देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
CALAMINE ZINC OXIDE
Ricesteele Manufacturing Ltd
15, 5 %w/v
Cutaneous Suspension
1993-04-27
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calamine Lotion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calamine 15% w/v and Zinc Oxide 5% w/v. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous suspension Pink cutaneous suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calamine lotion has mild astringent and soothing properties. It is indicated for the management of minor pruritic conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use. Shake bottle before use. Apply to affected area three times daily as required. 4.3 CONTRAINDICATIONS None. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product is for external use only. If symptoms persist or worsen consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 PREGNANCY AND LACTATION Safety in pregnancy has not been established. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 11/07/2006_ _CRN 2025353_ _page number: 1_ 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Not Applicable. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Calamine Lotion acts locally on the skin and has mild astringent and soothing properties. 5.2 PHARMACOKINETIC PROPERTIES No information available. 5.3 PRECLINICAL SAFETY DATA Calamine and Zinc Oxide are well established drug substances and have been widely used for many years. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Bentonite Sodium Citrate Phenol Glycerol Purified Water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE 2 years. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25ºC. 6.5 NATURE AND CONTENTS OF CONTAINER Amber Type III sod पूरा दस्तावेज़ पढ़ें