

5147

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.

 

5148

VP/ACRYLATES/LAURYL METHACRYLATE COPOLYMER

E

Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye.

The concentration in the medicine must not be more than 2.00%.

 

5149

WAHLENBERGIA GRACILIS

A, H

 

5150

WALNUT

E

 

5151

WALNUT OIL

E

 

5152

WATER MELON

E

 

5153

WHEAT

E

Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.

 

5154

WHEAT BRAN

E

Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.

 

5155

WHEAT DEXTRIN

A, E

Gluten is a mandatory component of wheat dextrin.

Only for use when the dosage form is capsule, tablet or pill.

 

5156

WHEAT GERM

E

Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.

 

5157

WHEAT GERM GLYCERIDES

E

Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.

 

5158

WHEAT LEAF

E

 

5159

WHEAT SPROUT

E

Gluten is a mandatory component of Wheat sprout when the route of administration is other than topical and mucosal.

 

5160

WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.

 

5161

WHEATGERM OIL

A, E, H

 

5162

WHEY POWDER

E

Lactose is a mandatory component of Whey powder when the route of administration is oral.

 

5163

WHEY PROTEIN

E

Lactose is a mandatory component of Whey protein when the route of administration is oral.

 

5164

WHEY PROTEIN CONCENTRATE

E

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%.

 

5165

WHITE BEESWAX

E

 

5166

WHITE HOREHOUND HERB DRY

A, H

 

5167

WHITE HOREHOUND HERB POWDER

A, H

 

5168

WHITE SOFT PARAFFIN

A, E

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 Pharmacopoeia, as in force or existing from time to time.

 

5169

WHOLE DRY MILK

E

If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label:

- (LACT) 'Contains lactose' (or words to that effect).

 

5170

WIKSTROEMIA VIRIDIFLORA

A, H

 

5171

WILD CARROT HERB DRY

A, E, H

 

5172

WILD CARROT HERB POWDER

A, H

 

5173

WILD CHERRY BARK DRY

A, H

 

5174

WILD CHERRY BARK POWDER

A, H

 

5175

WILD LETTUCE LEAF DRY

A, H

 

5176

WILD LETTUCE LEAF POWDER

A, H

 

5177

WINTERGREEN OIL

A, E, H

Methyl salicylate is a mandatory component of wintergreen oil.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be more than 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.

When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is 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 spray device is ergonomically difficult for young children to accomplish.

In addition, when the ingredient is included in a medicine that is listed in the Register:

- on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b);

- before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or

- before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with the requirements under (a) & (b).

a) The following warning statement is required on the medicine label:

- (METSAL) 'Contains methyl salicylate' (or words to that effect).

b) When for use in topical medicines for dermal application, the concentration of methyl salicylate in the medicine must not be more than 25% and the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight'. (or words to that effect);

- (IRRIT) 'If irritation develops, discontinue use.'; and

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect).

 

5178

WITHANIA SOMNIFERA

A, E, H

 

5179

WOLFIPORIA COCOS

A, E, H

When the ingredient is included in a medicine that is listed in the Register before 1 July 2018 and supplied before 1 January 2020, the medicine label may refer to the ingredient name as 'Poria cocos' instead of 'Wolfiporia cocos'.

 

5180

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

 

5181

WOOL FAT

A, E

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 Pharmacopoeia, as in force or existing from time to time.

 

5182

XANTHAN GUM

E

 

5183

XANTHIUM SIBIRICUM

A, H

 

5184

XANTHIUM STRUMARIUM

A, H

 

5185

XANTHOMONA CAMPESTRIS

A, H

 

5186

XEROPHYLLUM ASPHODELOIDES

A, H

 

5187

XYLENE

E

The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose.

 The concentration in the medicine must be no more than 0.217%.

 

5188

XYLITOL

E

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 following warning statement on 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]’.

 

5189

XYLOSE

E

 

5190

YAM

E

 

5191

YARROW HERB DRY

A, H

 

5192

YARROW HERB POWDER

A, H

 

5193

YEAST AUTOLYSATE

E

 

5194

YEAST DRIED

A, E, H

 

5195

YELLOW 2G

E

Permitted for use only as a colour for topical use.

 

5196

YELLOW BEESWAX

E

 

5197

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

 

5198

YELLOW SOFT PARAFFIN

A, E

Only for use in topical medicines for dermal application.

