देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
DIPHENHYDRAMINE HYDROCHLORIDE ZINC OXIDE CAMPHOR
McNeil Healthcare (Ireland) Ltd
1/8/0.1%w/
Cutaneous Suspension
1994-04-01
IRISH MEDICINES BOARD ACTS 1995 AND 2006 MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007 (S.I. NO.540 OF 2007) PA0823/016/002 Case No: 2050321 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to MCNEIL HEALTHCARE (IRELAND) LTD AIRTON ROAD, TALLAGHT, DUBLIN 24, IRELAND an authorisation, subject to the provisions of the said Regulations, in respect of the product BENADRYL SKIN ALLERGY RELIEF LOTION 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 21/05/2008 until 31/03/2009. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/05/2008_ _CRN 2050321_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Benadryl Skin Allergy Relief Lotion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benadryl Skin Allergy Relief Lotion contains: For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cutaneous liquid A smooth, pink viscous cutaneous liquid. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Benadryl Skin Allergy Relief Lotion is indicated in the topical treatment of skin manifestations of allergy (e.g., urticaria and hives), and for the relief of irritation associated with shingles, sunburn, prickly heat and other minor skin affections. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ADULTS: Topical. Benadryl Skin Allergy R पूरा दस्तावेज़ पढ़ें