Urea 40 Percent by is a Prescription medication manufactured, distributed, or labeled by Bryant Ranch Prepack. Drug facts, warnings, and ingredients follow.
FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
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 to date. Studies on reproduction and fertility also have not been performed.
Category C. 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.
This product is supplied in the following size: 1 oz NDC: 63629-9265-1
To report a serious adverse event or obtain product information, call 877-250-3427
To report a serious adverse event, please contact Method Pharmaceuticals at (877) 250-3427; email at contact@methodpharm.com; or call FDA at (800) FDA-1088.
UREA 40 PERCENT
urea cream |
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Labeler - Bryant Ranch Prepack (171714327) |
Registrant - Bryant Ranch Prepack (171714327) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Bryant Ranch Prepack | 171714327 | REPACK(63629-9265) , RELABEL(63629-9265) |