Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient name

Purpose

Specific requirements

5085

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'.

5086

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.'

5087

ULEX EUROPAEUS

A, H

5088

ULMUS AMERICANA

A, H

5089

ULMUS CAMPESTRIS

A, H

5090

ULMUS GLABRA

A, H

5091

ULMUS MINOR

A, H

5092

ULMUS PARVIFOLIA

A, H

5093

ULMUS PUMILA

A, H

5094

ULMUS RUBRA

A, H

5095

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%.

5096

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

5097

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%.

5098

UMBELLULARIA CALIFORNICA

A, H

5099

UNCARIA GAMBIR

A, H

5100

UNCARIA RHYNCOPHYLLA

A, H

5101

UNCARIA SINENSIS

A, H

5102

UNCARIA TOMENTOSA

A, H

5103

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5104

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%.

5105

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%.

5106

UNDECENOIC ACID

E

5107

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%.

5108

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%.

5109

UNDECYLENAMIDE DEA

E

5110

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5111

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5112

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).

5113

URTICA DIOICA

A, E, H

5114

URTICA URENS

A, H

5115

USNEA BARBATA

A, H

5116

UVA URSI LEAF DRY

A, H

5117

UVA URSI LEAF POWDER

A, E, H

5118

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%.

5119

VACCARIA SEGATALIS

A, H

5120

VACCINIUM BRACTEATUM

A, H

5121

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%.

5122

VACCINIUM MACROCARPON

A, E, H

5123

VACCINIUM MYRTILLOIDES

A, H

5124

VACCINIUM MYRTILLUS

A, E, H

5125

VACCINIUM OXYCOCCUS

A, H

5126

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%.

5127

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%.

5128

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%.

5129

VALERIAN DRY

A, H

5130

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%.

5131

VALERIAN POWDER

A, H

5132

VALERIANA EDULIS

A, H

5133

VALERIANA OFFICINALIS

A, H

5134

VALERIANA SORBIFOLIA

A, H

5135

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%.

5136

VALINE

A, E

5137

VANADIUM

H

5138

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%.

5139

VANILLA DRY

A, E, H

5140

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%.

5141

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%.

5142

VANILLA PLANIFOLIA

A, E, H

5143

VANILLA POWDER

A, E, H

5144

VANILLA TAHITENSIS

A, H

5145

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%.

5146

VANILLIN

E

5147

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%.

5148

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%.

5149

VAT RED 1

E

Permitted for use only as a colour for topical use.

5150

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5151

VAT RED 5

E

Permitted for use only as a colour for topical use.

5152

VEGETABLE OIL

E

5153

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).'

5154

VEIN

H

Only for use as an active homoeopathic ingredient.

5155

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%.

5156

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%.

5157

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%.

5158

VERBASCUM DENSIFLORUM

A, H

5159

VERBASCUM THAPSUS

A, H

5160

VERBENA OFFICINALIS

A, H

5161

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%.

5162

VERONICA CHAMAEDRYS

A, H

5163

VERONICA OFFICINALIS

A, H

5164

VERONICASTRUM VIRGINICUM

A, E, H

5165

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%.

5166

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%.

5167

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%.

5168

VIBURNUM OPULUS

A, E, H

5169

VIBURNUM PRUNIFOLIUM

A, E, H

5170

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%.

5171

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5172

VIGNA RADIATA

A, H

5173

VIGNA UMBELLATA

A, H

5174

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%.

5175

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%

5176

VINCETOXICUM OFFICINALE

A, H

5177

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%.

5178

VIOLA ODORATA

A, E, H

5179

VIOLA TRICOLOR

A, H

5180

VIOLA YEDOENSIS

A, H

5181

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%.

5182

VIPER

H

Only for use as an active homoeopathic ingredient. 

5183

VISCUM ALBUM

A, E, H

5184

VISCUM COLORATUM

A, H

5185

VISCUM FLAVESCENS

A, H

5186

VITELLARIA PARADOXA

A, E, H

5187

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).

