EURAX HC
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
CROTAMITON HYDROCORTISONE
Available from:
Novartis Consumer Health UK Limited
Dosage:
10/0.25 %w/w
Pharmaceutical form:
Cream
Authorization date:
1997-09-05
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)
PA0030/018/001
Case No: 2061350
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
NOVARTIS CONSUMER HEALTH UK LTD
WIMBLEHURST ROAD, HORSHAM, WEST SUSSEX RH12 5AB, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
EURAX HC 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 12/06/2009.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 12/06/2009_
_CRN 2061350_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eurax Hc Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Crotamiton 10% w/w and Hydrocortisone 0.25% w/w.
Excipients: also includes stearyl alcohol 25% w/w; propylene glycol 20% w/w; methyl hydroxybenzoate (E218)
0.025% w/w and propyl hydroxybenzoate (E216) 0.015% w/w.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white to cream coloured cream with an odour characteristic of the perfume.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Irritant contact dermatitis, allergic contact dermatitis, insect bite reactions, mild to moderate eczema.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For extern
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