Germolene Antiseptic First Aid Wash

also available as Germolene Bites and Stings Spray

Phenol 1.20% w/v, chlorhexidine digluconate solution 1.33% w/v equivalent to chlorhexidine digluconate 0.25% w/v.

For excipients, see 6.1

Cutaneous spray, solution

As 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.

Route of administration: 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.

Known hypersensitivity to any of the constituents.

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.

None stated.

The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.

None stated.

Rarely local irritation, rashes and other skin reactions may occur.

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.

Phenol - antiseptic and local anaesthetic.

Chlorhexidine digluconate - antiseptic.

Not applicable.

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

Cocamidopropylamine oxide solution (30%)

Denatured ethanol B

Perfume Medic 9884

Bitrex solution (0.25%)

Ponceau 4R (E124)

Purified water

Chlorhexidine is incompatible with anionic agents

36 months

None.

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

None

Bayer plc

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

Trading as Bayer plc, Consumer Care Division

PL 0010/0261

Date of first authorisation: 1 July 2000

Date of renewal of authorisation: 16 October 2000

June 2005