STIEFEL EMOLLIENT 7.5 %w/w Soap
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
05-05-2024
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Active ingredient:
PARAFFIN, LIQUID
Available from:
Stiefel Laboratories (U.K.) Ltd.
INN (International Name):
PARAFFIN, LIQUID
Dosage:
7.5 %w/w
Pharmaceutical form:
Soap
Authorization status:
Withdrawn
Authorization date:
2009-05-08
Summary of Product characteristics
IRISH MEDICINES BOARD ACT 1995
MEDICINAL PRODUCTS(LICENSING AND SALE)REGULATIONS, 1998
(S.I. NO.142 OF 1998)
PA0144/044/001
Case No: 2029075
The Irish Medicines Board in exercise of the powers conferred on it by the above mentioned Regulations hereby grants to
STIEFEL LABS (U.K.) LTD.
HOLTSPUR LANE, WOOBURN GREEN, HIGH WYCOMBE, BUCKS HP10 0AU, ENGLAND
an authorisation, subject to the provisions of the said Regulations, in respect of the product
STIEFEL EMOLLIENT SOAP
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 25/02/2007.
Signed on behalf of the Irish Medicines Board this
________________
A person authorised in that behalf by the said Board.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/03/2007_
_CRN 2029075_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stiefel Emollient Soap
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Contains liquid paraffin
7.5 % w/w
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Medicated Soap
A salmon pink, oval soap bar.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Stiefel Emollient Soap is indicated as a gentle cleanser for dry sensitive skin. It is suitable for the treatment of diseases
where ordinary soaps have an adverse effect, such as pruritus, eczema and atopic dermatitis. The use of Stiefel
Emollient Soap in these conditions will cleanse, soothe and hydrate the skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Stiefel Emollie
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