Label: URAMAXIN- urea cream
- NDC Code(s): 43538-210-09
- Packager: Medimetriks Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
Updated March 25, 2011
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- SPL UNCLASSIFIED SECTION
In a vehicle containing Menthol, Camphor and Eucalyptus Oil
For external use only. Not for ophthalmic use.Close
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:
- CLINICAL PHARMACOLOGY
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.Close
- 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.Close
Known hypersensitivity to any of the listed ingredients.Close
For external use only. Avoid contact with eyes, lips or mucous membranes.Close
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.
- ADVERSE REACTIONS
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.Close
- 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.Close
- HOW SUPPLIED
Uramaxin® (45% Urea) CreamClose
9 oz. tube, NDC 43538-210-09
- SPL UNCLASSIFIED SECTION
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)
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-210 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength urea (UNII: 8W8T17847W) (urea - UNII:8W8T17847W) urea 450 mg in 1 g Inactive Ingredients Ingredient Name Strength camphor (synthetic) (UNII: 5TJD82A1ET) edetate disodium (UNII: 7FLD91C86K) eucalyptus oil (UNII: 2R04ONI662) menthol (UNII: L7T10EIP3A) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43538-210-09 1 in 1 CARTON 1 255 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 01/01/2009 Labeler - Medimetriks Pharmaceuticals, Inc. (019903816) Establishment Name Address ID/FEI Business Operations Groupe Parima 252437850 MANUFACTURE