724

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).

725

BACOPA MONNIERI

A, H

726

BALLOTA NIGRA

A, H

727

BALM OF GILEAD BUD DRY

A, H

728

BALM OF GILEAD BUD POWDER

A, H

729

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%.

730

BAMBUSA BREVIFLORA

A, E, H

731

BAMBUSA TEXTILIS

A, H

732

BANANA

E

733

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%.

734

BAPHICACANTHUS CUSIA

A, H

735

BAPTISIA CONFUSA

A, H

736

BAPTISIA TINCTORIA

A, H

737

BARBAREA VULGARIS

A, H

738

BARIUM CARBONATE

H

Only for use as an active homoeopathic ingredient.

739

BARIUM CHLORIDE

H

Only for use as an active homoeopathic ingredient.

740

BARIUM SULFATE

E

Only for use in topical medicines for dermal application.

741

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.

742

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.

743

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.

744

BARLEY LEAF

E

745

BASIC BUTYLATED METHACRYLATE COPOLYMER

E

Only for use in oral medicines.

746

BASIC FUCHSIN

E

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

747

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%.

748

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%.

749

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).

750

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).

751

BASSIA SCOPARIA

A, H

752

BATYL ALCOHOL

E

Only for use in topical medicines for dermal application.

753

BAY LEAF

E

754

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'

755

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%.

756

BEET RED

E

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

757

BEETROOT

E, H

758

BEGONIA FIMBRISTIPULA

A, H

759

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.

760

BEHENIC ACID

E

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

761

BEHENOXY DIMETHICONE

E

Only for use in topical medicines for dermal application.

762

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%.

763

BEHENYL ALCOHOL

E

Only for use in topical medicines for dermal application.

764

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%.

765

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%.

766

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%.

767

BELLIS PERENNIS

A, H

768

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%.

769

BENINCASA HISPIDA

A, E, H

770

BENTONITE

E

771

BENZALDEHYDE

E

772

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%.

773

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%.

774

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).

775

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.

776

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%.

777

BENZOIN SIAM

A, E, H

778

BENZOIN SUMATRA

A, E, H

779

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%.

780

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%.

781

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%.

782

BENZYL ALCOHOL

E

The medicine requires the warning statement:

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

783

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.

784

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%.

785

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%.

786

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%.

787

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%.

788

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%.

789

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%.

790

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%.

791

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%.

792

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%.

793

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%.

794

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%.

795

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%.

796

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).

797

BERBERIS AQUIFOLIUM

A, H

798

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).

799

BERBERIS VULGARIS

A, E, H

800

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%.

801

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%.

802

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 provide no more than 30 milligrams of oxedrine.

The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is:

a) for internal use; or

b) in preparations containing 0.4 per cent or less of bergamot oil coldpressed; or

c) for use in soaps or bath or shower gels that are washed off the skin.

803

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%.

804

BERTHOLLETIA EXCELSA

A, E, H

805

BETA RAPA

A, E, H

806

BETA VULGARIS

A, E, H

807

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%.

808

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%.

809

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%.

810

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%.

811

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%.

812

BETA-HYDROXY-BETA-METHYLBUTYRIC ACID

A

813

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%.

814

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%.

815

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%.

816

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%.

817

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%.

818

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%.

819

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%.

820

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%.

821

BETA-TOCOPHEROL

E

822

BETACAROTENE

A, E

When Vitamin A is declared as an equivalent of Betacarotene and the medicine is for oral or sublingual use in adults the medicine requires the following warning statements on the medicine label:

- (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’

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

823

BETADEX

E

824

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%.

825

BETAINE

E

Only for use in topical medicines for dermal application.

826

BETAINE HYDROCHLORIDE

E

827

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.

828

BETULA NIGRA

A, H

829

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.

830

BETULA PUBESCENS

A, E, H

831

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%.

832

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%.

