UREA by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.
Rx Only
For external use only. Not for ophthalmic use.
Description
Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide.
Urea is a diamide of carbonic acid with the following chemical structure:
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, ingrown and devitalized nails.
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, Urea 40% should be given to a pregnant woman only if clearly needed.
Urea Lotion 40% Cream 8 oz. (226.8g): NDC: 63629-2040-1
Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504
UREA
urea lotion |
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Labeler - Bryant Ranch Prepack (171714327) |
Registrant - Bryant Ranch Prepack (171714327) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Bryant Ranch Prepack | 171714327 | REPACK(63629-2040) , RELABEL(63629-2040) |