ZERONEUM - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Zeroneum.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Soya bean oil, refined 83.35% w/w.

3 PHARMACEUTICAL FORM

Cutaneous Solution.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Dry skin conditions including those associated with dermatitis and eczema.

4.2 Posology and method of administration

For cutaneous use.

The liquid should be added to the bath water.

For full bath (approx. 100 litres) – 20ml (1 measure).

For child’s bath (approx. 25 litres) – 5ml (1/4 measure).

For partial bath (approx. 5 litres) – 2.5ml (1/8 measure).

In particularly dry skin, 2–3 times the above quantities can be used.

Generally, 2–3 baths should be taken weekly. For babies and infants a daily bath is recommended.

4.3 Contraindications

Known hypersensitivity to peanut, soya or any of the ingredients.

4.4 Special warnings and precautions for use

This product contains soya oil and should not be used by patients who are allergic to peanut or soya.

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 Not known.

4.7 Effects on ability to drive and use machines Not applicable.

4.8 Undesirable effects

None.

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

Not applicable.

5.1 Pharmacodynamic properties

Zeroneum was developed in response to the need for a suitable non-irritant cleansing agent for patients with eczema. As the skin in this condition requires the application of large amounts of fat, cleansing properties as well as greasing properties were combined. Zeroneum contains a plant oil having a high proportion of unsaturated fatty acid (linoleic acid up to 60%). The emulsifier used is a mixture of fatty acid amides with aliphatic alcohol and readily dispersible macrogol lauryl ester. Butylated hydroxytoluene is added as an antioxidant.

5.2 Pharmacokinetic properties

Not applicable.

5.3 Preclinical safety data

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

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Macrogol lauryl ether (Laureth-4)

Comperlan (oleic acid diethanolamide)

Butylated hydroxytoluene (E321)

Propylene glycol (E1520)

Perfume (Balneum A167139).

6.2 Incompatibilities

None known.

6.3 Shelf life

24 months.

6.4 Special precautions for storage

Do not store above 25°C.

6.5 Nature and contents of container

Container: HDPE bottle with polypropylene cap containing 500ml of solution.

6.6 Special precautions for disposal None.

7 MARKETING AUTHORISATION HOLDER

Thornton & Ross Ltd

Linthwaite

Huddersfield

HD7 5QH

8 MARKETING AUTHORISATION NUMBER(S)

PL 00240/0424

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

11/08/2008