833

BIFIDOBACTERIUM ADOLESCENTIS

A

834

BIFIDOBACTERIUM ANIMALIS

A

835

BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS

A

836

BIFIDOBACTERIUM ANIMALIS SSP LACTIS

A

837

BIFIDOBACTERIUM BIFIDUM

A

838

BIFIDOBACTERIUM BREVE

A

839

BIFIDOBACTERIUM INFANTIS

A

840

BIFIDOBACTERIUM LACTIS

A

841

BIFIDOBACTERIUM LONGUM

A

842

BILBERRY

E

843

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%.

844

BIOTA ORIENTALIS

A, H

845

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.’

846

BIRCH LEAF DRY

A, E, H

847

BIRCH TAR OIL RECTIFIED

A, E, H

848

BIS-DIGLYCERYL POLYACYLADIPATE-2

E

Only for use in topical medicines for dermal application.

849

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%.

850

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%.

851

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%.

852

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%.

853

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%.

854

BISABOLOL

E

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

855

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.

856

BIXA ORELLANA

A, E, H

857

BLACK BONED CHICKEN POWDER

A

858

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.'

859

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.'

860

BLACK CURRANT

E

861

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%.

862

BLACK CURRANT FRESH

A, E, H

863

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%.

864

BLACK OF CURACAO SPIDER

H

Only for use as an active homoeopathic ingredient.

865

BLACK PEPPER OIL

A, E, H

866

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%.

867

BLACK SNAKE

H

Only for use as an active homoeopathic ingredient.

868

BLACKBERRY

E

869

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%.

870

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%.

871

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%.

872

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%.

873

BLACKSTRAP MOLASSES

E

When for oral or sublingual use, Sucrose is a mandatory component of Molasses - blackstrap.

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

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

874

BLADDERWRACK DRY

A, H

Iodine is a mandatory component of Bladderwrack dry.

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

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.

875

BLADDERWRACK POWDER

A, H

Iodine is a mandatory component of Bladderwrack powder.

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

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.

876

BLAINVILLEA ACMELLA

A, E, H

When used as an excipient, 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%.

877

BLETILLA STRIATA

A, H

878

BLUE FLAG RHIZOME DRY

A, H

879

BLUE FLAG RHIZOME POWDER

A, H

880

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%.

881

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%.

882

BLUMEA LACERA

A, H

883

BOEHMERIA NIVEA

A, H

884

BOERHAVIA DIFFUSA

A, H

885

BOERHAVIA REPENS

A, H

886

BOGBEAN LEAF DRY

A, H

887

BOGBEAN LEAF POWDER

A, H

888

BOIS DE ROSE OIL

A, E, H

889

BOMBAX CEIBA

A, H

890

BORAGO OFFICINALIS

A, E, H

Only for use when the preparation is 'fixed oil' and the fixed oil is derived from seeds of Borago officinalis.

891

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.

892

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.

893

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.

894

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%.

895

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%.

896

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%.

897

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%.

898

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%.

899

BOSWELLIA CARTERII

A, E, H

900

BOSWELLIA SERRATA

A, E, H

901

BOSWELLIA THURIFERA

A, H

902

BOTRYTIS CINEREA

A, H

903

BOVINE CALCIUM CHONDROITIN SULFATE

A

904

BOVINE CHONDROITIN SULFATE

A

905

BOVINE COLOSTRUM POWDER

A

The medicine requires the warning statement:

- (BOVCOL) 'Products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect). This product is not suitable for use in children under the age of 12 months except on professional health advice.'

906

BOVINE LACTOFERRIN

A

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

- (COWMK) 'Derived from cow's milk.'

907

BOVINE POTASSIUM CHONDROITIN SULFATE

A

908

BOVINE SODIUM CHONDROITIN SULFATE

A

909

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)'.

