Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
DIPHENHYDRAMINE HYDROCHLORIDE ZINC OXIDE CAMPHOR
McNeil Healthcare (Ireland) Ltd
DIPHENHYDRAMINE HYDROCHLORIDE ZINC OXIDE CAMPHOR
1/8/0.1%w/ %w/w
Cream
Product not subject to medical prescription
Withdrawn
2012-07-17
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benadryl Skin Allergy Relief Cream Diphenhydramine hydrochloride 1.0% w/w Zinc Oxide 8.0% w/w Racemic Camphor 0.1% w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benadryl Skin Allergy Relief Cream contains: The cream also contains: For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cream A smooth, pink cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benadryl Skin Allergy Relief Cream is indicated in the topical treatment of skin manifestations of allergy (e.g., urticaria and hives), and for the relief of irritation associated with shingles, sunburn, prickly heat and other minor skin affections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: Topical. Benadryl Skin Allergy Relief Cream may be applied to affected parts, three to four times daily. CHILDREN AND INFANTS: Topical. As for adults. THE ELDERLY: Topical. As for adults. Diphenhydramine hydrochloride 1 % w/w Zinc oxide 8 % w/w Racemic camphor 0.1 % w/w Cetostearyl Alcohol 8.9 % w/w Propyl Parahydroxybenzoate (E216) 0.2 % w/w Propylene Glycol 10 % w/w IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 15/02/2012_ _CRN 2111836_ _page number: 1_ 4.3 CONTRAINDICATIONS Do not use on chicken pox or measles or exudative dermatoses, unless supervised by a doctor. Do not use on extensive areas of the skin except as directed by a doctor. Do not use any other drugs containing diphenhydramine whilst using this product. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benadryl Skin Allergy Relief Cream should not be applied to raw, or broken surfaces or mucous membranes as this may result in percutaneous absorption giving rise to systemic effects. Avoid contact with the Pročitajte cijeli dokument