Column 1

Column 2

Ingredient Name

Column 3

Purpose of the ingredient in the medicine

Column 4

Specific requirement(s) applying to the ingredient in Column 2

715

BACKHOUSIA CITRIODORA

A,E,H

The herbal substance must be derived from leaf oil only.

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10g/kg or 10g/L or 1%.

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

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

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

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

716

BACOPA MONNIERI

A,H

717

BALLOTA NIGRA

A,H

718

BALM OF GILEAD BUD DRY

A,H

719

BALM OF GILEAD BUD POWDER

A,H

720

BALSAM COPAIBA

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%.

721

BAMBUSA BREVIFLORA

A,E,H

722

BAMBUSA TEXTILIS

A,H

723

BANANA

E

724

BANANA DISTILLATE

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%.

725

BAPHICACANTHUS CUSIA

A,H

726

BAPTISIA CONFUSA

A,H

727

BAPTISIA TINCTORIA

A,H

728

BARBAREA VULGARIS

A,H

729

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

730

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

731

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

732

BARLEY

E

Gluten is a mandatory component of Barley 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.

733

BARLEY BRAN

E

Gluten is a mandatory component of Barley 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.

734

BARLEY GERM

E

Gluten is a mandatory component of Barley 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.

735

BARLEY LEAF

E

736

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

737

BASIC FUCHSIN

E

Only for use as a colour ingredient in topical medicines for dermal application.

738

BASIC RED 1

E

Only for use as a colour in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin.

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

739

BASIC VIOLET 11:1

E

Only for use as a colour in topical medicines for dermal application and not intended for use in the eye or on damaged skin.

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

740

BASIL OIL COMOROS

A,E,H

Methyl chavicol is a mandatory component of Basil oil Comoros.

When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL.

When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

741

BASIL OIL EUROPEAN

A,E,H

Methyl chavicol is a mandatory component of Basil oil European.

When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL.

When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

742

BASSIA SCOPARIA

A,H

743

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

744

BAY LEAF

E

745

BAY OIL

A,E,H

When the concentration of Bay oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is no more than 15 mL, there must be a restricted flow insert fitted on the container.

When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container.

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

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

746

BEESWAX - SYNTHETIC

E

747

BEESWAX - WHITE

E

748

BEESWAX - YELLOW

E

749

BEESWAX 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%.

750

BEET RED

E

Permitted for use as a colour for oral and topical use.

751

BEETROOT

E,H

752

BEGONIA FIMBRISTIPULA

A,H

753

BEHENETH-10

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 be no more than 1.5%.

Residual levels of ethylene oxide are to be kept below the level of detection.

754

BEHENIC ACID

E

If used as an excipient ingredient, the ingredient can only be in topical medicines for dermal application.

If the medicine is for oral ingestion, it must not contain more than 383.5 mg of behenic acid per maximum recommended daily dose.

755

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

756

BEHENOYL STEARIC ACID

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 be no more than 2.4%.

757

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

758

BELLADONNA HERB DRY

A,H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb dry.

The concentration of alkaloids calculated as hyoscyamine in the medicine and must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

759

BELLADONNA HERB POWDER

A,H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb powder.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropinei n the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

760

BELLADONNA HERB PREPARED

A,H

Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb prepared and must be declared in the application.

The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of atropine from all ingredients in the product must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

761

BELLIS PERENNIS

A,H

762

BEMOTRIZINOL

A

Only for use as an active ingredient in topical sunscreens for dermal application.

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

763

BENINCASA HISPIDA

A,E,H

764

BENTONITE

E

765

BENZALDEHYDE

E

766

BENZALDEHYDE GLYCERYL ACETAL

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%.

767

BENZALKONIUM CHLORIDE

E

Only for use in topical medicines for dermal application and nasal sprays.

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

768

BENZETHONIUM CHLORIDE

E

Only for use as a preservative in topical medicines for dermal application.

The medicine requires the warning statement:

- (BNZTHC) 'Contains Benzethonium chloride' (or words to that effect).

769

BENZOIC ACID

E,H

Medicines containing benzoates require the following warning statement on the medicine label:

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

770

BENZOIN

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%.

771

BENZOIN SIAM

A,E,H

772

BENZOIN SUMATRA

A,E,H

773

BENZOPHENONE

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%.

774

BENZYL ACETATE

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%.

775

BENZYL ACETONE

E

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

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

776

BENZYL ALCOHOL

E

The medicine requires the warning statement:

- (BNZALC) 'Contains benzyl alcohol [quantity]' (or words to that effect).

777

BENZYL BENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing benzoates require the warning statement:

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

778

BENZYL BUTYRATE

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%.

779

BENZYL CINNAMATE

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 0.15%.

780

BENZYL DIMETHYL CARBINYL-N-BUTYRATE

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%.

781

BENZYL FORMATE

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%.

782

BENZYL ISOAMYL ETHER

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%.

783

BENZYL 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%.

784

BENZYL ISOVALERATE

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%.

785

BENZYL LAURATE

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%.

786

BENZYL PHENYLACETATE

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%.

787

BENZYL PROPIONATE

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%.

788

BENZYL SALICYLATE

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%.

789

BENZYLIDENE ACETONE

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%.

790

BENZYLIDENE CAMPHOR SULFONIC ACID

A

Only for use as an active ingredient in sunscreens for dermal application.

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

791

BERBERIS AQUIFOLIUM

A,H

792

BERBERIS ARISTATA

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).

793

BERBERIS VULGARIS

A,E,H

794

BERGAMOT 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%.

795

BERGAMOT OIL BERGAPTEN-FREE

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%.

