ZEROGUENT - summary of medicine characteristics

Zeroguent.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Light liquid paraffin 8.0% w/w.

White soft paraffin 4.0% w/w.

Soya bean oil (refined and deodorised) 5.0% w/w.

Excipient(s) with known effect

Cetostearyl alcohol 7.5% w/w

Sorbic acid 0.2% w/w

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Zeroguent is a smooth white opaque cream.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Zeroguent is used as a diluent for various topical corticosteroid formulations in those instances where a lower strength preparation is considered desirable by the physician and as a general base for extemporaneous dispensing.

Zeroguent is an emollient used for the symptomatic treatment of dermatitis, ichthyosis, eczema, nappy rash, protection of raw and abraded skin areas, pruritis and related skin conditions where dry scaly skin is a problem and as a pre-bathing emollient for dry/eczematous skin, to alleviate drying effects.

4.2 Posology and method of administration

For cutaneous application.

Adults, Children and Elderly:

A thin application of the cream should be gently massaged into the skin three times daily or at appropriate intervals. When used as a protective cream, Zeroguent should be applied sparingly to the affected areas of the skin before or immediately after, exposure to a potentially harmful factor.

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

Ingredients with specified warnings

This product contains soya oil. If you are allergic to peanut or soya, do not use this product.

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

Other warnings

Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, sheets 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.

4.5 Interaction with other medicinal products and other forms of interaction

None known.

4.6 Fertility, pregnancy and lactation

No restrictions on the use of the product in pregnancy and lactation are proposed.

4.7 Effects on ability to drive and use machines

None known.

4.8 Undesirable effects

Rarely mild skin reactions have been observed which may take the form of an allergic rash. Should this occur the use of the product should be discontinued.

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

The cream is of low toxicity. Conservative treatment only is required should accidental ingestion occur.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Code: DO2A C. Emollients and Protectives

The active ingredients in Zeroguent are light liquid paraffin, soft white paraffin and soya bean oil all have emollient properties which maintain the high lipid content of an ointment and also has the water miscible characteristics of a cream. The high lipid content reduces water loss from the skin and therefore has a hydrating effect which aids the recovery from dermatitis, eczema and dry or scaly skin conditions. Zeroguent also contains sorbic acid which has an antibacterial effect.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

There are no preclinical data of relevance to the consumer which are additional to that already included in other sections.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Glyceryl monostearate 40–55 Cetostearyl alcohol

Propylene glycol

Colloidal anhydrous silica

Sorbic acid (E200) Polysorbate 40 (E434) Purified water

Hydrochloric acid

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

Six months after opening.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

500 gram polypropylene jar with LDPE closure

6.6 Special precautions for disposal

None.

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

8 MARKETING AUTHORISATION NUMBER(S)

PL 00240/0421

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

TBC