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

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).

Fire Safety Warning

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.

Slip Hazard Warning

This preparation may make skin and surfaces slippery – particular care is needed when bathing.

Excipient Warnings

Aqueous cream contains sodium lauryl sulfate which may cause local skin reactions (such as stinging or burning sensation) or increase skin reactions caused by other products when applied on the same area, particularly in children with atopic eczema.

Aqueous cream contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis).

Aqueous cream contains chlorocresol which may cause allergic reactions.

Keep 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)

Chlorocresol

Purified 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: 500g

or Pigmented LDPE/HDPE tube fitted with a polypropylene screw cap.

Pack sizes: 60g, 100g

or Laminate tube fitted with a polypropylene screw cap.

Pack sizes: 60g, 100g

Not applicable.