STIEFEL DRY SKIN 21 %w/w Cream

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

ARACHIS OIL

Available from:

Stiefel Laboratories (U.K.) Ltd.

INN (International Name):

ARACHIS OIL

Dosage:

21 %w/w

Pharmaceutical form:

Cream

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Withdrawn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 Dry Skin Cream
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Arachis Oil 21.0 % w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Cream
A white homogeneous oil-in-water cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
To reduce moisture loss from the epidermis and restore resilience to and protection against external factors in the
treatment of dry, sensitive skin, lanolin sensitivity, alkali intolerance, ichthyosis and similar conditions.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Stiefel Dry Skin Cream may be used as often as required. Apply to the affected areas and rub in well.
It is especially effective after washing when the normal acid condition of the skin may be disturbed and when the
sebum content of the stratum corneum may be depleted.
4.3 CONTRAINDICATIONS
Known hypersensitivity to the ingredients.
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 is no restriction 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 14/12/2006_
_CRN 2031212_
_page number: 1_
4.8 UNDESIRABLE EFFECTS
None.
4.9 OVERDOSE
Not applicable.
5 PHARMACOLOGICAL PROPERTIES
5.1 PHARMACODYNAMIC PROPERTIES
Arachis Oil exerts an emollient effect by forming an occlusive film which reduces trans-epidermal water loss, thus
restoring normal skin humidity levels.
5.2 PHARMACOKINETIC PROPERTIES
Not applicable.
5.3 PRECLINICAL SAFETY DATA
Not applicable.
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Povidone
Propylene Glyc