QUALITATIVE AND QUANTITATIVE COMPOSITION Phenol Ph. Eur. 1.2% w/w Chlorhexidine Digluconate Solution Ph. Eur. To give Chlorhexidine Digluconate 0.25% w/w
PHARMACEUTICAL FORM Cream for topical administration. 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. 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.
Contraindications Known hypersensitivity to any of the constituents. 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 Interaction with other medicinal products and other forms of interaction Chlorhexidine is incompatible with anionic agents.
Pregnancy and lactation The product is not contraindicated during pregnancy and lactation. However, as with all medicines during pregnancy, caution should be exercised.
Undesirable effects Rarely irritancy, rashes and other skin conditions may occur. 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 that 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.
Pharmacodynamic properties Phenol – antiseptic and local anaesthetic. Chlorhexidine digluconate – antiseptic. Pharmacokinetic properties The product has a local action with minimal risk of systemic effects. Preclinical safety data Preclinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings that are of relevance to the recommended dosage and use of the product.
PHARMACEUTICAL PARTICULARS 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) Deionised water. Incompatibilities Chlorhexidine is incompatible with anionic agents. Shelf life Three years Special precautions for storage Do not store above 25oC.
Nature and contents of container a) Flexible aluminium tubes internally lacquered fitted with an integral nozzle and a polypropylene cap. 30g tube is contained in boxboard carton. b) Aluminium laminate tubes for 30g pack size 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.
All products meet the Irish Medicines Board requirements