Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
PARAFFIN, LIQUID
Stiefel Laboratories (U.K.) Ltd.
7.5 %w/w
Soap
1992-02-25
IRISH MEDICINES BOARD ACT 1995 MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998 (S.I. NO.142 OF 1998) PA0144/044/001 Case No: 2029075 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to STIEFEL LABS (U.K.) LTD. HOLTSPUR LANE, WOOBURN GREEN, HIGH WYCOMBE, BUCKS HP10 0AU, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product STIEFEL EMOLLIENT SOAP The particulars of which are set out in Part I and Part II of the attached Schedule. The authorisation is also subject to the general conditions as may be specified in the said Regulations as listed on the reverse of this document. This authorisation, unless previously revoked, shall continue in force from 25/02/2007. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 28/03/2007_ _CRN 2029075_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Stiefel Emollient Soap 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains liquid paraffin 7.5 % w/w For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Medicated Soap A salmon pink, oval soap bar. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Stiefel Emollient Soap is indicated as a gentle cleanser for dry sensitive skin. It is suitable for the treatment of diseases where ordinary soaps have an adverse effect, such as pruritus, eczema and atopic dermatitis. The use of Stiefel Emollient Soap in these conditions will cleanse, soothe and hydrate the skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Stiefel Emollie Read the complete document