Aqueous cream

Aqueous Cream B.P.

Cream

For topical application to the skin:As an emollient for the symptomatic relief of dry skin conditions.As a soap-substitute for skin washing

Adults, children and elderly:

To be applied to the skin as required.

Hypersensitivity to any of the ingredients.

For external use only.

Paediatric population

Aqueous 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.

No clinically significant drug interactions known.

The safety of aqueous cream during pregnancy and lactation has not been established but is not considered to constitute a hazard during these periods.

No adverse effects known.

Occasional allergic reactions.Aqueous cream may be associated with immediate cutaneous reactions when used as a leave-on emollient, such as stinging, burning, itching and redness. See section 4.4.

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.

Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea. Treatment need only be symptomatic.

White soft paraffin and liquid paraffin have emollient properties.

None applicable.

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Emulsifying wax (contains cetostearyl alcohol and sodium lauryl sulfate)ChlorocresolPurified water

Not applicable

36 months

Polypropylene jar with an unlined polypropylene cap.Pack size 500g.or Polypropylene securitub with a white pilfer-proof polythene cap.Pack size: 500gor Pigmented LDPE/HDPE tube fitted with a polypropylene screw cap.Pack sizes: 60g, 100gor Laminate tube fitted with a polypropylene screw cap.Pack sizes: 60g, 100g

Not applicable.

The Boots Company PLCNottinghamNG2 3AATrading as: BCM

PL 00014/5202R

First Authorisation: 16 December 1986Renewal: 16 December 1991

9^th September 2019