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----------Urea 40 Gel/Lotion
DESCRIPTION:Urea 40 Gel/Lotion is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and/or skin.
Each gram of Urea 40 Lotion contains 40% Urea, carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, triethanolamine and xanthan gum.
Each gram of Urea 40 Gel contains 40% Urea, caprylic/capric glycerides, disodium EDTA, glycerin, PEG-6 hydroxyethylcellulose, water, xanthan gum. 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 prurient 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, ingrown and devitalized 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 Category C. Animal reproduction studies have not been conducted with Urea 40 Gel/Lotion. It is also now known whether Urea 40 Gel/Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 40 Gel/Lotion 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 Urea 40 Gel/Lotion is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
DOSAGE AND ADMINISTRATION:
Apply Urea 40 Gel/Lotion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.
Urea 40 Gel or Lotion supplied as a:
Revised: 03/2011 Kylemore Pharmaceuticals, LLC
Reproduced with permission of U.S. National Library of Medicine
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