796

BERGAMOT OIL COLDPRESSED

A,E,H

When for internal use, Oxedrine is a mandatory component of bergamot oil coldpressed.

The maximum recommended daily dose must not provide more than 30 mg of Oxedrine.

The ingredient bergamot oil coldpressed is subject to the following conditions :

a) steam distilled or rectified;

b) in preparations for internal use;

c) in preparations containing 0.4 % or less of bergamot oil;

d) in soaps or bath and shower gels that are washed off the skin;

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

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

797

BERGAMOT OIL TERPENELESS

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%.

798

BERTHOLLETIA EXCELSA

A,E,H

799

BETA-CARYOPHYLLENE

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%.

800

BETA-DAMASCENONE

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%.

801

BETA-DAMASCONE

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%.

802

BETA-HOMO CYCLOCITRAL

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%.

803

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

804

BETA-IONONE

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%.

805

BETA-ISO-METHYL IONONE

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%.

806

BETA-METHYL NAPHTHYL KETONE

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%.

807

BETA-N-METHYL IONONE

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%.

808

BETA-NAPHTHOL ETHYLETHER

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%.

809

BETA-NAPHTHOL METHYL ETHER

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%.

810

BETA-NAPHTHYL ISOBUTYL ETHER

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%.

811

BETA-PINENE

E

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

812

BETA-TOCOPHEROL

E

813

BETA RAPA

A,E,H

814

BETA VULGARIS

A,E,H

815

BETA,4-DIMETHYLCYCLOHEX-3-ENE-1-PROPAN-1-AL

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%.

816

BETACAROTENE

A,E

817

BETADEX

E

818

BETAGLUCAN

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 0.01%.

819

BETAINE

E

Only for use in topical medicines for dermal application.

820

BETAINE HYDROCHLORIDE

E

821

BETULA LENTA

A,H

Methyl salicylate is a mandatory component of Betula lenta.

Only for use in topical medicines for dermal application.

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.

822

BETULA NIGRA

A,H

823

BETULA PENDULA

A,E,H

Methyl salicylate is a mandatory component of Betula pendula.

Only for use in topical medicines for dermal application.

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.

824

BETULA PUBESCENS

A,E,H

825

BICYCLO(2.2.1)HEPT-5-ENE-2-CARBOXYLIC ACID, 3-(1-METHYLETHYL)-, ETHYL ESTER, (1R,2R,3R,4S)-REL-

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%.

826

BICYCLO(2.2.2)OCT-5-ENE-2-CARBOXALDEHYDE, 6-METHYL-8-(1-METHYLETHYL)-

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%.

827

BIFIDOBACTERIUM ADOLESCENTIS

A

828

BIFIDOBACTERIUM ANIMALIS

A

829

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

830

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

831

BIFIDOBACTERIUM BIFIDUM

A

832

BIFIDOBACTERIUM BREVE

A

833

BIFIDOBACTERIUM INFANTIS

A

834

BIFIDOBACTERIUM LACTIS

A

835

BIFIDOBACTERIUM LONGUM

A

836

BILBERRY

E

837

BIOSACCHARIDE GUM-1

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 be no more than 5%.

838

BIOTA ORIENTALIS

A,H

839

BIOTIN

A,E

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

840

BIRCH LEAF DRY

A,E,H

841

BIRCH TAR OIL RECTIFIED

A,E,H

842

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

843

BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE

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 4%.

844

BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE

E

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

The concentration in the medicine must be no more than 2.5%.

845

BIS-PEG-12 DIMETHICONE BEESWAX

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 0.2%.

846

BIS-STEARYL ETHYLENEDIAMINE/NEOPENTYL GLYCOL/STEARYL HYDROGENATED DIMER DILINOLEATE COPOLYMER

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 7%.

847

BISABOLENE

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%.

848

BISABOLOL

E

If used as an excipient, the medicine is only for use in topical medicines for dermal application.

849

BITTER ALMOND 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%.

The absence of amygdalin in the medicine must be declared.

850

BIXA ORELLANA

A,E,H

851

BLACK COHOSH DRY

A,H

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

- (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.'

852

BLACK COHOSH POWDER

A,H

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

- (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.'

853

BLACK CURRANT

E

854

BLACK CURRANT 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%.

855

BLACK CURRANT FRESH

A,E,H

856

BLACK CURRANT SEED 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%.

857

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

858

BLACK PEPPER OIL

A,E,H

859

BLACK RASPBERRY

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%.

860

BLACKBERRY

E

861

BLACKBERRY OILS

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%.

862

BLACKBERRY WINE

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%.

863

BLACKCURRANT ESTERS

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%.

864

BLACKCURRANT JUICE

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%.

865

BLADDERWRACK DRY

A,H

Iodine is a mandatory component of Bladderwrack dry.

Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

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

866

BLADDERWRACK POWDER

A,H

Iodine is a mandatory component of Bladderwrack powder.

Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

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

867

BLAINVILLEA ACMELLA

A,H

868

BLETILLA STRIATA

A,H

869

BLUE FLAG RHIZOME DRY

A,H

870

BLUE FLAG RHIZOME POWDER

A,H

871

BLUEBERRY

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%.

872

BLUEBERRY JUICE

E

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

873

BLUMEA LACERA

A,H

874

BOEHMERIA NIVEA

A,H

875

BOERHAVIA DIFFUSA

A,H

876

BOERHAVIA REPENS

A,H

877

BOGBEAN LEAF DRY

A,H

878

BOGBEAN LEAF POWDER

A,H

879

BOIS DE ROSE OIL

A,E,H

880

BOMBAX CEIBA

A,H

881

BORAGO OFFICINALIS

A,E,H

882

BORAX

A,E,H

Boron is a mandatory component of Borax.

