This information is intended for use by health professionals
Aqueous Cream BP
Adults, children and the elderlyTo be applied to the skin as required.
Paediatric populationAqueous cream contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact dermatitis), particularly in children with atopic eczema. An audit of children attending a paediatric dermatology clinic recorded the proportion of immediate cutaneous reactions to emollients (defined as one or more of burning, stinging, itching and redness developing within 20 minutes of application). Aqueous cream was the emollient used by most (71%), which was associated with an immediate cutaneous reaction in 56% of exposures, compared with 18% with other emollients used (details of the other emollients were not reported; n = 100). Aqueous cream should be applied in the direction of hair growth to reduce the risk of folliculitis.The risk of fire should be considered when using large quantities of any paraffin-based emollient. Aqueous cream in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when this preparation is applied to large areas of the body and clothing or dressings become soaked with the emollient. Patients should be told to keep away from fire or flames and not to smoke when using this preparation.This preparation may make skin and surfaces slippery particular care is needed when bathing.Aqueous cream also contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).The package leaflet/label should include the following information: Contains sodium lauryl sulfate which may cause local skin reactions (e.g. stinging and contact dermatitis).Keep all medicines out of the reach of children.Store below 25°C.Do not freeze.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.
Reporting of suspected adverse reactionsReporting 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.
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