Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

5062

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'.

5063

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.'

5064

ULEX EUROPAEUS

A, H

5065

ULMUS AMERICANA

A, H

5066

ULMUS CAMPESTRIS

A, H

5067

ULMUS GLABRA

A, H

5068

ULMUS MINOR

A, H

5069

ULMUS PARVIFOLIA

A, H

5070

ULMUS PUMILA

A, H

5071

ULMUS RUBRA

A, H

5072

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%.

5073

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

5074

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%.

5075

UMBELLULARIA CALIFORNICA

A, H

5076

UNCARIA GAMBIR

A, H

5077

UNCARIA RHYNCOPHYLLA

A, H

5078

UNCARIA SINENSIS

A, H

5079

UNCARIA TOMENTOSA

A, H

5080

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5081

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%.

5082

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%.

5083

UNDECENOIC ACID

E

5084

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%.

5085

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%.

5086

UNDECYLENAMIDE DEA

E

5087

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5088

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5089

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).

5090

URTICA DIOICA

A, E, H

5091

URTICA URENS

A, H

5092

USNEA BARBATA

A, H

5093

UVA URSI LEAF DRY

A, H

5094

UVA URSI LEAF POWDER

A, E, H

5095

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%.

5096

VACCARIA SEGATALIS

A, H

5097

VACCINIUM BRACTEATUM

A, H

5098

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%.

5099

VACCINIUM MACROCARPON

A, E, H

5100

VACCINIUM MYRTILLOIDES

A, H

5101

VACCINIUM MYRTILLUS

A, E, H

5102

VACCINIUM OXYCOCCUS

A, H

5103

VACCINIUM VITIS-IDAEA

A, H

Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

5104

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%.

5105

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%.

5106

VALERIAN DRY

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5107

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%.

5108

VALERIAN POWDER

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5109

VALERIANA EDULIS

A, H

5110

VALERIANA OFFICINALIS

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5111

VALERIANA SORBIFOLIA

A, H

5112

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%.

5113

VALINE

A, E

5114

VANADIUM

H

5115

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%.

5116

VANILLA DRY

A, E, H

5117

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%.

5118

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%.

5119

VANILLA PLANIFOLIA

A, E, H

5120

VANILLA POWDER

A, E, H

5121

VANILLA TAHITENSIS

A, H

5122

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%.

5123

VANILLIN

E

5124

VANILLIN ACETATE

E

Vanillin acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing vanillin acetate must not be more than 5% of the total medicine.

The maximum recommended daily dose of the medicine must not provide more than 1.8 micrograms of vanillin acetate.

5125

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%.

5126

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%.

5127

VAT RED 1

E

Permitted for use only as a colour for topical use.

5128

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5129

VAT RED 5

E

Permitted for use only as a colour for topical use.

5130

VEGETABLE OIL

E

5131

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).'

5132

VEIN

H

Only for use as an active homoeopathic ingredient.

5133

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%.

5134

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%.

5135

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%.

5136

VERBASCUM DENSIFLORUM

A, H

5137

VERBASCUM THAPSUS

A, H

5138

VERBENA OFFICINALIS

A, H

5139

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%.

5140

VERONICA CHAMAEDRYS

A, H

5141

VERONICA OFFICINALIS

A, H

5142

VERONICASTRUM VIRGINICUM

A, E, H

5143

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%.

5144

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%.

5145

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%.

5146

VIBURNUM OPULUS

A, E, H

5147

VIBURNUM PRUNIFOLIUM

A, E, H

5148

VICIA FABA

A, H

Levodopa is a mandatory component of Vicia faba.

The concentration of levodopa in the  medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

5149

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5150

VIGNA RADIATA

A, H

5151

VIGNA UMBELLATA

A, H

5152

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%.

5153

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%

5154

VINCETOXICUM OFFICINALE

A, H

5155

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%.

5156

VIOLA ODORATA

A, E, H

5157

VIOLA TRICOLOR

A, H

5158

VIOLA YEDOENSIS

A, H

5159

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 than 1%.

5160

VIPER

H

Only for use as an active homoeopathic ingredient. 

5161

VISCUM ALBUM

A, E, H

5162

VISCUM COLORATUM

A, H

5163

VISCUM FLAVESCENS

A, H

5164

VITELLARIA PARADOXA

A, E, H

5165

VITEX AGNUS-CASTUS

A, E, H

When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label:

- (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).

5166

VITEX NEGUNDO

A, H

5167

VITEX ROTUNDIFOLIA

A, H

5168

VITEX TRIFOLIA

A, H

5169

VITIS VINIFERA

A, E, H

5170

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5171

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%.