The percentage of Boron from Borax should be calculated based on the molecular weight of Borax.

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use.

883

BORAX PENTAHYDRATE

A,E

Boron is a mandatory component of Borax Pentahydrate.

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

The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use.

884

BORIC ACID

A,H

Boron is a mandatory component of Boric acid. The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid

The maximum recommended daily dose must provide no more than 6mg of Boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%

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

885

BORNEOL

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%.

886

BORNYL 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%.

887

BORON

H

Only for use as an active homoeopathic ingredient. 

When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron.

When for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.

888

BORON NITRIDE

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 0.5%.

889

BORONIA 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%.

890

BORONIA MEGASTIGMA

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%.

891

BOSWELLIA CARTERII

A,E,H

892

BOSWELLIA SERRATA

A,E,H

893

BOSWELLIA THURIFERA

A,H

894

BOTRYTIS CINEREA

A,H

895

BOVINE CALCIUM CHONDROITIN SULFATE

A

896

BOVINE POTASSIUM CHONDROITIN SULFATE

A

897

BOVINE WHEY IG-RICH FRACTION

A

Only for use in oral medicines.

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

- (COWMK) 'Derived from cows milk'

- (BABY3) 'Not suitable for use in children under the age of 12 months - except on the advice of a health professional)'.

898

BRANDY

E

899

BRASSICA CHINENSIS

A,H

Allyl isothiocyanate is a mandatory component of Brassica chinensis when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

900

BRASSICA JUNCEA

A,H

Allyl isothiocyanate is a mandatory component of Brassica juncea when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

901

BRASSICA NAPUS

A,E,H

Allyl isothiocyanate is a mandatory component of Brassica napus when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

902

BRASSICA NIGRA

A,H

Allyl isothiocyanate is a mandatory component of Brassica nigra when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

903

BRASSICA OLERACEA VAR. BOTRYTIS

A,E,H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. botrytis when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

904

BRASSICA OLERACEA VAR. CAPITATA

A,E,H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. capitata when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

905

BRASSICA OLERACEA VAR. GEMMIFERA

A,H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. gemmifera when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

906

BRASSICA OLERACEA VAR. ITALICA

A,H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var italica when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

907

BRASSICA OLERACEA VAR. VIRIDIS

A,H

Allyl isothiocyanate is a mandatory component of Brassica oleracea var. viridis when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

908

BRASSICA PEKINENSIS

A,H

Allyl isothiocyanate is a mandatory component of Brassica pekinensis when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

909

BRASSICA RAPA

A,E,H

Allyl isothiocyanate is a mandatory component of Brassica rapa when the plant part is seed.

The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate.

910

BRAZIL NUT

E

911

BRILLIANT BLACK BN

E

Permitted for use as a colour for oral and topical use.

912

BRILLIANT BLUE FCF

E

Permitted for use as a colour for oral and topical use.

913

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

Permitted for use as a colour for oral and topical use.

914

BRILLIANT BLUE FCF BARIUM LAKE

E

Permitted for use as a colour for oral and topical use.

915

BRILLIANT SCARLET 4R

E

Permitted for use as a colour for oral and topical use.

916

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

Permitted for use as a colour for oral and topical use.

917

BRIZA MEDIA

A,H

918

BROCCOLI

E

919

BROMELAINS

A

May be derived from either the stem or fruit of the pineapple (Ananas comosus).

If used in a divided preparation, the allowed units are papain units and million papain units.

If used in an undivided preparation, the allowed units are million papain units per gram.

920

BROMINE

H

Only for use as an active homoeopathic ingredient.

The concentration of bromine in the preparation must be no more than 14mg/Kg or 14mg/L or 0.0014% for oral and sublingual use.

921

BROMOSTYROL

E

Not for use in infants

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%.

922

BROMUS CATHARTICUS

A,H

923

BROMUS INERMIS

A,H

924

BROMUS RAMOSUS SUBSP. RAMOSUS

A,H

925

BRONOPOL

E

Only for use as an excipient in topical medicines for dermal application.

The medicine requires the warning statement:

- (BRONOP) 'Contains bronopol [quantity]' (or words to that effect).

926

BROUSSONETIA PAPYRIFERA

A,H

927

BROWN FK

E

Permitted for use as a colour for topical use.

928

BRUNFELSIA UNIFLORA

A,H

The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material.

929

BRUSSEL SPROUT

E

930

BRYONIA ALBA

A,H

931

BRYONIA DIOICA

A,H

932

BUCHU LEAF DRY

A,H

933

BUCHU LEAF 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%.

934

BUCHU LEAF POWDER

A,E,H

935

BUCKWHEAT

E,H

Only for use as an active homoeopathic or excipient ingredient.

936

BUDDLEJA OFFICINALIS

A,H

937

BULNESIA SARMIENTI

A,E,H

938

BUNIAS ORIENTALIS

A,H

939

BUPLEURUM FALCATUM

A,H

940

BURDOCK LEAF DRY

A,H

941

BURDOCK LEAF POWDER

A,H

942

BURDOCK ROOT DRY

A,H

943

BURDOCK ROOT POWDER

A,H

944

BUTAN-1-OL

E

The residual solvent limit for Butan-1-ol is 50 mg per maximum recommended daily dose.

The concentration in the medicine must be no more than 0.5%.

945

BUTANE

E

Only for use as an excipient propellant ingredient.

946

BUTOXYETHANOL

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%.

947

BUTTER

E

948

BUTTER ACIDS

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%.

949

BUTTER ESTERS

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%.

950

BUTTER STARTER DISTILLATE

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%.

