Eumocream 25% w/w

Eumocream 25% w/w

Glycerol 25% w/w

For excipients, see 6.1

Cream

Smooth, white cream

This product is indicated for the management of dry or flaky skin conditions which may also be pruritic such as eczema or dermatitis.

For topical application to the skin.

Adults, the elderly, infants, babies and children:

The cream should be applied to the affected areas as often as required.

Hypersensitivity to any of the ingredients.

Avoid contact with the eyes, as the product may cause irritation to the epithelial cells of the cornea.

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 stated

Animal studies are insufficient with respect to effects on pregnancy, foetal development, parturition or postnatal developments. The potential risk for humans is unknown.

Caution should be exercised when prescribing to pregnant women.

None stated

Hypersensitivity reactions have been rarely reported; they usually consist of localised skin reactions.

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.

Eumocream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.

ATC Code: D02AX

When this product is applied to the skin it acts as an emollient and humectant.

Eumocream is for topical use only. There are no pharmacokinetic data for this product.

There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.

Glycerol monostearate 40-55

Cetostearyl alcohol

Beeswax substitute 6621 (Paraffin wax, Vegetable Stearic acid, Prime Yellow Carnauba wax)

Arlacel 165 (Glycerol Monostearate, Polyoxyethylene 100 Stearate)

Dimeticone

Chlorocresol

Sodium citrate

Citric acid monohydrate

Purified water

Not applicable

36 months

Do not store above 25 °C. Do not freeze.

Collapsible aluminium tube internally lacquered with an epoxy coat, with a latex band and a wadless polypropylene cap.

30 g and 100 g tubes.

None stated

Administrative Data

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

PL 44673/0040

03/04/2007

14/09/2019