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IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0979/005/001
Case No: 2032524
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants
to
RECKITT BENCKISER IRELAND LTD
7 RIVERWALK, CITYWEST BUSINESS CAMPUS, DUBLIN 24, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
DETTOL FRESH 4% W/V CONCENTRATE FOR CUTANEOUS SOLUTION
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 06/02/2007 until 24/11/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/04/2007_
_CRN 2032524_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dettol Fresh 4 %w/v Concentrate for Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Benzalkonium chloride 4.0 %w/v.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for Cutaneous solution
A clear, colourless concentrate for cutaneous solution with a characteristic lemon/pine odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for prophylaxis of topical infection in intact and abraded skin and for skin preparation
prior to surgical or diagnostic procedure.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration – topical to relevant areas.
D
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