951

BUTTERMILK - DRIED

E

952

BUTYL 2-METHYLBUTYRATE

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%.

953

BUTYL ACETATE

E

The residual solvent limit for Butyl acetate is 50 mg per maximum recommended daily dose.

The concentration in the medicine must be no more than 0.5%.

954

BUTYL BUTYRATE

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%.

955

BUTYL BUTYRYL LACTATE

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%.

956

BUTYL CAPROATE

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%.

957

BUTYL ESTER OF PVM/MA COPOLYMER

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 15%.

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

- (EYE) 'Avoid contact with eyes' (or words to that effect)

- (EYE2) 'May be irritant to the eyes' (or words to that effect).

958

BUTYL FORMATE

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%.

959

BUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

Medicines containing hydroxybenzoates require the following warning statement on the medicine label:

- (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.

960

BUTYL ISOBUTYRATE

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%.

961

BUTYL ISOVALERATE

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%.

962

BUTYL LACTATE

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%.

963

BUTYL LEVULINATE

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%.

964

BUTYL METHOXYDIBENZOYLMETHANE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in preparation must be no more than 5%.

965

BUTYL PROPIONATE

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%.

966

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

967

BUTYL UNDECYLENATE

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%.

968

BUTYLATED HYDROXYANISOLE

E

The medicine requires the warning statement:

- (BHANIS) 'Contains butylated hydroxyanisole' (or words to that effect).

969

BUTYLATED HYDROXYTOLUENE

E

970

BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE

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%.

971

BUTYLENE/ETHYLENE/STYRENE COPOLYMER - HYDROGENATED

E

Only for use in topical medicines for dermal application. 

The combined concentration of Butylene/ethylene/stryene copolymer - hydrogenated and ethylene/propylene/styrene copolymer - hydrogenated in the medicine must be no more than 9%.

972

BUTYLIDENE PHTHALIDE

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%.

973

BUTYLOCTYL SALICYLATE

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 7%.

974

BUTYLPHENYL METHYLPROPIONAL

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%.

975

BUTYRALDEHYDE

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%.

976

BUTYRIC ACID

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%.

977

C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE

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 0.012%.

978

C10-12 ALKANE/CYCLOALKANE

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%.

979

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

980

C11-14-ISO-ALCOHOL C-13 RICH

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%.

981

C12-13 PARETH-23

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 0.125%.

Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection.

982

C12-15 ALKYL LACTATE

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 1.2%.

983

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

984

C12-20 ACID PEG-8 ESTER

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 0.2%.

985

C12-20 ALKYL GLUCOSIDE

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 0.75%.

986

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

987

C14-22 ALCOHOLS

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 2.55%.

988

C15-19 ALKANE

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 7%.

989

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

990

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

991

C2-OCTENAL

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%.

992

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

993

C20-40 ALKYL STEARATE

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 2%.

994

C20-40 PARETH-24

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 0.25%.

995

C20-40 PARETH-3

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 2%.

996

C30-45 ALKYL CETEARYL DIMETICONE CROSSPOLYMER

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 1%.

997

C6-14 OLEFIN POLYMERS - HYDROGENATED

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 7%.

998

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

999

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

1000

C9-15 ALKYL PHOSPHATE

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 0.12%

1001

CABBAGE

E

1002

CABREUVA OIL

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%.

1003

CADE OIL

A,E,H

1004

CAESALPINIA SAPPAN

A,H

1005

CAFFEINE

A,E

When used as an excipient, only for use in topical medicines for dermal application.

Only for use as an active ingredient for oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations 1990 (other than caffeine); and contains no more than 100 mg of caffeine per maximum daily dose.

Medicines for oral use containing caffeine as an active ingredient require the following warning statement on the medicine label:

- (ADULT) 'Adults only' (or words to that effect).

When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of:

a)  more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label:

- (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.'

b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label:

- (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'.

1006

CAJUPUT OIL

A,E,H

Cineole is a mandatory component of Cajuput oil.

When the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL.

When the concentration in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container.

When the concentration in the medicine is more than 25% and the nominal capacity of the container is less than 15 mL, a restricted flow insert must be fitted to the container.

When the concentration in the medicine is more than 25%, the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'.

1007

CALAMINE

A,E

Only for use as an active or excipient ingredient 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 Pharmacopeia.

1008

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

1009

CALCIUM AMINO ACID CHELATE

A,E,H

May only be used as a source of calcium.

Calcium is a mandatory component of Calcium amino acid chelate.

The concentration of Calcium in the medicine must be no more than 25% of the Calcium amino acid chelate in the formulation.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1010

CALCIUM ASCORBATE

A,E,H

Based on molecular weights the accepted percentage of Calcium from Calcium ascorbate is 10.3%. The declared quantity of Calcium from Calcium ascorbate must be no less than 9.8% and must be no more than 10.8% of the Calcium ascorbate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

Based on molecular weights the accepted percentage of Ascorbic acid from Calcium ascorbate is 90.3%. The declared quantity of Ascorbic acid from Calcium ascorbate must be no less than 84.9% and must be no more than 95.3% of the Calcium ascorbate in the medicine. These figures incorporate a 5% variance to allow for rounding in calculations. 

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1011

CALCIUM ASCORBATE DIHYDRATE

A,E,H

Based on molecular weights the accepted percentage of Ascorbic acid from Calcium ascorbate dihydrate is 82.7%.  The declared quantity of Ascorbic acid from Calcium ascorbate dihydrate must be no less than 77.8% and must be no more than 87.2% of the Calcium ascorbate dihydrate in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.

