Generic Name: urea
Dosage Form: lotion
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.
Urea Cream, 40% Urea Lotion, 40% Urea Gel, 40%
Urea Lotion Description
Urea, 40% is a keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream, 40% and Urea Lotion, 40% contains 40% urea, carbomer 940, cetyl alcohol, glyceryl monostearate, mineral oil, propylene glycol, purified water, trolamine, white petrolatum, and xanthan gum. Each gram of Urea Gel, 40% contains 40% urea, edetate disodium dihydrate, glycerin, hydroxethylcellulose, PEG-6 caprylic/capric glyceride, purified water, and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:
Urea Lotion - 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 Usage for Urea Lotion
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.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Urea Lotion Dosage and Administration
Apply Urea 40% 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.
How is Urea Lotion Supplied
Urea Cream, 40% is available as follows:
28.35 g tube (NDC 45802-170-03)
85 g tube (NDC 45802-170-53)
198.6 g tube (NDC 45802-170-77)
Urea Lotion, 40% is available as follows:
8 FL OZ (236.6 mL) bottle (NDC 45802-176-55)
Urea Gel, 40% is available as follows:
0.5 FL OZ (15 mL) bottle (NDC 45802-171-56)
|Labeler - Perrigo New York Inc (078846912)|
|Registrant - L Perrigo Compnay (006013346)|
|Perrigo New York Inc||078846912||MANUFACTURE|