国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
Zinc oxide
Clonmel Healthcare Ltd
D02AB
Zinc oxide
15 percent weight/weight
Ointment
Product not subject to medical prescription
Zinc products
Marketed
1985-01-08
Health Products Regulatory Authority 15 November 2019 CRN008JXK Page 1 of 3 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Caldease 15% w/w Medicated Ointment 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc oxide 15% w/w. Excipients with known effect Methylhydroxybenzoate 0.40 % w/w, Propylhydroxybenzoate 0.10 % w/w, Lanolin oil 5.00 % w/w For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Ointment A grey-white ointment with characteristic odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Caldease Ointment promotes the healing of nappy rash. Protects irritated skin and smoothes minor skin irritations, superficial wounds and burns. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Apply each time after area has been cleansed and dried. _Nappy rash_ To help prevent nappy rash, apply a smooth even coating of ointment at each nappy change. There is no recommended dose schedule. Method of administration For topical administration only. 4.3 CONTRAINDICATIONS 1. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 2. Use in the treatment of fungal infections. 3. Use on large surface wounds and major burns. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If there is no improvement, or there is aggravation of the condition, consult the doctor. Contains parahydroxybenzoates which may cause allergic reactions (possibly delayed). Contains lanolin oil which may cause local skin reactions (e.g., contact dermatitis). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Health Products Regulatory Authority 15 November 2019 CRN008JXK Page 2 of 3 None. 4.6 FERTILITY, PREGNANCY AND LACTATION None. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES None. 4.8 UNDESIRABLE EFFECTS None. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professional 完全なドキュメントを読む