Summary of Product Characteristics (SmPC) - Eumocream 25% w/w
1 NAME OF THE MEDICINAL PRODUCT
Eumocream 25% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycerol 25% w/w
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Cream
Smooth, white cream
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
This product is indicated for the management of dry or flaky skin conditions which may also be pruritic such as eczema or dermatitis.
4.2 Posology and method of administration
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.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
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.
4.5 Interaction with other medicinal products and other forms of interaction
None stated
4.6 Pregnancy and lactation
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.
4.7 Effects on ability to drive and use machines
None stated
4.8 Undesirable effects
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.
4.9 Overdose
Eumocream is of low toxicity. If accidental ingestion occurs, conservative treatment only is required.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D02AX
When this product is applied to the skin it acts as an emollient and humectant.
5.2 Pharmacokinetic properties
Eumocream is for topical use only. There are no pharmacokinetic data for this product.
5.3 Preclinical safety data
There are no preclinical data considered relevant to clinical safety beyond data included in other sections of the SPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Glycerol monostearate 40-55
Cetostearyl alcohol
Beeswax substitute 6621 (Paraffin wax, Vegetable Stearic acid, Prime Yellow Camauba wax)
Arlacel 165 (Glycerol Monostearate, Polyoxyethylene 100 Stearate) Dimeticone
Chlorocresol
Sodium citrate
Citric acid monohydrate
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
36 months
6.4 Special precautions for storage
Do not store above 25 °C. Do not freeze.
6.5 Nature and contents of container
Collapsible aluminium tube internally lacquered with an epoxy coat, with a latex band and a wadless polypropylene cap.
30 g and 100 g tubes.
6.6 Special precautions for disposal
None stated
7 MARKETING AUTHORISATION HOLDER
Haleon UK Trading Limited
The Heights
Weybridge
Surrey
KT13 0NY
United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 44673/0040
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/04/2007
10 DATE OF REVISION OF THE TEXT
24/08/2023