1. Name Of The Medicinal Product
Germolene Antiseptic First Aid Wash
also available as Germolene Bites and Stings Spray
2. Qualitative And Quantitative Composition
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
3. Pharmaceutical Form
Cutaneous spray, solution
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
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.
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 Pregnancy And Lactation
The product is not contra-indicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.
4.7 Effects On Ability To Drive And Use Machines
None stated.
4.8 Undesirable Effects
Rarely local irritation, rashes and other skin reactions may occur.
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
Phenol - antiseptic and local anaesthetic.
Chlorhexidine digluconate - antiseptic.
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 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
Bitrex 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
None.
6.5 Nature And Contents Of Container
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.
6.6 Special Precautions For Disposal And Other Handling
None
Administrative Data
7. Marketing Authorisation Holder
Bayer plc
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
Trading as Bayer plc, Consumer Care Division
8. Marketing Authorisation Number(S)
PL 0010/0261
9. Date Of First Authorisation/Renewal Of The Authorisation
Date of first authorisation: 1 July 2000
Date of renewal of authorisation: 16 October 2000
10. Date Of Revision Of The Text
June 2005
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