5172

WAHLENBERGIA GRACILIS

A, H

5173

WALNUT

E

5174

WALNUT OIL

E

5175

WATER MELON

E

5176

WHEAT

E

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

5177

WHEAT BRAN

E

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

5178

WHEAT DEXTRIN

A, E

Gluten is a mandatory component of wheat dextrin.

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

5179

WHEAT GERM

E

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

5180

WHEAT GERM GLYCERIDES

E

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

5181

WHEAT LEAF

E

5182

WHEAT STARCH

E

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

5183

WHEATGERM OIL

A, E, H

5184

WHEY POWDER

E

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

5185

WHEY PROTEIN

E

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

5186

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%.

5187

WHITE BEESWAX

E

5188

WHITE HOREHOUND HERB DRY

A, H

5189

WHITE HOREHOUND HERB POWDER

A, H

5190

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.

5191

WHOLE DRY MILK

E

5192

WIKSTROEMIA VIRIDIFLORA

A, H

5193

WILD CARROT HERB DRY

A, E, H

5194

WILD CARROT HERB POWDER

A, H

5195

WILD CHERRY BARK DRY

A, H

5196

WILD CHERRY BARK POWDER

A, H

5197

WILD LETTUCE LEAF DRY

A, H

5198

WILD LETTUCE LEAF POWDER

A, H

5199

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.

The following warning statement is required on the medicine label:

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

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%;

ii) 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);

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

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

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

5200

WITHANIA SOMNIFERA

A, E, H

The medicine requires the following warning statement on the label:

- (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)

unless:

(a) the plant part is root;

(b) the plant preparation is an extract;

(c) the extraction solvents are only water, ethanol or methanol; and

(d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.

5201

WOLFIPORIA COCOS

A, E, H

5202

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5203

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.

5204

XANTHAN GUM

E

5205

XANTHIUM SIBIRICUM

A, H

5206

XANTHIUM STRUMARIUM

A, H

5207

XANTHOMONA CAMPESTRIS

A, H

5208

XEROPHYLLUM ASPHODELOIDES

A, H

5209

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%.

5210

XYLITOL

E

5211

XYLOSE

E

5212

YAM

E

5213

YARROW HERB DRY

A, H

5214

YARROW HERB POWDER

A, H

5215

YEAST AUTOLYSATE

E

5216

YEAST DRIED

A, E, H

5217

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5218

YELLOW BEESWAX

E

5219

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5220

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.

5221

YLANG YLANG OIL

A, E, H

5222

YUCCA BACCATA

A, H

5223

YUCCA ELATA

A, H

5224

YUCCA FILAMENTOSA

A, H

5225

YUCCA GLORIOSA

A, H

5226

Z-BETA-DAMASCONE

E

Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine.

5227

ZANTHOXYLUM AMERICANUM

A, H

5228

ZANTHOXYLUM BUNGEANUM

A, E, H

5229

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5230

ZANTHOXYLUM NITIDUM

A, H

5231

ZANTHOXYLUM PIPERITUM

A, H

5232

ZANTHOXYLUM SIMULANS

A, H

5233

ZEA MAYS

A, E, H

5234

ZEAXANTHIN

A, E

5235

ZEIN

E

5236

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)'.

5237

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).'

5238

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).'

5239

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)'.

5240

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).'

5241

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).'

5242

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).'

5243

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).'

5244

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).'

5245

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).'

5246

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).'

5247

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)'.

5248

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 not be more than 2%.

The concentration of zinc lactate in a medicine for 'dental' use in toothpaste medicines must not be 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 (or words to the same effect) on the medicine label:

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

5249

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 not be more than 2%.

The concentration of zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must not be 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 dihydrate for dental use require the following warning statement (or words to the same effect) on the medicine label:

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

5250

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).'

5251

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).'

5252

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%.

5253

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, the following warning statements are required on the 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).

5254

ZINC PARA-PHENOLSULFONATE

E

Only permitted for use in topical medicines for dermal use.

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

5255

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.

When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc.

When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’.

5256

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).'

5257

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).'

5258

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).'

5259

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).'

5260

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).'

5261

ZINC VALERATE

H

Only for use as an active homoeopathic ingredient.

When 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.

When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc.

When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’.

5262

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%.

5263

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'.

5264

ZIZIPHUS JUJUBA

A, H

5265

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5266

ZIZYPHUS SATIVA

A, H

5267

ZOSTERA MARINA

A, H