UREA- urea emulsion
Exact-Rx, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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(50% Urea) In a zinc undecylenate and lactic acid vehicle
For external use only. Not for ophthalmic use. Do not use on eyes, lips or mucous membranes.
DESCRIPTION: Urea Emulsion 50% contains a keratolytic solution, which is gentle, yet potent, tissue softener for nails and dry rough skin. Urea Emulsion 50% contains 50% urea along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocopheryl acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.
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 while shedding scaly skin at regular intervals, which then softens the 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 hyper-keratotic conditions such as dry, rough skin, dermatitis, psoriasis, ichthyosis, keratoderma, eczema, keratosis pilaris, keratosis palmaris, xerosis, 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 reproduction studies are not always predictive of human response, Urea Emulsion 50% should be given to a pregnant woman only if clearly needed.
UREA
urea emulsion |
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Labeler - Exact-Rx, Inc. (137953498) |