STIEFEL ACNE 6.37 Per Cent Soap

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SULPHONATED OIL MINERAL OIL EMULSION SORBITAN MONO-OLETAE

Available from:

Stiefel Laboratories (U.K.) Ltd.

INN (International Name):

SULPHONATED OIL MINERAL OIL EMULSION SORBITAN MONO-OLETAE

Dosage:

6.37 Per Cent

Pharmaceutical form:

Soap

Authorization status:

Withdrawn

Authorization date:

2009-05-08

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stiefel Acne Soap
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sulphonated surfactant blend 6.37% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Soap
An off-white oval-shaped, firm textured soap bar.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a detergent soap for cleansing of the skin in greasy and hyperkeratotic skin conditions, including acne vulgaris.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Make a lather with warm water and massage into the affected skin using the finger tips or a facecloth. Rinse and repeat
as necessary.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
None.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None.
4.6 PREGNANCY AND LACTATION
There are no restrictions on the use of the product during pregnancy or lactation.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None.
IRISH MEDICINES BOARD
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_Date Printed 07/12/2006_
_CRN 2030891_
_page number: 1_
4.8 UNDESIRABLE EFFECTS
None.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Stiefel Acne Soap is a detergent bar, comprising a blend of saponified high molecular weight fatty acids with
unsaponified sulphonated surfactant blend, which removes grease without irritating the skin. Stiefel Acne Soap
provides efficient cleansing in the management of acne and other skin conditions characterised by excess lipids,
follicular keratosis and degradation of the sebum.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Soap pellets
N-hydroxyethyl ethylenediamine triacetate so