4981

UBIDECARENONE

A,E

When used as an excipient, the route of administration must be topical.

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

When used as an excipient, the concentration in a medicine must be no more than 0.05%.

The maximum recommended daily dose must provide no more than 300 milligrams of ubidecarenone.

When used in combination with Ubiquinol‑10, the maximum recommended daily dose must provide no more than 300 milligrams 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.'

4982

UBIQUINOL-10

A

Only for use in oral medicines.

The maximum recommended daily dose must provide no more than 300 mg 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.

requires the following warning statement on the medicine label:

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

4983

ULEX EUROPAEUS

A,H

4984

ULMUS AMERICANA

A,H

4985

ULMUS CAMPESTRIS

A,H

4986

ULMUS GLABRA

A,H

4987

ULMUS PARVIFOLIA

A,H

4988

ULMUS PROCERA

A,H

4989

ULMUS PUMILA

A,H

4990

ULMUS RUBRA

A,H

4991

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%.

4992

ULTRAMARINE BLUE

E

Permitted for use as a colour for topical use.

4993

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%.

4994

UNCARIA GAMBIR

A,H

4995

UNCARIA RHYNCOPHYLLA

A,H

4996

UNCARIA SINENSIS

A,H

4997

UNCARIA TOMENTOSA

A,H

4998

UNDARIA PINNATIFIDA

A,H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

4999

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%.

5000

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%.

5001

UNDECENOIC ACID

E

5002

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%.

5003

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%.

5004

UNDECYLENAMIDE DEA

E

5005

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5006

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5007

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).

5008

URTICA DIOICA

A,E,H

5009

URTICA URENS

A,H

5010

USNEA BARBATA

A,H

5011

UVA URSI LEAF DRY

A,H

5012

UVA URSI LEAF POWDER

A,E,H

5013

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%.

5014

VACCARIA SEGATALIS

A,H

5015

VACCINIUM BRACTEATUM

A,H

5016

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%.

5017

VACCINIUM MACROCARPON

A,E,H

5018

VACCINIUM MYRTILLOIDES

A,H

5019

VACCINIUM MYRTILLUS

A,E,H

5020

VACCINIUM OXYCOCCUS

A,H

5021

VACCINIUM VITIS-IDAEA

A,H

5022

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%.

5023

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%.

5024

VALERIAN DRY

A,H

5025

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%.

5026

VALERIAN POWDER

A,H

5027

VALERIANA EDULIS

A,H

5028

VALERIANA OFFICINALIS

A,H

5029

VALERIANA SORBIFOLIA

A,H

5030

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%.

5031

VALINE

A,E

5032

VANADIUM

H

5033

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%.

5034

VANILLA DRY

A,E,H

5035

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%.

5036

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%.

5037

VANILLA PLANIFOLIA

A,E,H

5038

VANILLA POWDER

A,E,H

5039

VANILLA TAHITENSIS

A,H

5040

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%.

5041

VANILLIN

E

Permitted for use as a flavour.

5042

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%.

5043

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%.

5044

VAT RED 1

E

Permitted for use as a colour for topical use.

5045

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use as a colour for topical use.

5046

VAT RED 5

E

Permitted for use as a colour for topical use.

5047

VEGETABLE OIL

E

5048

VEGETABLE OIL PHYTOSTEROL ESTERS

A

Only for use in oral medicines.

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

- (VOPE) 'There is no benefit from taking more than 3g/day of phytosterols from all sources'

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

5049

VEIN

H

Only for use as an active homoeopathic ingredient.

5050

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%.

5051

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%.

5052

VERBASCUM DENSIFLORUM

A,H

5053

VERBASCUM THAPSUS

A,H

5054

VERBENA OFFICINALIS

A,H

5055

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%.

5056

VERONICA CHAMAEDRYS

A,H

5057

VERONICA OFFICINALIS

A,H

5058

VERONICASTRUM VIRGINICUM

A,E,H

5059

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%.

5060

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%.

5061

VIBURNUM OPULUS

A,E,H

5062

VIBURNUM PRUNIFOLIUM

A,E,H

5063

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%.

5064

VIGNA ANGULARIS VAR. ANGULARIS

A,H

5065

VIGNA RADIATA

A,H

5066

VIGNA UMBELLATA

A,H

5067

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%.

5068

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%

5069

VINCETOXICUM OFFICINALE

A,H

5070

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%.

5071

VIOLA ODORATA

A,E,H

5072

VIOLA TRICOLOR

A,H

5073

VIOLA YEDOENSIS

A,H

5074

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%.

5075

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%.

5076

VIPER

H

Only for use as an active homoeopathic ingredient. 

5077

VISCUM ALBUM

A,E,H

5078

VISCUM COLORATUM

A,H

5079

VISCUM FLAVESCENS

A,H

5080

VITELLARIA PARADOXA

A,E,H

5081

VITEX AGNUS-CASTUS

A,E,H

5082

VITEX NEGUNDO

A,H

5083

VITEX ROTUNDIFOLIA

A,H

5084

VITEX TRIFOLIA

A,H

5085

VITIS VINIFERA

A,E,H

5086

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5087

WAHLENBERGIA GRACILIS

A,H

5088

WALNUT

E

5089

WALNUT OIL

E

5090

WATER MELON

E

5091

WHEAT

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5092

WHEAT BRAN

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5093

WHEAT DEXTRIN

A,E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5094

WHEAT GERM

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5095

WHEAT GERM GLYCERIDES

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5096

WHEAT LEAF

E

5097

WHEAT SPROUT

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5098

WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of –Wheat Starch.

