国家: 马耳他
语言: 英文
来源: Medicines Authority
CALAMINE, ZINC OXIDE
Bell Sons & Co. (Druggists) Limited Gifford House, Slaidburn Crescent, Southport, Mersyside PR 9 9AL, United Kingdom
D02AX
CALAMINE 100 % (W/V) ZINC OXIDE 15 % (W/V)
CUTANEOUS SUSPENSION
CALAMINE 100 % (W/V) ZINC OXIDE 15 % (W/V)
OTC
EMOLLIENTS AND PROTECTIVES
Withdrawn
2006-05-31
Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS PRODUCT SUMMARY 1. NAME OF THE MEDICINAL PRODUCT Calamine Lotion BP 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Calamine BP 15% w/v Zinc Oxide BP 5% w/v 3. PHARMACEUTICAL FORM Cutaneous suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Use as a mild astringent, cooling lotion for minor skin irritations and sunburn. Administered by application to skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For children, adults and the elderly apply with cotton wool to the affected area as required. 4.3 CONTRA-INDICATIONS Known hypersensitivity to any of the ingredients 4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE Shake bottle well. For external use only. Do not use on broken skin. 4.5 INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known 4.6 PREGNANCY AND LACTATION Acceptable for use in pregnancy and lactation. Page 2 of 3 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None 4.8 UNDESIRABLE EFFECTS None known 4.9 OVERDOSE If accidentally ingested treat symptomatically. 5. PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Calamine has a mild astringent on the skin and is used to relieve the discomfort of dermatitis. Calamine lotion cools the skin by evaporation and is useful for allaying the pain and swelling of sunburn. Zinc oxide is applied externally as a mild astringent for the skin and protective application in eczema and as a protective for slight excoriations. 5.2 PHARMACOKINETIC PROPERTIES Not applicable 5.3 PRECLINICAL SAFETY DATA None available 6. PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Bentonite BP Sod 阅读完整的文件