GERMOLENE FIRST AID 1.2/0.25 %w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

PHENOL CHLORHEXIDINE DIGLUCONATE (AS CHLORHEXIDINE DIGLUCONATE SOLUTION (20% W/V) PH.EUR.

Available from:

G & A Licensing Limited

INN (International Name):

PHENOL CHLORHEXIDINE DIGLUCONATE (AS CHLORHEXIDINE DIGLUCONATE SOLUTION (20% W/V) PH.EUR.

Dosage:

1.2/0.25 %w/w

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Authorization status:

Withdrawn

Authorization date:

2011-03-02

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)
PPA1447/048/001
Case No: 2068999
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
G & A LICENSING LTD
BALLYMURRAY, CO. ROSCOMMON, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
GERMOLENE FIRST AID 1.2% W/W / 0.25 % W/W CREAM
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 16/10/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/10/2009_
_CRN 2068999_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Germolene First Aid 1.2% w/w / 0.25 % w/w Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenol 1.20% w/w and Chlorhexidine Digluconate Solution to give Chlorhexidine Digluconate 0.25% w/w
Also contains cetostearyl alcohol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
_Product imported from the UK:_
A pink, viscous, homogeneous cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of minor skin irritations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply as necessary after cleansing for up to 3 days.
4.3 CONTRAINDICATIONS
Known hypersensitivity to any of the constitue