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).

5099

WHEATGERM OIL

A,E,H

5100

WHEY POWDER

E

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

5101

WHEY PROTEIN

E

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

5102

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%.

5103

WHITE BEESWAX

E

5104

WHITE HOREHOUND HERB DRY

A,H

5105

WHITE HOREHOUND HERB POWDER

A,H

5106

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.

5107

WIKSTROEMIA VIRIDIFLORA

A,H

5108

WILD CARROT HERB DRY

A,E,H

5109

WILD CARROT HERB POWDER

A,H

5110

WILD CHERRY BARK DRY

A,H

5111

WILD CHERRY BARK POWDER

A,H

5112

WILD LETTUCE LEAF DRY

A,H

5113

WILD LETTUCE LEAF POWDER

A,H

5114

WINTERGREEN OIL

A,E,H

Methyl salicylate is a mandatory component of Wintergreen oil.

The concentration of Methyl salicylate in the medicine must be no 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 but the delivery device must be engaged into the container in such a way that prevents it from being readily removed, direct suction through the delivery device results in delivery of no more than one dosage unit, and actuation of the spay device is ergonomically difficult for young children to accomplish.

5115

WITHANIA SOMNIFERA

A,E,H

5116

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5117

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.

5118

XANTHAN GUM

E

5119

XANTHIUM SIBIRICUM

A,H

5120

XANTHIUM STRUMARIUM

A,H

5121

XANTHOMONA CAMPESTRIS

A,H

5122

XEROPHYLLUM ASPHODELOIDES

A,H

5123

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%.

5124

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]’.

5125

XYLOSE

E

5126

YAM

E

5127

YARROW HERB DRY

A,H

5128

YARROW HERB POWDER

A,H

5129

YEAST AUTOLYSATE

E

5130

YEAST DRIED

A,E,H

5131

YELLOW 2G

E

Permitted for use as a colour for topical use.

5132

YELLOW BEESWAX

E

5133

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5134

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.

5135

YLANG YLANG OIL

A,E,H

5136

YUCCA BACCATA

A,H

5137

YUCCA ELATA

A,H

5138

YUCCA FILAMENTOSA

A,H

5139

YUCCA GLORIOSA

A,H

5140

YUCCA WHIPPLEI

A,H

5141

ZANTHOXYLUM AMERICANUM

A,H

5142

ZANTHOXYLUM BUNGEANUM

A,E,H

5143

ZANTHOXYLUM CLAVA-HERCULIS

A,H

5144

ZANTHOXYLUM NITIDUM

A,H

5145

ZANTHOXYLUM PIPERITUM

A,H

5146

ZANTHOXYLUM SIMULANS

A,H

5147

ZEA MAYS

A,E,H

5148

ZEAXANTHIN

A,E

5149

ZEIN

E

5150

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)'.

5151

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%.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

5152

ZINC ASCORBATE

A,E,H

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

The percentage of zinc from zinc ascorbate should be calculated based on the molecular weight 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)'.                                                                                                                                                  

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

5153

ZINC ASCORBATE MONOHYDRATE

A,E,H

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

The percentage of zinc from Zinc ascorbate monohydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5154

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. The percentage of zinc from zinc chloride should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           

5155

ZINC CITRATE

A,E,H

When used internally, zinc is a mandatory component of zinc citrate . The percentage of zinc from zinc citrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.                 

5156

ZINC CITRATE DIHYDRATE

A,E,H

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

The percentage of zinc from zinc citrate dihydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           

5157

ZINC CITRATE TRIHYDRATE

A,E,H

When used internally, zinc is a mandatory component of zinc citrate trihydrate. The percentage of zinc from Zinc citrate trihydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5158

ZINC DIASPARTATE

A

When used internally, zinc is a mandatory component of zinc diaspartate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc diaspartate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5159

ZINC GLUCONATE

A,E,H

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

The percentage of zinc from Zinc gluconate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5160

ZINC GLYCINATE

A

When used internally, zinc is a mandatory component of Zinc glycinate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc glycinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5161

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'.

5162

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'.

5163

ZINC LYSINATE

A

When used internally, zinc is a mandatory component of Zinc lysinate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc lysinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5164

ZINC METHIONINE SULFATE

A

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

When used internally, zinc is a mandatory component of Zinc methionine sulfate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc methionine sulfate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5165

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%.

5166

ZINC OXIDE

A,E,H

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

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

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

5167

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-phenolsulfonate.

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

5168

ZINC STEARATE

E

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

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

5169

ZINC SUCCINATE

A,E,H

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

The percentage of zinc from Zinc succinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5170

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.

The percentage of zinc from Zinc sulfate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5171

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.

The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5172

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.

The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5173

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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5174

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.

5175

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%.

5176

ZINGIBER OFFICINALE

A,E,H

When for oral use AND the extract ratio is equal to or more than 25:1 OR the equivalent dry weight per dosage unit is equal to OR more than 2g,  the 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'

5177

ZIZIPHUS JUJUBA

A,H

5178

ZIZIPHUS JUJUBA VAR. SPINOSA

A,H

5179

ZIZYPHUS SATIVA

A,H

5180

ZOSTERA MARINA

A,H

5181

ZUCCHINI

E