Based on molecular weights the accepted percentage of Calcium from Calcium ascorbate dihdrate is 9.4%.  The declared quantity of Calcium from Calcium ascorbate dihydrate must be no less than 8.9% and must be no more than  9.9% of the Calcium ascorbate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1012

CALCIUM ASPARTATE

A

Calcium is a mandatory component of Calcium aspartate and availability is restricted to use as a source of the relevant mineral only.

The percentage of calcium from calcium aspartate should be calculated based on the molecular weight of calcium aspartate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1013

CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE

A

Only for use as an active ingredient in oral medicines.

Calcium is a mandatory component of Calcium aspartate hydrochloride dihydrate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from calcium aspartate hydrochloride dihydrate should be calculated based on the molecular weight of calcium aspartate hydrochloride dihydrate.

The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1014

CALCIUM BEHENATE

E

Behenic acid is a mandatory component of Calcium behenate.

When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 mg of Behenic acid.

1015

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE

A,H

The declared quantity of Calcium from Calcium beta-hydroxy-beta-methylbutryate must be no less than 13.9% and must be no more than 15.3% of the Calcium beta-hydroxy-beta-methylbutryate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. 

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

1016

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A,H

The declared quantity of Calcium from Calcium beta-hydroxy-beta-methylbutryate monohydrate must be no less than 13.07% and must be no more than 14.45% of the Calciumbeta-hydroxy-beta-methylbutryate monohydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. 

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

1017

CALCIUM CARBONATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium carbonate.

The percentage of calcium from calcium carbonate should be calculated based on the molecular weight of calcium carbonate.

The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1018

CALCIUM CASEINATE

E

1019

CALCIUM CHLORIDE DIHYDRATE

E

1020

CALCIUM CITRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium citrate.

The percentage of calcium from calcium citrate should be calculated based on the molecular weight of calcium citrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead toosteoporosis in later life.’

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

1021

CALCIUM CITRATE TETRAHYDRATE

A,E,H

If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium citrate tetrahydrate.

The amount of calcium in the active ingredient should be calculated based on the molecular weight of calcium citrate tetrahydrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1022

CALCIUM DIASPARTATE

A

Only for use as active ingredient in oral medicines. Calcium is a mandatory component of Calcium diaspartate and availability is restricted to use as a source of the relevant mineral only.

The percentage of calcium from calcium diaspartate should be calculated based on the molecular weight of calcium diaspartate.

The following indications are only permitted when the medicine is for oral and sublingual use:- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1023

CALCIUM FLUORIDE

H

Based on molecular weights the accepted percentage of Fluoride from Calcium fluoride is 48.7%.  The declared quantity of fluoride from Calcium fluoride must be no less than 46.3% and must be no more than 51.1% of the Calcium fluoride in the formulation.  These figures incorporate a 5% variance to allow for rounding in calculations.

In medicines for dental use, when containing more than 1000 mg/kg or 1000 mg/L and less than 1500 mg/kg or 1500mg/L of fluoride ion, the product label must comply with the requirements of the 'Required Advisory Statements for Medicine Labels' (RASML). The concentration of fluoride in the product from all ingredients must be no more than 15 mg/kg or 15 mg/L or 0.15%.

In products other than dental products, the concentration of fluoride in the product from all ingredients must be no more than 15 mg/kg or 15 mg/L or 0.15%.

The medicine requires the following statements on the medicine label:

- 'Do not swallow'

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

1024

CALCIUM FOLINATE

A,E,H

Folinic acid is a mandatory component of Calcium folinate.

The maximum daily dose must provide less than 500 micrograms of folinic acid.

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

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:

- (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’

1025

CALCIUM GLUCONATE MONOHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium gluconate monohydrate.

The percentage of calcium from calcium gluconate monohydrate should be calculated based on the molecular weight of calcium gluconate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1026

CALCIUM GLYCEROPHOSPHATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium glycerophosphate.

The percentage of calcium from calcium glycerophosphate should be calculated based on the molecular weight of calcium glycerophosphate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1027

CALCIUM GLYCINATE

A

Only for use as active ingredient in oral medicines.

Calcium is a mandatory component of Calcium glycinate and availability is restricted to use as a source of the relevant mineral only.

Based on molecular weights the declared quantity of Calcium from Calcium glycinate must be no less than 20.24% and no more than 22.37% of the Calcium glycinate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1028

CALCIUM GLYCINATE DIHYDRATE

A

Calcium is a mandatory component of Calcium glycinate dihydrate and availability is restricted to use as a source of the relevant mineral only.

Based on molecular weights the declared quantity of Calcium from Calcium glycinate dihydrate must be no less than 17% and must be no more than 18.8% of the Calcium glycinate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1029

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

1030

CALCIUM HYDROGEN PHOSPHATE

A,E,H

Calcium is a mandatory component of calcium hydrogen phosphate.

If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium hydrogen phosphate.

The percentage of calcium from calcium hydrogen phosphate should be calculated based on the molecular weight of calcium hydrogen phosphate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1031

CALCIUM HYDROGEN PHOSPHATE DIHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium hydrogen phosphate dihydrate.

The percentage of calcium from calcium hydrogen phosphate dihydrate should be calculated based on the molecular weight of calcium hydrogen phosphate dihydrate.

The following indications are only permitted when the medicine is for oral and sublingual use: (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1032

CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydrogen phosphate monohydrate.

The percentage of calcium from Calcium Hydrogen Phosphate Monohydrate should be calculated based on the molecular weight of Calcium Hydrogen Phosphate Monohydrate. The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1033

CALCIUM HYDROXIDE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydroxide. The percentage of calcium from calcium hydroxide should be calculated based on the molecular weight of calcium hydroxide.

When used as a standard active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopeia.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.'

