GERMOLENE OINTMENT 6.55/3/0.3 %w/w Ointment
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
ZINC OXIDE METHYL SALICYLATE OCTAFONIUM CHLORIDE PHENOL
Available from:
Bayer Limited
INN (International Name):
ZINC OXIDE METHYL SALICYLATE OCTAFONIUM CHLORIDE PHENOL
Dosage:
6.55/3/0.3 %w/w
Pharmaceutical form:
Ointment
Prescription type:
Product not subject to medical prescription
Authorization status:
Withdrawn
Authorization date:
2012-11-30
Summary of Product characteristics
IRISH MEDICINES BOARD ACTS 1995 AND 2006
MEDICINAL PRODUCTS(CONTROL OF PLACING ON THE MARKET)REGULATIONS,2007
(S.I. NO.540 OF 2007)
PA1410/046/001
Case No: 2043649
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
Transferred from PA0021/049/001.
BAYER LIMITED
THE ATRIUM, BLACKTHORN ROAD, DUBLIN 18, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GERMOLENE OINTMENT
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 14/05/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/05/2010_
_CRN 2043649_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Germolene Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The ointment contains the following active substances:
Zinc Oxide 6.55% w/w, Methyl Salicylate 3% w/w, Phenol 1.19% w/w and Octafonium Chloride 0.3% w/w.
Excipients: Also contains wool fat (lanolin), 35.0% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
A pink smooth ointment with characteristic medicated odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic and analgesic for the topical treatment of superficial skin trauma, nappy rash, sunburn and painful
muscles.
4.2 POSOLOGY AND METHOD OF ADMINISTRAT
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