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UREA SOLUTION 50%
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50% Urea Pre-filled applicator contains a keratolytic solution, which is a gentle, yet potent, tissue softener for nails and skin. Each mL contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, disodium EDTA, hydroxyethylcellulose, lactic acid, PEG-6, polysorbate 60, propylene glycol, purified water sorbitan stearate, titanium dioxide, triethanolamine, urea, vitamin E, xanthan gum and zinc undecylenate.
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.
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 pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, devitalized, and ingrown nails.
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, 50% Urea solution should be given to a pregnant woman only if clearly needed.
NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Urea solution is administered to a nursing woman.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
DOSAGE AND ADMINISTRATION
Apply 50% Urea solution to diseased or damaged nail tissue twice per day, or as directed by a physician.
50% Urea Pre-filled applicator
NDC 0168-0644-12, is supplied in a carton containing 1 -12 mL applicator.
Store at controlled room temperature 15˚- 30˚C (59˚-86˚F).
Protect from freezing.
HOW TO USE
Please see reverse side for full Prescribing Information.
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 12 ML LABEL
FOR EXTERNAL USE ONLY. AVOID CONTACT
DIRECTIONS: Apply 50% Urea solution to diseased or damaged nail or skin tissue twice a day, or as directed by a physician.
Mfd for: E. FOUGERA & CO.,
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 12 ML CARTON
FOR EXTERNAL USE ONLY.
E. FOUGERA & CO.
Revised: 09/2009 E. FOUGERA & CO. A division of Nycomed US Inc.
Reproduced with permission of U.S. National Library of Medicine
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