ACNECIDE WASH
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
27-04-2024
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Active ingredient:
BENZOYL PEROXIDE HYDROUS
Available from:
Galderma (UK) Ltd
Dosage:
10 %w/w
Pharmaceutical form:
Gel
Authorization date:
1997-10-31
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)
PA0590/007/004
Case No: 2036964
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
GALDERMA (UK) LTD
MERIDIEN HOUSE, 69-71 CLARENDON ROAD, WATFORD, HERTS WD17 1DS, UNITED KINGDOM
an authorisation, subject to the provisions of the said Regulations, in respect of the product
ACNECIDE WASH 10% W/W GEL
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 31/10/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/11/2007_
_CRN 2036964_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Acnecide Wash 10 % w/w Gel
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydrous Benzoyl Peroxide equivalent to Benzoyl peroxide 10 % w/w.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Gel.
White to off white gel.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Acnecide Wash is intended for the cutaneous treatment of acne vulgaris of the face, chest and back, where comedones,
papules predominate.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous (topical) administration only.
Unless otherwise directed, Acnecide Wash should be applied once daily to cover the affected skin ar
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