Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
Liquid paraffin light; White soft paraffin
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D02AC
Liquid paraffin light; White soft paraffin
6.0 %w/w +15.0 percent weight/weight
Cream
Product not subject to medical prescription
Soft paraffin and fat products
Not marketed
2003-03-07
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Oilatum Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Contains Light Liquid Paraffin 6.0% w/w and White Soft Paraffin 15.0% w/w in a cream base. Also contains cetostearyl alcohol and potassium sorbate. For a full list of excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Cream. A white to off white cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oilatum Cream is indicated in the treatment of contact dermatitis, atopic eczema, senile pruritus, ichthyosis and related dry skin conditions. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Oilatum Cream may be used as often as required. Apply to the affected area and rub in well. It is especially effective after washing, when the sebum content of the stratum corneum may be depleted resulting in excessive moisture loss. Oilatum Cream is suitable for use in adults, children and the elderly. 4.3 CONTRAINDICATIONS Should not be used in patients with known hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Oilatum Cream should be used with caution in patients with a known sensitivity or allergy to white soft paraffin or light liquid paraffin or to any of the excipients in the preparation. Cetostearyl alcohol and potassium sorbate may cause local skin reactions (e.g. contact dermatitis). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None. 4.6 FERTILITY, PREGNANCY AND LACTATION FERTILITY There are no data on the use of topical Oilatum Cream on human fertility. PREGNANCY There are no data on the use of topical Oilatum Cream in pregnant women. No effects during pregnancy are anticipated, since systemic exposure to white soft paraffin-light liquid paraffin is low. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Прочитайте повний документ