Germolene Antiseptic Cream

Cream for topical administration.

The product will be recommended as an antiseptic (to help prevent secondary infection), local anaesthetic and emollient for minor cuts and grazes, minor burns and scalds and blisters, stings and insect bites, spots and other minor skin conditions, chapped or rough skin.

All age groups:

Thoroughly clean the affected area of skin, apply the cream and rub gently. In the case of cuts or particularly tender areas, rubbing may be avoided by applying on a piece of white lint or gauze.

Known hypersensitivity to any of the constituents.

Consult your doctor if symptoms persist.

Keep out of the reach of children

For external use only

Replace cap firmly after use

Chlorhexidine is incompatible with anionic agents.

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

None known.

Rarely irritancy, rashes and other skin conditions 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 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 and headache.

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.

The product has a local action with minimal risk of systemic effects.

Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product.

Cetostearyl alcohol

Light liquid paraffin

Polyoxyethylene - (21) - stearyl ether

Polyoxyethylene - (2) - stearyl ether

Dimeticone

Methyl salicylate

Sunset yellow (E110)

Ponceau 4R (E124)

Purified water

Chlorhexidine is incompatible with anionic agents.

Three years

Do not store above 25^oC.

a) Flexible aluminium tubes internally lacquered, fitted with an integral nozzle and a polypropylene cap. 5 g, 30 g, 33 g, 55 g or 120 g tubes are contained in boxboard carton.

b) Aluminium laminate tubes for 5g, 20g, 30g, 33g, 35g, 40g or 55g pack sizes consisting of 150μm polyethylene / 5μm polyacrylate outer layer, 30μm aluminium and an inner layer of 30μm polyacrylate / 60μm polyethylene, fitted with a HD polyethylene shoulder, an aluminium/surlyn tamper evident seal, with a polypropylene cap.

Not applicable.

Bayer plc

Trading as: Bayer plc; Consumer Care Division

Bayer House

Strawberry Hill

Newbury

Berkshire

RG14 1JA

United Kingdom

PL 00010/0263

1^st July 2000

November 2010