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

1034

CALCIUM HYDROXYCITRATE

A,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydroxycitrate. The percentage of calcium from calcium hydroxycitrate should be calculated based on the molecular weight of Calcium hydroxycitrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1035

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

1036

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

1037

CALCIUM KETOGLUCONATE

E

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

The concentration must be no more than 1%

1038

CALCIUM L-THREONATE

A

Only for oral use.

Calcium is a mandatory component of Calcium L-threonate.

The percentage of calcium from calcium L-threonate should be calculated based on the molecular weight of calcium L-threonate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1039

CALCIUM LACTATE

A,E,H

If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium lactate.

The percentage of calcium from calcium lactate should be calculated based on the molecular weight of calcium lactate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1040

CALCIUM LACTATE GLUCONATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate gluconate.

The percentage of calcium from Calcium lactate gluconate should be calculated based on the molecular weight of Calcium lactate gluconate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1041

CALCIUM LACTATE PENTAHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate pentahydrate.

The percentage of calcium from Calcium Lactate Pentahydrate should be calculated based on the molecular weight of Calcium Lactate Pentahydrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1042

CALCIUM LACTATE TRIHYDRATE

A,E,H

If used as an active ingredient and the preparation is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate trihydrate.

The percentage of calcium from Calcium Lactate Trihydrate should be calculated based on the molecular weight of Calcium Lactate Trihydrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1043

CALCIUM LYSINATE

A

Only for use as active ingredient in oral medicines.

Calcium is a mandatory component of Calcium lysinate and availability is restricted to use as a source of the relevant mineral only.

The percentage of calcium from Calcium Lysinate should be calculated based on the molecular weight of Calcium Lysinate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1044

CALCIUM METHIONINATE

A

Only for use as active ingredient in oral medicines.

Calcium is a mandatory component of Calcium methioninate and availability is restricted to use as a source of the relevant mineral only.

Based on molecular weights the declared quantity of Calcium from Calcium methioninate must be no less than 11.32% and must be no more than 12.51% of the Calcium methioninate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1045

CALCIUM OROTATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium orotate.

The percentage of calcium from Calcium Orotate should be calculated based on the molecular weight of Calcium Orotate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1046

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

1047

CALCIUM PANTOTHENATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium pantothenate.

The percentage of calcium from Calcium Pantothenate should be calculated based on the molecular weight of Calcium Pantothenate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

The following indications are only permitted when the medicine is for oral and sublingual use:

1048

CALCIUM PHOSPHATE

A,E,H

When used as an active ingredient and the preparation is intended as a mineral supplementation, calcium is mandatory component of Calcium phosphate.

The percentage of calcium from Calcium Phosphate should be calculated based on the molecular weight of Calcium Phosphate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1049

CALCIUM PHOSPHATE - MONOBASIC

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium phosphate - monobasic.

The percentage of calcium from calcium phosphate - monobasic should be calculated based on the molecular weight of calcium phosphate - monobasic.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1050

CALCIUM PYRUVATE

A

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium pyruvate.

The percentage of calcium from calcium pyruvate should be calculated based on the molecular weight of calcium pyruvate.

The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1051

CALCIUM SACCHARATE

E

1052

CALCIUM SILICATE

E

1053

CALCIUM SODIUM CASEINATE

A,H

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

 - (COWMK) 'Derived from cow's milk'.

1054

CALCIUM SODIUM LACTATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sodium lactate.

The percentage of calcium from calcium sodium lactate should be calculated based on the molecular weight of calcium sodium lactate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1055

CALCIUM STEARATE

E

1056

CALCIUM SUCCINATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium succinate.

The percentage of calcium from calcium succinate should be calculated based on the molecular weight of calcium succinate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1057

CALCIUM SULFATE

A,E,H

If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sulfate.

The amount of calcium in the active ingredient should be calculated based on the molecular weight of calcium sulfate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1058

CALCIUM SULFATE - DRIED

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sulfate - dried.

The percentage of calcium from calcium sulfate - dried should be calculated based on the molecular weight of calcium sulfate - dried.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1059

CALCIUM SULFATE DIHYDRATE

A,E,H

When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sulfate dihydrate. The percentage of calcium from calcium sulfate dihydrate should be calculated based on the molecular weight of calcium sulfate dihydrate.

The following indications are only permitted when the medicine is for oral and sublingual use:

- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1060

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

1061

CALCIUM THREONINATE

A

Only for use as an active ingredient.

Calcium is a mandatory component of Calcium threoninate and availability is restricted to use as a source of the relevant mineral only.

The percentage of calcium from Calcium Threonite should be calculated based on the molecular weight of Calcium Threonite.

The following indications are only permitted when the medicine is for oral and sublingual use - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’

- (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’

- (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’

- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’

- (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’

- (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’

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

1062

CALENDULA FLOWER DRY

A,E,H

1063

CALENDULA FLOWER POWDER

A,H

1064

CALENDULA OFFICINALIS

A,E,H

1065

CALLERYA RETICULATA

A,H

1066

CALLICARPA PEDUNCULATA

A,H

1067

CALLISTEMON CITRINUS

A,H

1068

CALLISTEPHUS CHINENSIS

A,H

1069

CALLITRIS INTRATROPICA

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%.

1070

CALLITRIS RHOMBOIDEA

A,H

1071

CALLUNA VULGARIS

A,E,H

1072

CALOCHORTUS TOLMIEI

A,H

1073

CALTHA PALUSTRIS

A,H

1074

CALUMBA ROOT DRY

A,H

1075

CALUMBA ROOT POWDER

A,H

1076

CALVATIA GIGANTEA

A,E,H

1077

CALYCANTHUS FLORIDUS

A,H

1078

CALYCANTHUS PRAECOX

A,H

1079

CAMELLIA JAPONICA

A,H

1080

CAMELLIA OLEIFERA

A,E,H

If Camellia oleifera (seed oil) is used as a solvent, it is restricted to topical or sunscreen preparations for dermal application only.

