SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Aqueous Calamine Cream BP

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Calamine 4.0% w/w and Zinc Oxide 3.0% w/w

3    PHARMACEUTICAL FORM

Cream

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For relief of the symptoms of mild sunburn and other minor skin conditions.

4.2    Posology and method of administration

Topical application.

Adults, elderly and children: apply liberally to    dry, clean skin as required.

4.3    Contraindications

Hypersensitivity to phenoxyethanol or any other ingredient.

4.4    Special warnings and precautions for use

For external use only.

Keep securely closed when not in use.

Keep all medicines away from children.

4.5    Interaction with other medicinal products and other forms of interaction

May mask x-ray pictures under certain circumstances.

4.6 Fertility, pregnancy and lactation

No information is available on the use of this product during pregnancy and lactation. However, it is unlikely that its use would cause any adverse effects.

4.7    Effects on ability to drive and use machines

None known

4.8    Undesirable effects

None known

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

4.9    Overdose

Not applicable

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Both Zinc Oxide and Calamine exhibit a mild astringent action when applied to the skin.

5.2    Pharmacokinetic properties

None stated.

5.3    Preclinical safety data

None

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Liquid paraffin, glyceryl monostearate, macrogol cetostearyl ether 22, cetostearyl alcohol, phenoxyethanol, purified water

6.2    Incompatibilities

None known

Shelf life

24 months unopened

6.4    Special precautions for storage

Do not store above 25°C.

Do not allow to freeze.

6.5    Nature and contents of container

100g: White polyethylene/Aluminium/co-polymer LDPE laminated plastic tube, with polypropylene cap.

100g: White polyethylene/Aluminium/co-polymer MDPE laminated plastic tube, with polypropylene cap.

6.6    Special precautions for disposal

None

7    MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd.

Linthwaite Laboratories

Huddersfield

HD75QH

8    MARKETING AUTHORISATION NUMBER(S)

PL 00240/6276R

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/06/1988 /    15/06/2001

10    DATE OF REVISION OF THE TEXT

21/11/2014