EUCERIN INTENSIVE 10% W/W UREA TREATMENT CREAM

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

UREA

Available from:

Beiersdorf UK Limited

ATC code:

D02AX

INN (International Name):

UREA

Dosage:

10 %w/w

Pharmaceutical form:

Cream

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other emollients and protectives

Authorization status:

Marketed

Authorization date:

2004-09-24

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Eucerin Intensive 10% w/w Urea Treatment Cream.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Urea 10% w/w
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cream.
White, shiny cream.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of ichthyosis, xeroderma, hyperkeratosis and other
chronic dry skin conditions such as atopic eczema
(dermatitis).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Eucerin Intensive 10% w/w Urea Treatment Cream should be applied
sparingly twice daily to the affected areas of skin
and rubbed in.
It should not be allowed to come into contact with the eyes or
mucosae.
It should not be applied on
large areas in patients with renal insufficiency.
The duration of use depends on the particular condition of the skin
and should be established on an individual basis.
4.3 CONTRAINDICATIONS
Eucerin Intensive 10% w/w Urea Treatment Cream should not be used in
patients with a known hypersensitivity to any
of the ingredients.
It should not be used to treat excoriated acute inflammation of the
skin.
It should not be used on
large areas in patients with renal insufficiency.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A doctor should be consulted if symptoms persist.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTION
Urea may potentiate the release of active substances from topical
preparations and their penetration into the skin.
This
is known in particular for corticosteroids, dithranol and
fluorouracil.
4.6 FERTILITY, PREGNANCY AND LACTATION
There are no known risks.
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
No effects would be anticipated.
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