Oilatum Cream

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Liquid paraffin light; White soft paraffin

Commercializzato da:

GlaxoSmithKline Consumer Healthcare (Ireland) Limited

Codice ATC:

D02AC

INN (Nome Internazionale):

Liquid paraffin light; White soft paraffin

Dosaggio:

6.0 %w/w +15.0 percent weight/weight

Forma farmaceutica:

Cream

Tipo di ricetta:

Product not subject to medical prescription

Area terapeutica:

Soft paraffin and fat products

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

2003-03-07

Scheda tecnica

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.
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