910

BRANDY

E

911

BRASSICA CHINENSIS

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

912

BRASSICA JUNCEA

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

913

BRASSICA NAPUS

A, E, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

914

BRASSICA NIGRA

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

915

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 concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

916

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 concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

917

BRASSICA OLERACEA VAR. GEMMIFERA

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

918

BRASSICA OLERACEA VAR. ITALICA

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

919

BRASSICA OLERACEA VAR. VIRIDIS

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

920

BRASSICA PEKINENSIS

A, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

921

BRASSICA RAPA

A, E, H

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

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

922

BRAZIL NUT

E

923

BRILLIANT BLACK BN

E

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

924

BRILLIANT BLUE FCF

E

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

925

BRILLIANT BLUE FCF ALUMINIUM LAKE

E

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

926

BRILLIANT BLUE FCF BARIUM LAKE

E

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

927

BRILLIANT SCARLET 4R

E

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

928

BRILLIANT SCARLET 4R ALUMINIUM LAKE

E

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

929

BRIZA MEDIA

A, H

930

BROCCOLI

E

931

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.

932

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.

933

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%.

934

BROMUS CATHARTICUS

A, H

935

BROMUS INERMIS

A, H

936

BROMUS RAMOSUS SUBSP. RAMOSUS

A, H

937

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).

938

BROUSSONETIA PAPYRIFERA

A, H

939

BROWN FK

E

Permitted for use only as a colour for topical use.

940

BRUNFELSIA UNIFLORA

A, H

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

941

BRUSSEL SPROUT

E

942

BRYONIA ALBA

A, H

943

BRYONIA DIOICA

A, H

944

BUCHU LEAF DRY

A, H

945

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%.

946

BUCHU LEAF POWDER

A, E, H

947

BUCKWHEAT

E, H

Only for use as an active homoeopathic or excipient ingredient.

948

BUDDLEJA OFFICINALIS

A, H

949

BULNESIA SARMIENTI

A, E, H

950

BUNIAS ORIENTALIS

A, H

951

BUPLEURUM FALCATUM

A, H

952

BURDOCK LEAF DRY

A, H

953

BURDOCK LEAF POWDER

A, H

954

BURDOCK ROOT DRY

A, H

955

BURDOCK ROOT POWDER

A, H

956

BUSHMASTER SNAKE

H

Only for use as an active homoeopathic ingredient.

957

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%.

958

BUTANE

E

Only for use as an excipient propellant ingredient.

959

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%.

960

BUTTER

E

961

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%.

962

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%.

963

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%.

964

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%.

965

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%.

966

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%.

967

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%.

968

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%.

969

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).

970

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%.

971

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.

972

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%.

973

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%.

974

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%.

975

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%.

976

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%.

977

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%.

978

BUTYL STEARATE

E

Only for use in topical medicines for dermal application.

979

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%.

980

BUTYLATED HYDROXYANISOLE

E

When used as an antimicrobial preservative, the medicine requires the warning statement:

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

981

BUTYLATED HYDROXYTOLUENE

E

982

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%.

983

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%.

984

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%.

985

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%.

986

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%.

987

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%.

988

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%.

989

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%.

990

C10-30 CHOLESTEROL/LANOSTEROL ESTERS

E

Only for use in topical medicines for dermal application.

991

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%.

992

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.

993

C12-13 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 0.125%.

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

994

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%.

995

C12-15 ALKYL OCTANOATE

E

Only for use in topical medicines for dermal application.

996

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%.

997

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%.

998

C13-14 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

999

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%.

1000

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%.

1001

C18-36 ACID GLYCOL ESTER

E

Only for use topical medicines for dermal application.

1002

C18-36 ACID TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1003

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%.

1004

C20-40 ALCOHOLS

E

Only for use in topical medicines for dermal application.

1005

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%.

1006

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%.

1007

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%.

1008

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%.

1009

C9-11 ISOPARAFFIN

E

Only for use in topical medicines for dermal application.

1010

C9-11 PARETH-3

E

Only for use in topical medicines for dermal application.

1011

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%

1012

CABBAGE

E

1013

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%.

1014

CADE OIL

A, E, H

1015

CAESALPINIA SAPPAN

A, H

1016

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 (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]'.

1017

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'.

1018

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

1019

CALCIFIED LITHOTHAMNION SPECIES

A

Only for use in oral medicines.

