Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
SULFUR, SALICYLIC ACID
Collective Chemical Company Ltd.
QD11AC08
SULFUR, SALICYLIC ACID
Per Cent
Gel
LM-Licensed Merchant
Bovine
Sulfur compounds
N.S.A.I.D
Authorised
1993-03-12
IRISH MEDICINES BOARD ACT 1995 EUROPEAN COMMUNITIES (ANIMAL REMEDIES) (NO. 2) REGULATIONS 2007 (S.I. NO. 786 OF 2007) VPA: 10914/001/001 Case No: 7004549 The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies (No. 2) Regulations (S.I. No. 786 of 2007) hereby grants to: COLLECTIVE CHEMICAL COMPANY LTD. 43 BIBURY AVENUE, STOKE LODGE, BS12 6DF, UNITED KINGDOM an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the Veterinary Medicinal Product: GOLDEN UDDER GEL The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may be specified in the said Schedule. The authorisation, unless previously revoked, shall continue in force from 11/03/2008. Signed on behalf of the Irish Medicines Board ________________ A person authorised in that behalf by the said Board. (NOTE: From this date of effect, this authorisation replaces any previous authorisation in respect of this product which is now null and void.) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 22/08/2009_ _CRN 7004549_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Golden Udder Gel 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active substances Sulphur for External Use 10.0 % w/w Salicylic Acid 1.5 % w/w For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Gel. A yellow aqueous gel. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Bovine 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES An aid in the control of bovine mastitis. For the treatment of minor skin conditions. 4.3 Read the complete document