Country: Ireland
Bahasa: Inggeris
Sumber: HPRA (Health Products Regulatory Authority)
CALAMINE ZINC OXIDE
Rowa Pharmaceuticals Limited
Cutaneous Suspension
1994-12-12
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calamine Lotion BP 15% w/v Cutaneous Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Calamine 15% w/v For excipients see 6.1. 3 PHARMACEUTICAL FORM Cutaneous Suspension A pale pink liquid with a faint smell of phenol. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Calamine Lotion is indicated for the symptomatic relief of skin irritation due to sunburn, heat rash and allergic reactions. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION ROUTE OF ADMINISTRATION: cutaneous use RECOMMENDED DOSAGE SCHEDULE: Apply to the affected areas 3-4 times daily or as directed by the physician. 4.3 CONTRAINDICATIONS There are no contra-indications to the use of Calamine Lotion. 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE If symptoms persist consult your doctor. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LACTATION There is no known contra-indication to the use of Calamine Lotion during pregnancy and lactation. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Issued 20/09/2005_ _CRN 2014882_ _page number: 1_ 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None known. 4.8 UNDESIRABLE EFFECTS None known. 4.9 OVERDOSE Not applicable 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Not applicable. 5.2 PHARMACOKINETIC PROPERTIES Not applicable. 5.3 PRECLINICAL SAFETY DATA Not applicable. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Zinc Oxide Bentonite Sodium Citrate Phenol Glycerol Purified Water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE 3 years. 6.4 SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25 o C. IRISH MEDICINES BOARD ____________________________________________ Baca dokumen lengkap