1020

CALCIFIED LITHOTHAMNION TOPHIFORME

A

Only for oral use.

1021

CALCIUM ALGINATE

E

1022

CALCIUM AMINO ACID CHELATE

A, 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 calcium amino acid chelate must be no more than 25% w/w.

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 ASCORBATE

A, E, H

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

The percentage of ascorbic acid from calcium ascorbate should be calculated based on the molecular weight of calcium ascorbate.

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.

1024

CALCIUM ASCORBATE DIHYDRATE

A, E, H

The percentage of ascorbic acid from Calcium ascorbate dihydrate should be calculated based on the molecular weight of Calcium ascorbate dihydrate.

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

1025

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.

1026

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.

1027

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.

1028

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.’

1029

CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE

A, H

The declared quantity of Calcium from Calcium beta-hydroxy-beta-methylbutyrate monohydrate must be no less than 13.07% and must be no more than 14.45% of the Calciumbeta-hydroxy-beta-methylbutyrate 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.’

1030

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.

1031

CALCIUM CASEINATE

E

1032

CALCIUM CHLORIDE DIHYDRATE

E

1033

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 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 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.

1035

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.

1036

CALCIUM FLUORIDE

H

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

The concentration of fluoride in the product from all ingredients must be no more than 10mg/kg or 10mg/L or 0.1%.

1037

CALCIUM FOLINATE

A

Folinic acid is a mandatory component of calcium folinate.

The maximum daily dose must provide no more than 500 micrograms of folinic acid.

When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine provides not more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts 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.' When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects, the following statement must be included on the label:

- (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect)’

1038

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.

1039

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.

1040

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.

1041

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.

1042

CALCIUM HEXAFLUOROSILICATE

H

Only for use as an active homoeopathic ingredient.

1043

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.

1044

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.

1045

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.

1046

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 Pharmacopoeia as in force or existing from time to time.

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.

1047

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.

1048

CALCIUM HYPOPHOSPHITE

H

Only for use as an active homoeopathic ingredient.

1049

CALCIUM IODIDE

H

Only for use as an active homoeopathic ingredient.

1050

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%

1051

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.

1052

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.

1053

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.

1054

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.

1055

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.

1056

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.

1057

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.

1058

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.

1059

CALCIUM OXIDE

E

Only for use in topical medicines for dermal application.

1060

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:

1061

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.

1062

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.

1063

CALCIUM SACCHARATE

E

1064

CALCIUM SILICATE

E

1065

CALCIUM SODIUM CASEINATE

A, H

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

 - (COWMK) 'Derived from cow's milk'.

1066

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.

1067

CALCIUM STEARATE

E

1068

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.

1069

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.

1070

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.

1071

CALCIUM SULFIDE

H

Only for use as an active homoeopathic ingredient.

1072

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.

1073

CALENDULA FLOWER DRY

A, E, H

1074

CALENDULA FLOWER POWDER

A, H

1075

CALENDULA OFFICINALIS

A, E, H

1076

CALLERYA RETICULATA

A, H

1077

CALLICARPA PEDUNCULATA

A, H

1078

CALLISTEMON CITRINUS

A, H

1079

CALLISTEPHUS CHINENSIS

A, H

1080

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%.

1081

CALLITRIS RHOMBOIDEA

A, H

1082

CALLUNA VULGARIS

A, E, H

1083

CALOCHORTUS TOLMIEI

A, H

1084

CALTHA PALUSTRIS

A, H

1085

CALUMBA ROOT DRY

A, H

1086

CALUMBA ROOT POWDER

A, H

1087

CALVATIA GIGANTEA

A, E, H

1088

CALYCANTHUS FLORIDUS

A, H

1089

CALYCANTHUS PRAECOX

A, H

1090

CAMELLIA JAPONICA

A, H

1091

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.

1092

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.

1093

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%.

1094

CAMPHOR

E, H

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

In liquid preparations the concentration of camphor must be no more than 2.5%.

