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CETRABEN EMOLLIENT CREAM

Active substance: WHITE SOFT PARAFFIN

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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.

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
Park View House
65 London Road
Newbury
Berkshire
RG14 1JN
United Kingdom

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
13/10/2012

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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