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 Pharmacopoeia, as in force or existing from time to time.

 

5199

YLANG YLANG OIL

A, E, H

 

5200

YUCCA BACCATA

A, H

 

5201

YUCCA ELATA

A, H

 

5202

YUCCA FILAMENTOSA

A, H

 

5203

YUCCA GLORIOSA

A, H

 

5204

YUCCA WHIPPLEI

A, H

 

5205

ZANTHOXYLUM AMERICANUM

A, H

 

5206

ZANTHOXYLUM BUNGEANUM

A, E, H

 

5207

ZANTHOXYLUM CLAVA-HERCULIS

A, H

 

5208

ZANTHOXYLUM NITIDUM

A, H

 

5209

ZANTHOXYLUM PIPERITUM

A, H

 

5210

ZANTHOXYLUM SIMULANS

A, H

 

5211

ZEA MAYS

A, E, H

 

5212

ZEAXANTHIN

A, E

 

5213

ZEIN

E

 

5214

ZINC

H

Only for use as an active homoeopathic ingredient.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect)'.

 

5215

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%.

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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

 

5216

ZINC ASCORBATE

A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5217

ZINC ASCORBATE MONOHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.

 When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect)'.

 

5218

ZINC CHLORIDE

A, E, H

The concentration of zinc chloride in the medicine must be no more than 5%.

When used internally, zinc is a mandatory component of zinc chloride.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5219

ZINC CITRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5220

ZINC CITRATE DIHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate dihydrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5221

ZINC CITRATE TRIHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate trihydrate.  When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5222

ZINC DIASPARTATE

A

When used internally, zinc is a mandatory component of zinc diaspartate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5223

ZINC GLUCONATE

A, E, H

When used internally, zinc is a mandatory component of zinc gluconate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5224

ZINC GLYCINATE

A

When used internally, zinc is a mandatory component of Zinc glycinate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5225

ZINC GLYCINATE MONOHYDRATE

A

When used internally, zinc is a mandatory component of Zinc glycinate monohydrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect)'.

 

5226

ZINC LACTATE

E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

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 warning statement on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.

 

5227

ZINC LACTATE DIHYDRATE

E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

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 less than 12 years old.

 Medicines containing Zinc lactate for dental use require the following warning statement on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.

 

5228

ZINC LYSINATE

A

When used internally, zinc is a mandatory component of Zinc lysinate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5229

ZINC METHIONINE SULFATE

A

For topical use, the concentration of zinc methionine sulfate must be no more than 5%.

When used internally, zinc is a mandatory component of zinc methionine sulfate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5230

ZINC MYRISTATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must be no more than 0.1%.

 

5231

ZINC OXIDE

A, E, H

When used internally, zinc is a mandatory component of zinc oxide.

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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

 

5232

ZINC PARA-PHENOLSULFONATE

E

The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%.

When used internally, zinc is a mandatory component of zinc para-phenolsulfate.

The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.

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 following warning statement on 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 dangerous if taken in large amounts or for a long period' (or words to that effect).

 

5233

ZINC STEARATE

E

When used internally, zinc is a mandatory component of zinc stearate.

The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.

 

5234

ZINC SUCCINATE

A, E, H

When used internally, zinc is a mandatory component of zinc succinate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5235

ZINC SULFATE

A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

 

5236

ZINC SULFATE HEPTAHYDRATE

A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

 

5237

ZINC SULFATE HEXAHYDRATE

A, E, H

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

5238

ZINC SULFATE MONOHYDRATE

A, E, H

When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.

When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.

When for internal use, the maximum recommended daily dose must be no 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 following warning statement on 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 dangerous if taken in large amounts or for a long period (or words to that effect).'

 

 

5239

ZINC VALERATE

H

Only for use as an active homoeopathic ingredient.

For internal use, zinc is a mandatory component of zinc valerate.

The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.

 

5240

ZINGERONE

E

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%.

 

5241

ZINGIBER OFFICINALE

A, E, H

When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine 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'.

 

5242

ZIZIPHUS JUJUBA

A, H

 

5243

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

 

5244

ZIZYPHUS SATIVA

A, H

 

5245

ZOSTERA MARINA

A, H

 

5246

ZUCCHINI

E

 


Schedule 2—Repeals

Note:       See section 7.

Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2019

1  The whole of the instrument

Repeal the instrument.