ZEROBASE CREAM - summary of medicine characteristics

Zerobase Cream.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Liquid paraffin 11% w/w.

Excipient(s) with known effect

Cetostearyl alcohol 7.2% w/w

Chlorocresol 0.1% w/w

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cream.

Zerobase cream is a white, soft cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Zerobase cream is an emollient, moisturising and protective cream for followup treatment with topical steroids or in spacing such treatment. It may also be used as a diluent for topical steroids. Zerobase cream is recommended for the symptomatic treatment of red inflamed, damaged, dry or chapped skin, the protection of raw skin areas and as a pre-bathing emollient for dry/eczematous skin to alleviate drying areas.

4.2 Posology and method of administration

Adults and children:

The cream should be applied to the dry skin areas as often as is required and rubbed well into the skin.

4.3 Contraindications

There are no absolute contraindications to the use of the cream other than hypersensitivity to any of the ingredients.

4.4 Special warnings and precautions for use

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.

This product contains Chlorocresol and Cetostearyl alcohol which may cause allergic and local skin reactions (e.g. contact dermatitis).

4.5 Interaction with other medicinal products and other forms of interaction

None relevant.

4.6 Fertility, pregnancy and lactation

No risks to pregnant or breastfeeding women have been identified.

4.7 Effects on ability to drive and use machines

None relevant.

4.8 Undesirable effects

Rarely mild skin reactions have been observed.

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

Not relevant.

5.1 Pharmacodynamic properties

The active ingredient in Zerobase cream is liquid paraffin. This provides an emollient, moisturising action on dry or chapped skin.

5.2 Pharmacokinetic properties

Not applicable due to the topical administration and direct action on the skin.

5.3 Preclinical safety data

Not relevant.

6.1 List of excipients

White soft paraffin

Cetostearyl alcohol

Cetomacrogol

Sodium dihydrogen phosphate

Chlorocresol

Phosphoric acid

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

500 gram polypropylene container with LDPE lid and pump dispenser.

50 gram lacquered aluminium tube with HDPE screw cap.