Cetraben Emollient Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetraben Emollient Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin 13.2% w/w Light Liquid Paraffin 10.5% w/w
For excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A thick white cream with the characteristic odour of paraffin oil.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Cetraben Emollient Cream is an emollient, moisturising and protective cream for the symptomatic relief of red, inflamed, damaged, dry or chapped skin, especially when associated with endogenous or exogenous eczema.
4.2 Posology and method of administration
Cetraben Cream should be applied to the dry skin areas as often as required and rubbed in.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
None known.
4.5 Interaction with other medicinal products and other forms of interaction
None known.
4.6 Fertility, pregnancy and lactation
No special precautions are required.
4.7 Effects on ability to drive and use machines
None.
4.8 Undesirable effects
Very rarely, mild allergic skin reactions including rash and erythema have been observed, in which case use of the product should be discontinued.
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
None reported.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: D02A X (Other Emollients and Protectives).
The ingredients of Cetraben Cream have an emollient, moisturising and protective properties.
5.2 Pharmacokinetic properties
Cetraben cream acts only on the skin.
5.3 Preclinical safety data
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Emulsifying wax
Cetyl stearyl Alcohol
Glycerin
Butylparaben
Methylparaben
Ethylparaben
Propylparaben
Phenoxetol
Citric Acid
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf life
Three years
6.4 Special precautions for storage
Do not store above 25°C.
6.5 Nature and contents of container
Polypropylene jars with a pump dispenser of 1050g, 500g, 150g and 50g, polyethylene screw capped jars* or tubes of 125g, polyethylene screw capped jars or tubes of 50g
* not currently marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Genus Pharmaceuticals Linthwaite,
Huddersfield,
HD7 5QH, UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 06831/0259
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/09/2006
10 DATE OF REVISION OF THE TEXT
25/03/2015