Cetraben Advance Emollient Cream
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cetraben Advance Emollient Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
White Soft Paraffin 13.2% w/w Light Liquid Paraffin 10.5% w/w
For full list of 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 Advance 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
Topical administration: Cetraben Advance Emollient 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
This product contains Cetostearyl alcohol which may cause local skin reactions.
Interaction with other medicinal products and other forms of interaction
4.5
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 Advance Emollient Cream have emollient, moisturising and protective properties.
5.2 Pharmacokinetic properties
Cetraben Advance Emollient cream acts only on the skin.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SmPC
PHARMACEUTICAL PARTICULARS
6
6.1 List of excipients
Emulsifying wax
Cetostearyl Alcohol
Glycerol
Phenoxyethanol
Citric Acid Monohydrate
Trisodium Citrate Dihydrate
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 and 50g
Not all pack sizes may be 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 06831/0262
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10 October 2012
10 DATE OF REVISION OF THE TEXT
25/03/2015