1095

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%.

1096

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 millilitres, 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 words to that effect); and

- (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 less than 15 millilitres, 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 words to that effect); and

- (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 millilitres but less than or equal to 25 millilitres, 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 words to that effect); and

- (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 millilitres.

When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, 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 words to that effect); and

- (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 millilitres, 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 words to that effect); and

- (NTAKEN) 'Not to be taken'.

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

When for topical use then the concentration of safrole in a medicine must be no more than 1.0%.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25mL.

1097

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 millilitres, 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 words to that effect); and

- (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 less than 15 millilitres, 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 words to that effect); and

- (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 millilitres but less than or equal to 25 millilitres, 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 words to that effect); and

- (NTAKEN) 'Not to be taken'.

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

When for topical use then the concentration of safrole in a medicine must be no more than 1.0%.

If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25mL.

1098

CAMPSIS GRANDIFLORA

A, H

1099

CANADA BALSAM

A, H

1100

CANANGA ODORATA

A, E, H

1101

CANANGA OIL

A, E, H

1102

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).

1103

CANARIUM LUZONICUM

A, H

1104

CANDELILLA WAX

A, E, H

1105

CANDIDA ALBICANS

H

Only for use as an active homoeopathic ingredient.

1106

CANDIDA UTILIS

A, H

1107

CANINE MILK

H

Only for use as an active homoeopathic ingredient.

1108

CANOLA OIL

A, E, H

Allyl isothiocyanate is a mandatory component of canola oil when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

1109

CANTHARIDES

H

Only available as an active homoeopathic ingredient.

1110

CANTHAXANTHIN

E

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

1111

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%.

1112

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%.

1113

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%.

1114

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%.

1115

CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE

E

1116

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%

1117

CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE

E

Only for use in topical medicines for dermal application.

1118

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%

1119

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%.

1120

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%

1121

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%.

1122

CAPSELLA BURSA-PASTORIS

A, H

1123

CAPSICUM

E, H

Only for use as an active homoeopathic or excipient ingredient.

1124

CAPSICUM ANNUUM

A, E, H

1125

CAPSICUM DRY

A, E, H

1126

CAPSICUM FRUIT OLEORESIN

A, E

1127

CAPSICUM FRUTESCENS

A, E, H

1128

CAPSICUM POWDER

A, E, H

1129

CARALLUMA ADSCENDENS VAR. FIMBRIATA

A

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

1130

CARAMEL

E

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

1131

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.

1132

CARAWAY DRY

A, H

1133

CARAWAY OIL

A, E, H

1134

CARAWAY POWDER

A, H

1135

CARBOMER 1342

E

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

1136

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.

1137

CARBOMER 934

E

Only for use in topical medicines for dermal application.

1138

CARBOMER 934P

E

Only for use in topical medicines for dermal application.

1139

CARBOMER 940

E

Only for use in topical medicines for dermal application.

1140

CARBOMER 941

E

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

1141

CARBOMER 954

E

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

1142

CARBOMER 980

E

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

1143

CARBOMER 981

E

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

1144

CARBOMER COPOLYMER (TYPE B)

E

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

1145

CARBOMER HOMOPOLYMER (TYPE B)

E

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

1146

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%.

1147

CARBON

E, H

Only for use as an active homoeopathic or excipient ingredient.

1148

CARBON BLACK

E

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

1149

CARBON DIOXIDE

E

1150

CARDAMOM FRUIT DRY

A, H

1151

CARDAMOM FRUIT POWDER

A, E, H

1152

CARDAMOM OIL

A, E, H

1153

CARDIOSPERMUM HALICACABUM

A, H

1154

CARICA PAPAYA

A, E, H

1155

CARLINA ACAULIS

A, H

1156

CARMELLOSE

E

1157

CARMELLOSE CALCIUM

E

1158

CARMELLOSE SODIUM

E

1159

CARMINE

E

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

1160

CARMOISINE

E

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

1161

CARMOISINE ALUMINIUM LAKE

E

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