Uramaxin (45% UREA) CREAM
FULL PRESCRIBING INFORMATION: CONTENTS*
- URAMAXIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USES
- URAMAXIN CONTRAINDICATIONS
- URAMAXIN ADVERSE REACTIONS
- URAMAXIN DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 255 g Carton
FULL PRESCRIBING INFORMATION
In a vehicle containing Menthol, Camphor and Eucalyptus Oil
For external use only. Not for ophthalmic use.
Uramaxin® (45% Urea) Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin® (45% Urea) Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.
Urea is a diamide of carbonic acid with the following chemical structure:
Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.
The mechanism of action of topically applied Urea is not yet known.
INDICATIONS AND USES
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.
Known hypersensitivity to any of the listed ingredients.
For external use only. Avoid contact with eyes, lips or mucous membranes.
This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
Pregnancy Category B
Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Uramaxin® (45% Urea) Cream should be given to a pregnant woman only if clearly needed.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Uramaxin® (45% Urea) Cream is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
URAMAXIN ADVERSE REACTIONS
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
URAMAXIN DOSAGE AND ADMINISTRATION
Apply Uramaxin® (45% Urea) Cream to affected skin twice per day, or as directed by a physician. Apply to diseased or damaged nails twice per day, or as directed by a physician.
Uramaxin® (45% Urea) Cream
9 oz. tube, NDC 43538-210-09
Store at controlled room temperature 15°-30° C (59°-86° F).
Protect from freezing.
363 Route 46 West
Fairfield, NJ 07004-2402 USA
Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA
PRINCIPAL DISPLAY PANEL - 255 g Carton
(45% UREA) CREAM
In a vehicle containing
and Eucalyptus Oil
FOR TOPICAL USE ONLY
Net Wt. 9 oz (255 g)