ITCH RELIEF %w/w Cream
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
07-06-2024
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Virkt innihaldsefni:
LAUROMACROGOL 400 UREA
Fáanlegur frá:
Reckitt Benckiser Ireland Ltd
INN (Alþjóðlegt nafn):
LAUROMACROGOL 400 UREA
Skammtar:
%w/w
Lyfjaform:
Cream
Gerð lyfseðils:
Product not subject to medical prescription
Leyfisstaða:
Withdrawn
Leyfisdagur:
2012-08-27
Vara einkenni
IRISH MEDICINES BOARD ACT 1995, AS AMENDED
MEDICINAL PRODUCTS (CONTROL OF PLACING ON THE MARKET) REGULATIONS, 2007, AS AMENDED
PA0979/044/001
Case No: 2084633
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
ITCH RELIEF CREAM LAUROMACROGOLS 3.0% W/W UREA 5.0% W/W
the particulars of which are set out in 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 27/08/2010.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/08/2010_
_CRN 2084633_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Itch Relief Cream
Lauromacrogols 3.0 % w/w
Urea 5.0 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cream
A white smooth cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of pruritus, eczema, dermatitis, and scaling skin conditions where an antipruritic and/or hydrating
effect is required. It may also be used for the continued treatment and follow-up treatment of these skin diseases.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children: Itch Relief Cream should be applied to each affected area twice a day.
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