Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Zinc oxide; Castor oil
Ovelle Limited
D02AB
Zinc oxide; Castor oil
7.5 %w/w + 50 percent weight/weight
Ointment
Product not subject to medical prescription
Zinc products
Marketed
1992-10-13
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zinc & Castor Oil Ointment Zinc Oxide 7.5%w/w Castor Oil 50%w/w 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Oxide 7.5% w/w and Castor Oil, virgin 50% w/w. Excipients: contains 2.0% w/w Cetostearyl Alcohol and 30.5% w/w Arachis Oil For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment. A white homogeneous ointment with a characteristic odour and a smooth oily texture. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (a) Zinc & Castor Oil Ointment is used as a topical emollient and astringent skin application. (b) It acts as a soothing and protective application in eczema and as a protective for slight excoriations and sore areas of the skin. It is a protection against nappy rash in infants. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Zinc & Castor Oil Ointment is applied topically and is for external use only. Recommended Use: As an emollient and protective for topical management of nappy rash, pruritus and other mild irritative rashes. Apply as required after cleansing the affected area. If symptoms persist consult your doctor. 4.3 CONTRAINDICATIONS Zinc & Castor Oil Ointment is contra-indicated in patients with a known sensitivity to its ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Zinc & Castor Oil Ointment contains arachis oil (peanut oil). If you are allergic to peanut or soya, do not use this medicinal product. Zinc & Castor Oil Ointment may cause local skin reactions (e.g. contact dermatitis). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Les hele dokumentet