DETTOL ANTISEPTIC
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-05-2024
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Active ingredient:
CHLOROXYLENOL TRICLOSAN EDETATE POTASSIUM
Available from:
Reckitt Benckiser Ireland Ltd
Dosage:
0.3/0.3/0.2 %w/w
Pharmaceutical form:
Cream
Authorization date:
1998-10-23
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)
PA0979/004/001
Case No: 2051147
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 ANTISEPTIC CREAM CHLOROXYLENOL 0.3%W/W TRICLOSAN 0.3%W/W EDETIC ACID 0.2%W/W
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 23/10/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 13/01/2009_
_CRN 2051147_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dettol Antiseptic Cream
Chloroxylenol 0.3% w/w
Triclosan 0.3% w/w
Edetic Acid 0.2% w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains Cetostearyl Alcohol (a constituent of Emulsifying Wax)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white, water-miscible cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for the topical treatment of skin injuries.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For the topical application to the skin.
Adults and children: After thorough cleansing, apply in small amounts di
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