This information is intended for use by health professionals
|Active ingredient||% w/w|
|White Soft Paraffin BP||15.0|
|Liquid Paraffin BP||6.0|
Adults, children and elderly:To 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).
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.The package leaflet/label should include the following information: Contains sodium lauryl sulfate and cetostearyl alcohol which may cause local skin reactions (e.g. stinging and contact dermatitis)Contains chlorocresol which may cause allergic reactionsKeep all medicines out of the sight and reach of children.
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.
|Tub:||Store in a cool place.|
9th September 2019