Aqueous Calamine Cream BP

Cream

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 the active substance(s) or to any of the excipients listed in section 6.1.4.4 Special warnings and precautions for use For external use only. Keep securely closed when not in use. Keep out of the sight and reach of children. Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. **Ingredients with specified warnings** This medicine contains Cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).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 known4.8 Undesirable effects Occasional hypersensitivity or irritant reactions **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 or search for 'MHRA Yellow Card' in the Google Play or Apple App Store.4.9 Overdose Not applicable

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

6.1 List of excipients Liquid paraffin, glyceryl monostearate, macrogol cetostearyl ether 22, cetostearyl alcohol, phenoxyethanol, purified water6.2 Incompatibilities None known6.3 Shelf life 36 months unopened Use within 12 months of first opening6.4 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 MDPE laminated plastic tube, with polypropylene cap.6.6 Special precautions for disposal and other handling None