CETRABEN ADVANCE EMOLLIENT CREAM - summary of medicine 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

Excipient(s) with known effect

Emulsifying wax      5.2% w/w

(Containing: Sodium laurilsulfate 0.49% w/w and Cetostearyl alcohol)

Cetostearyl alcohol    6.21% w/w

For the 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 and 0.49% w/w Sodium laurilsulfate which may cause local skin reactions (such as stinging or burning sensations) or increased skin reactions caused by other products when applied on the same area.

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 help reduce product build-up but not totally remove it.

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 or search for ‘MHRA Yellow Card’ in the Google Play or Apple App Store.

4.9 Overdose

None reported.

5.1

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Emulsifying wax (Containing Sodium laurilsulfate and Cetostearyl alcohol)

Cetostearyl Alcohol

Glycerol (E422)

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.