Emulsifying Ointment BP

For external use only.

Used to prepare Aqueous Cream BP and Buffered Cream BP.

The product is used by the pharmacist to prepare Aqueous Cream and Buffered Cream and therefore is not sold with any clinical indications or dosage schedules.

Hypersensitivity to any of the ingredients.

Emulsifying ointment has been found to have major sunscreen activity in clinically normal skin. Preparations containing emulsifying ointment should not be used before phototherapy or in phototesting procedures.

For external use only.

Emulsifying wax (which contains sodium lauryl sulphate and cetostearyl alcohol) may cause local skin reactions (e.g. stinging, burning, itching, redness and contact dermatitis), particularly in children with atopic eczema.

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).

The risk of fire should be considered when using large quantities of any paraffin-based emollient. Emulsifying ointment 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.

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.

None known.

The safety of Emulsifying Ointment during pregnancy and lactation has not been established.

Does not affect ability to drive or use machines.

Immune system disorders: Occasional allergic reactions

Skin and subcutaneous tissue disorders: Emulsifying ointment may exacerbate acne and/or folliculitis. Emulsifying wax contains sodium lauryl sulphate and cetostearyl alcohol which may be associated with local skin reactions (e.g. stinging, burning, itching, redness and contact dermatitis) particularly in patients with eczema. See section 4.4. Rash

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..

Overdose is considered unlikely with this product when used as indicated. Symptoms of accidental oral ingestion may include gastrointestinal symptoms, particularly diarrhoea and should be treated symptomatically.

The active ingredients white soft paraffin and liquid paraffin are recognised emollients and in mixture with emulsifying wax will produce a stable cream when mixed with water – as in the preparation of Aqueous Cream.

Not applicable.

No further information of significance to prescriber.

None used.

None.

36 months

Store below 25° C. Do not freeze.

None.