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----------Urea 45% Cream
1 INDICATIONS AND USAGE
Urea 45% Cream is indicated for the debridement and promotion of the normal healing of hyperkeratotic surface lesions, particularly where healing is delayed 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.
2 DOSAGE AND ADMINISTRATION
DIRECTIONS: Apply RIVER’S EDGE Urea 45% Cream to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.
5 WARNINGS AND PRECAUTIONS
KEEP OUT OF REACH OF CHILDREN.
6 ADVERSE REACTIONSTransient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
8 USE IN SPECIFIC POPULATIONS
8.1 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 reproduction studies are not always predictive of human response, Urea 45% Cream should be given to a pregnant woman only if clearly needed.
Urea 45% Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.
12 CLINICAL PHARMACOLOGYUrea 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 removal of devitalized nail plate tissue.
12.1 Pharmacokinetics: The mechanism of action of topically applied Urea is not yet known.
16 HOW SUPPLIED/STORAGE AND HANDLING16.1 Urea 45% Cream is supplied as follows:
SIZE: 9 oz. tube NDC #: 68032-429-09
16.2 Storage Conditions:
Store at controlled room temperature 15-30° C (59°-86°F).
Protect from freezing.
17 PATIENT COUNSELING INFORMATION17.1 GENERAL INFORMATION
Patients should be advised of the following:
• For external use only.
• Avoid contact with eyes, lips or mucous membranes.
• Temporary stinging, burning, itching, or irritation may occur and normally disappear on discontinuation of the medication.
*Sections or subsections omitted from the full prescribing information are not listed.
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 08/09 429-10
Revised: 12/2010 River's Edge Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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