SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Phenol and Chlorhexidine Digluconate Antiseptic Cutaneous Spray

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Phenol 1.20% w/v

Chlorhexidine digluconate (20%) solution 1.33% w/v (equivalent to chlorhexidine digluconate 0.25% w/v)

For full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Cutaneous spray, solution (Cutaneous Spray).

A clear, pale pink liquid with a characteristic odour.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

An antiseptic and cleansing agent (to help prevent secondary infection) and local anaesthetic for symptomatic relief of minor cuts and grazes, minor burns and scalds and blisters, stings and insect bites, spots and other minor skin disorders.

4.2 Posology and method of administration

Route of administration: Cutaneous Use - external application to the skin.

All age groups: Use undiluted. Spray onto the affected area to wash away debris and dirt. If necessary use cotton wool or a clean tissue to remove dirt and excess liquid. Repeat procedure if necessary.

4.3    Contraindications

Known hypersensitivity to any of the constituents.

4.4    Special warnings and precautions for use

If symptoms persist or if skin irritation occurs, stop using and consult your doctor.

Keep out of the reach and sight of children.

For external use only.

Keep away from eyes, ears and mouth.

If you accidentally spray this product in your eye, wash thoroughly with water.

Consult a doctor promptly if contact is made with eyes or if product is swallowed.

Do not use as a mouth wash or gargle.

4.5    Interaction with other medicinal products and other forms of interaction

None stated.

4.6 Fertility, Pregnancy and Lactation

Pregnancy

The product is not contra-indicated during pregnancy. However, as with all medicines, caution should be exercised when prescribing to pregnant women.

Lactation

Phenol and chlorhexidine digluconate is not excreted in breast milk. Antiseptic Cutaneous Spray can be used during lactation.

4.7 Effects on ability to drive and use machines

None stated.

4.8 Undesirable effects

ADR are rare. The most commonly reported are skin and sub-cutaneous tissue disorders: local irritation, rashes and other skin reactions. These are usually mild and disappear if treatment is discontinued.

4.9 Overdose

Repeated topical application

Frequently repeated topical application on the same site could theoretically lead to skin irritation. However, since the product is only intended for minor skin trauma, extensive exposure is unlikely.

Accidental or deliberate oral ingestion

The product would only be expected to be harmful if orally ingested in very large quantities. This is unlikely due to the unpleasant taste of the product. In such a case, the primary concern would be the phenol intake which can cause nausea, vomiting, diarrhoea, headache and, in large amounts, excitement of respiratory stimulation leading to drowsiness and coma. The lethal dose of phenol has been estimated to be 15 grams.

Treatment

Gastric lavage with water and charcoal. Administration of demulcents such as egg white or milk and supportive measures.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic Group (ATC Codes):

D08AC52 (antiseptics and disinfectants: chlorhexidine, combinations) D08AE03 (antiseptics and disinfectants: phenol and derivatives)

Phenol - antiseptic and local anaesthetic. Chlorhexidine digluconate - antiseptic.

Pharmacokinetic properties

Not applicable.

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 SPC.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Cocamidopropylamine oxide solution (30%)

Denatured ethanol B Perfume Medic 9884 Denatonium solution (0.25%)

Ponceau 4R (E124)

Purified water

6.2 Incompatibilities

Chlorhexidine is incompatible with anionic agents

6.3 Shelf life

36 months

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5 Nature and contents of container

A clear, straight-sided, oval, PVC bottle with a PVC pump spray, containing 50, 100, 150 or 200 ml. Each bottle may be contained in a boxboard carton.