1081

CAMELLIA SINENSIS

A,E,H

Caffeine is a mandatory component of Camellia sinensis for oral use.

Medicines for oral or sublingual administration that contain caffeine as a component of a herbal substance and that provide a maximum recommended daily dose of:

a) more than 1 mg but no more than 10 mg of caffeine require the following warning statement on the medicine label:

- (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.'

b) more than 10 mg of caffeine require the following warning statement on the medicine label:

- (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product].'

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

1082

CAMPHENE

E

Permitted for use only in combination with other permitted ingredients as a coating solution, 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%.

1083

CAMPHOR

E,H

In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%.

In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%.

In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children (or word to that effect)'

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more less than 15 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children (or word to that effect)'

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children (or word to that effect)'

- (NTAKEN) 'Not to be taken'

1084

CAMPHOR BENZALKONIUM METHOSULFATE

A

Only for use as an active ingredient in sunscreens for dermal application.

The concentration in the preparation must be no more than 6%.

1085

CAMPHOR OIL BROWN

A,H

Camphor, cineole and safrole are mandatory components of Camphor oil brown.

In solid and semi solid preparations, the concentration of Camphor must be no more than 12.5%.

In liquid preparations other than essential oils, the concentration of Camphor must be no more than 2.5%.

In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more less than 15 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

1086

CAMPHOR OIL WHITE

A,E,H

Camphor and safrole are mandatory components of Camphor oil white.

In solid and semi solid preparations, the concentration of Camphor must be no more than 12.5%.

In liquid preparations other than essential oils, the concentration of Camphor must be no more than 2.5%.

In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more less than 15 mL, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 mL but less than or equal to 25 mL, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label:

- (CHILD) 'Keep out of reach of children' (or word to that effect)

- (NTAKEN) 'Not to be taken'

When for internal use then the concentration of safrole in the medicine must be no more than 0.1%.

When for topical use then the concentration of safrole in the medicine must be no more than 1%.

1087

CAMPSIS GRANDIFLORA

A,H

1088

CANADA BALSAM

A,H

1089

CANANGA ODORATA

A,E,H

1090

CANANGA OIL

A,E,H

1091

CANARIUM INDICUM

A,H

The plant part must be seed and the plant preparation is oil.

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

- (DERIVED) 'This product contains material derived from nuts' (or words to that effect).

1092

CANARIUM LUZONICUM

A,H

1093

CANDELILLA WAX

A,E,H

1094

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

1095

CANDIDA UTILIS

A,H

1096

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

1097

CANOLA OIL

A,E,H

Allyl isothiocyanate is a mandatory component of Canola oil.

The maximum recommended daily dose must not provide more than 20 mg of Allyl isothiocyanate.

1098

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

1099

CANTHAXANTHIN

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1100

CAPRIC ACID

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%.

1101

CAPROIC ALDEHYDE

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%.

1102

CAPRYLIC ALDEHYDE

E

Permitted for use only in combination with other permitted ingredients as a coating solution, 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%.

1103

CAPRYLIC/CAPRIC GLYCERIDES

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%.

1104

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

1105

CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE

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 is not to exceed 3%

1106

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1107

CAPRYLOYL GLYCINE

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 not be more than 2%

1108

CAPRYLOYL SALICYLIC ACID

E

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

The concentration in the medicine must not be more than 0.3%.

1109

CAPRYLYL GLYCOL

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 2%

1110

CAPRYLYL METHICONE

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%.

1111

CAPSELLA BURSA-PASTORIS

A,H

1112

CAPSICUM

E,H

Only for use as an active homoeopathic or excipient ingredient.

1113

CAPSICUM ANNUUM

A,E,H

1114

CAPSICUM DRY

A,E,H

1115

CAPSICUM FRUIT OLEORESIN

A,E

1116

CAPSICUM FRUTESCENS

A,E,H

1117

CAPSICUM POWDER

A,E,H

1118

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

The plant part must be herb and the plant preparation must be a hydroethanolic extract.

1119

CARAMEL

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1120

CARAPICHEA IPECACUANHA

A,H

Emetine is a mandatory component of Carapichea ipecacuanha.

The concentration of emetine in the medicine must be no more than 0.2%.

Except when used in a medicine containing only homoeopathic preparations, a child resistant closure must be fitted onto the container.

1121

CARAWAY DRY

A,H

1122

CARAWAY OIL

A,E,H

1123

CARAWAY POWDER

A,H

1124

CARBOMER - SODIUM

E

Only for use as an excipient in topical medicines for dermal application.

1125

CARBOMER 1342

E

Only for use as an excipient in topical medicines for dermal application.

1126

CARBOMER 2001

E

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

The concentration must be no more than 1% in formulations at pH 7 (approximately neutral) and 0.1% in formulations at a different pH.

1127

CARBOMER 934

E

Only for use in topical medicines for dermal application.

1128

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

1129

CARBOMER 940

E

Only for use in topical medicines for dermal application.

1130

CARBOMER 941

E

Only for use as an excipient in topical medicines for dermal application.

1131

CARBOMER 954

E

Only for use as an excipient in topical medicines for dermal application.

1132

CARBOMER 980

E

Only for use as an excipient in topical medicines for dermal application.

1133

CARBOMER 981

E

Only for use as an excipient in topical medicines for dermal application.

