Urea 40% by is a Prescription medication manufactured, distributed, or labeled by Patrin Pharma, Inc. Drug facts, warnings, and ingredients follow.
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.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
This product 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 and consult a physician.
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed.
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
28.35 g (1 oz.) bottles, NDC: 39328-019-01
85 g (3 oz.) bottles, NDC: 39328-019-03
198.4 g (7 oz.) bottles, NDC: 39328-019-07
NDC: 39328-019-01
Urea 40%
Topical Cream
For External Use Only
Not for Ophthalmic Use
Rx Only
Net Wt.
28.35 g (1 oz.)
PATRIN
PHARMA
UREA 40%
urea cream |
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Labeler - Patrin Pharma, Inc (806841677) |