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----------Uramaxin(45% Urea)GT PRE-FILLED APPLICATOR
1. Apply Uramaxin GT to affected nails or skin twice per day, or as directed by a physician.
DESCRIPTION:Uramaxin (45% Urea) GT is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin (45% Urea) GT contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.
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.
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.
PRECAUTIONS: 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: 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) GT should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: 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) GT is administered to a nursing woman.
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION: DIRECTIONS FOR NAILS: Apply Uramaxin (45% Urea) GT to diseased or damaged nail tissue twice per day, or as directed by a physician.
DIRECTIONS FOR SKIN: Apply Uramaxin (45% Urea) GT to affected area(s) twice per day, or as directed by a physician.
Store at controlled room temperature 15°-30°C (59°-86°F).
Revised: 07/2010 Medimetriks Pharmaceuticals, Inc.
Reproduced with permission of U.S. National Library of Medicine
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