1134

CARBOMER COPOLYMER (TYPE B)

E

Only for use as an excipient in topical medicines for dermal application.

1135

CARBOMER HOMOPOLYMER (TYPE B)

E

Only for use as an excipient in topical medicines for dermal application.

1136

CARBOMER U-10

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 5%.

1137

CARBON

E,H

Only for use as an active homoeopathic or excipient ingredient.

1138

CARBON BLACK

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1139

CARBON DIOXIDE

E

1140

CARDAMOM FRUIT DRY

A,H

1141

CARDAMOM FRUIT POWDER

A,E,H

1142

CARDAMOM OIL

A,E,H

1143

CARDIOSPERMUM HALICACABUM

A,H

1144

CARICA PAPAYA

A,E,H

1145

CARLINA ACAULIS

A,H

1146

CARMELLOSE

E

1147

CARMELLOSE CALCIUM

E

1148

CARMELLOSE SODIUM

E

1149

CARMINE

E

Permitted for use as a colour for oral and topical use.

1150

CARMOISINE

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1151

CARMOISINE ALUMINIUM LAKE

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1152

CARNAUBA WAX

A,E,H

1153

CARNOSINE

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 0.2%.

1154

CAROB BEAN 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%.

1155

CAROB GUM

E

1156

CAROB POD

E

1157

CAROTENES

E

Permitted as an excipient ingredient as a colour for oral and topical use.

1158

CARPINUS BETULUS

A,H

1159

CARPINUS CORDATA

A,H

1160

CARRAGEENAN

E

1161

CARROT

E

1162

CARROT SEED OIL

A,E,H

1163

CARTHAMUS TINCTORIUS

A,E,H

Carthamus tinctorius (sunflower oil) when used as a solvent is restricted to topical or sunscreen preparations for dermal application only.

If for oral use, the medicine requires the following warning statement on the medicine label:

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

1164

CARUM CARVI

A,H

1165

CARVACROL

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%.

1166

CARVACRYL METHYL ETHER

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%.

1167

CARVEOL

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%.

1168

CARVONE

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%.

1169

CARVYL ACETATE

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%.

1170

CARYA ILLINOINENSIS

A,H

1171

CARYA OVATA

A,H

1172

CARYOPHYLLENE OXIDE

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%.

1173

CASCARA DRY

A,H

Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Cascara dry when the route of administration is oral.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect)

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect)

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’

- (LAX4) ‘This product may have laxative effect’

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX1) ‘Drink plenty of water' (or words to that effect)

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

1174

CASCARA POWDER

A,H

Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Cascara powder when the route of administration is oral administration.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect)

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect)

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’

- (LAX4) ‘This product may have laxative effect’

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX1) ‘Drink plenty of water' (or words to that effect)

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

1175

CASCARILLA OIL

A,H

The medicine must not contain more than 1mg of the equivalent dry herbal material per the maximum recommended daily dose.

1176

CASEIN

E

1177

CASHEW NUT

E

1178

CASSIA ALATA LEAF EXTRACT

E

Only for use as an excipient ingredient in sunscreens for dermal application and not to be intended for use in the eye. 

The extraction ratio of the Cassia alata can only be 1:3 in 62.5% glycerine:water.

The concentration in the medicine must be no more than 0.0275%.

1179

CASSIA CINNAMON BARK DRY

A,H

When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin.

1180

CASSIA CINNAMON BARK POWDER

A,H

When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin.

1181

CASSIA FISTULA

A,H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula when the route of administration is oral.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect)

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water' (or words to that effect)

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’

- (LAX4) ‘This product may have laxative effect’

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX1) ‘Drink plenty of water' (or words to that effect)

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect).

1182

CASSIA OCCIDENTALIS

A,H

Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia occidentalis when the route of administration is oral administration.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]’

- (S) ‘If symptoms persist consult your healthcare practitioner [or words to that effect]’.

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) ‘Drink plenty of water [or words to that effect]

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’

- (LAX4) ‘This product may have laxative effect’

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine the following warning statements on the medicine label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

- (LAX1) ‘Drink plenty of water [or words to that effect]’

- (LAX2) ‘Prolonged use may cause serious bowel problems’

- (S) ‘If symptoms persist consult your healthcare practitioner [or words to that effect]’

1183

CASSIA OIL

A,E,H

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

1184

CASSIE ABSOLUTE

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%.

1185

CASTANEA MOLLISSIMA

A,H

1186

CASTANEA SATIVA

A,H

1187

CASTOR OIL

A,E

1188

CASTOR OIL - ETHOXYLATED HYDROGENATED

E

1189

CASTOR OIL - HYDROGENATED

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 Pharmacopeia.

1190

CASTOR OIL - SULFATED

E

Only for use in topical medicines for dermal application.

1191

CASTOREUM

H

Only permitted for use as an active homoeopathic ingredient.

1192

CASUARINA EQUISITIFOLIA

A,H

1193

CATALPA BIGNONIOIDES

A,H

1194

CATALPA OVATA

A,H

1195

CATECHU

A,H

1196

CATHARANTHUS ROSEUS

A,H

Vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine are mandatory components of Cantharanthus roseus.

The concentration of vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

1197

CAULIFLOWER

E

1198

CAULOPHYLLUM THALICTROIDES

A,E,H

1199

CAUSTICUM

H

Only for use as an active homoeopathic ingredient.

1200

CEANOTHUS AMERICANUS

A,H

1201

CEDAR LEAF OIL

A,E,H

1202

CEDARWOOD 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%.

1203

CEDARWOOD OIL ATLAS

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%.

1204

CEDARWOOD OIL TERPENES

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%.

1205