1. Name Of The Medicinal Product
Germolene Antiseptic Cream
2. Qualitative And Quantitative Composition
Phenol Ph. Eur. 1.2% w/w
Chlorhexidine Digluconate Solution Ph. Eur.
to give Chlorhexidine Digluconate 0.25% w/w
3. Pharmaceutical Form
Cream for topical administration.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
Known hypersensitivity to any of the constituents.
4.4 Special Warnings And Precautions For Use
Consult your doctor if symptoms persist.
Keep out of the reach of children
For external use only
Replace cap firmly after use
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Chlorhexidine is incompatible with anionic agents.
4.6 Pregnancy And Lactation
The product is not contraindicated 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 known.
4.8 Undesirable Effects
Rarely irritancy, rashes and other skin conditions 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 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.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Phenol – antiseptic and local anaesthetic.
Chlorhexidine digluconate – antiseptic.
5.2 Pharmacokinetic Properties
The product has a local action with minimal risk of systemic effects.
5.3 Preclinical Safety Data
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.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Cetostearyl alcohol
Light liquid paraffin
Polyoxyethylene - (21) - stearyl ether
Polyoxyethylene - (2) - stearyl ether
Dimeticone
Methyl salicylate
Sunset yellow (E110)
Ponceau 4R (E124)
Purified water
6.2 Incompatibilities
Chlorhexidine is incompatible with anionic agents.
6.3 Shelf Life
Three years
6.4 Special Precautions For Storage
Do not store above 25oC.
6.5 Nature And Contents Of Container
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, 30g, 33g, 40 g 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.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
Administrative Data
7. Marketing Authorisation Holder
Bayer plc
Trading as: Bayer plc; Consumer Care Division
Bayer House
Strawberry Hill
Newbury
Berkshire
RG14 1JA
United Kingdom
8. Marketing Authorisation Number(S)
PL 00010/0263
9. Date Of First Authorisation/Renewal Of The Authorisation
1st July 2000
10. Date Of Revision Of The Text
June 2006
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