AIDEX FIRST AID ANTISEPTIC
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
AMINOACRIDINE HYDROCHLORIDE BENZOCAINE PHENOXYETHANOL
Available from:
Ovelle Limited
Dosage:
0.1,0.1,1 %w/w
Pharmaceutical form:
Cream
Authorization date:
1993-02-11
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)
PA0206/029/001
Case No: 2043901
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
OVELLE LIMITED
DUNDALK INDUSTRIAL ESTATE, COE'S ROAD, DUNDALK, CO. LOUTH, IRELAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
AIDEX FIRST AID ANTISEPTIC CREAM, AMINOACRIDINE HYDROCHLORIDE 0.1% W/W, BENZOCAINE 0.1% W/W, PHENOXYETHANOL 1.0% 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 11/02/2008.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/04/2008_
_CRN 2043901_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aidex First Aid Antiseptic Cream
Aminoacridine Hydrochloride 0.1% w/w,
Benzocaine 0.1% w/w,
Phenoxyethanol 1.0% w/w.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aminoacridine Hydrochloride 0.1 % w/w,
Benzocaine 0.1 % w/w,
Phenoxyethanol 1.0 % w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
A pale yellow cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aidex Cream is a cream for the symptomatic treatment of minor abrasions and scalds.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Aidex Cream is appl
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