5188

VITEX NEGUNDO

A, H

5189

VITEX ROTUNDIFOLIA

A, H

5190

VITEX TRIFOLIA

A, H

5191

VITIS VINIFERA

A, E, H

5192

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5193

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%.

5194

WAHLENBERGIA GRACILIS

A, H

5195

WALNUT

E

5196

WALNUT OIL

E

5197

WATER MELON

E

5198

WHEAT

E

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

5199

WHEAT BRAN

E

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

5200

WHEAT DEXTRIN

A, E

Gluten is a mandatory component of wheat dextrin.

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

5201

WHEAT GERM

E

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

5202

WHEAT GERM GLYCERIDES

E

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

5203

WHEAT LEAF

E

5204

WHEAT SPROUT

E

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

5205

WHEAT STARCH

E

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

5206

WHEATGERM OIL

A, E, H

5207

WHEY POWDER

E

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

5208

WHEY PROTEIN

E

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

5209

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%.

5210

WHITE BEESWAX

E

5211

WHITE HOREHOUND HERB DRY

A, H

5212

WHITE HOREHOUND HERB POWDER

A, H

5213

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.

5214

WHOLE DRY MILK

E

5215

WIKSTROEMIA VIRIDIFLORA

A, H

5216

WILD CARROT HERB DRY

A, E, H

5217

WILD CARROT HERB POWDER

A, H

5218

WILD CHERRY BARK DRY

A, H

5219

WILD CHERRY BARK POWDER

A, H

5220

WILD LETTUCE LEAF DRY

A, H

5221

WILD LETTUCE LEAF POWDER

A, H

5222

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'.

5223

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.

5224

WOLFIPORIA COCOS

A, E, H

5225

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5226

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.

5227

XANTHAN GUM

E

5228

XANTHIUM SIBIRICUM

A, H

5229

XANTHIUM STRUMARIUM

A, H

5230

XANTHOMONA CAMPESTRIS

A, H

5231

XEROPHYLLUM ASPHODELOIDES

A, H

5232

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%.

5233

XYLITOL

E

5234

XYLOSE

E

5235

YAM

E

5236

YARROW HERB DRY

A, H

5237

YARROW HERB POWDER

A, H

5238

YEAST AUTOLYSATE

E

5239

YEAST DRIED

A, E, H

5240

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5241

YELLOW BEESWAX

E

5242

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5243

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.

5244

YLANG YLANG OIL

A, E, H

5245

YUCCA BACCATA

A, H

5246

YUCCA ELATA

A, H

5247

YUCCA FILAMENTOSA

A, H

5248

YUCCA GLORIOSA

A, H

5249

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.

5250

ZANTHOXYLUM AMERICANUM

A, H

5251

ZANTHOXYLUM BUNGEANUM

A, E, H

5252

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5253

ZANTHOXYLUM NITIDUM

A, H

5254

ZANTHOXYLUM PIPERITUM

A, H

5255

ZANTHOXYLUM SIMULANS

A, H

5256

ZEA MAYS

A, E, H

5257

ZEAXANTHIN

A, E

5258

ZEIN

E

5259

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)'.

5260

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).'

5261

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).'

5262

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)'.

5263

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).'

5264

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).'

5265

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).'

5266

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).'

5267

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).'

5268

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).'

5269

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).'

5270

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)'.

5271

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'.

5272

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'.

5273

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).'

5274

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).'

5275

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%.

5276

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).

5277

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).

5278

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.

5279

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).'

5280

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).'

5281

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).'

5282

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).'

5283

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).'

5284

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.

5285

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%.

5286

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'.

5287

ZIZIPHUS JUJUBA

A, H

5288

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5289

ZIZYPHUS SATIVA

A, H

5290

ZOSTERA MARINA

A, H

5291

ZUCCHINI

E