Nchi: Ayalandi
Lugha: Kiingereza
Chanzo: HPRA (Health Products Regulatory Authority)
LIDOCAINE HYDROCHLORIDE CLOVE OIL
William Ransom & Son Plc
0.7/10.0 %w/w
Gingival solution
2005-05-27
IRISH MEDICINES BOARD ACT 1995, AS AMENDED MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED PA0506/022/001 Case No: 2050586 The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to WILLIAM RANSOM & SON PLC STEPFIELD, WITHAM, ESSEX CM8 3AG, ENGLAND an authorisation, subject to the provisions of the said Regulations, in respect of the product SOOTHAKE TOOTHACHE TINCTURE the particulars of which are set out in 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 04/04/2008. Signed on behalf of the Irish Medicines Board this ________________ A person authorised in that behalf by the said Board. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/08/2010_ _CRN 2050586_ _page number: 1_ PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Soothake Toothache Tincture 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Also contains Ethanol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Gingival Solution A colourless or pale yellow solution 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the temporary relief of toothache. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply as needed at four hourly intervals. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Flammable. In case of persistent pain consult your dentist. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 PREGNANCY AND LA Soma hati kamili