Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ZINC OXIDE CASTOR OIL CETOSTEARYL ALCOHOL BEESWAX ARACHIS OIL
Foran Chemicals Ltd
ZINC OXIDE CASTOR OIL CETOSTEARYL ALCOHOL BEESWAX ARACHIS OIL
7.5 %w/w
Cream
Withdrawn
2003-09-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Zinc and Castor Oil Cream B.P. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Oxide Ph. Eur. 7.5% w/w. 3 PHARMACEUTICAL FORM Cutaneous cream A smooth white to off-white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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 4.2.1. DOSAGE The cream is applied after washing and drying the affected area. This is repeated at each nappy change in the case of nappy rash. 4.2.2.ADMINISTRATION Cutaneous (topical) use only. 4.3 CONTRAINDICATIONS Use in persons hypersensitive to any of the ingredients of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interactions known. 4.6 PREGNANCY AND LACTATION Use in pregnancy and lactation has not been established for this product, however, due to the established nature of the ingredients, no adverse effects are anticipated. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 04/08/2006_ _CRN 2026407_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Not applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Zinc & Castor Oil Cream B.P. is used as an emollient and astringent skin application. 5.2 PHARMACOKINETIC PROPERTIES Not relevant. 5.3 PRECLINICAL SAFETY DATA Zinc Oxide Skin and eye irritation : Skin (rabbit) : 500 mg/24H - Mild Eye (rabbit) : 500mg/24H - Mild 6 PHARMACEUTICAL P Прочитайте повний документ