UREA 40 PERCENT- urea cream
Bryant Ranch Prepack
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.
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Urea 40 Percent Cream
DESCRIPTION:
INGREDIENTS: Each gram
of Urea Cream 40%
contains Urea 40% and the
following inactive
ingredients: Carbomer,
Cetearyl Alcohol, Glycerin,
Glyceryl Stearate SE,
Mineral Oil, Purified Water,
White Petrolatum.
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 of the skin.
INDICATIONS:
This product is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
CONTRAINDICATIONS:
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
WARNINGS:
FOREXTERNALUSEONLY.NOTFOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN.
Avoid contact with eyes, lips and mucous membranes.
General:
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.
Information for Patients:
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.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
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.
Pregnancy:
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.
ADVERSE REACTIONS:
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
DOSAGE AND ADMINISTRATION:
Use as
directed by your physician.
See label booklet for full
Prescribing Information.
STORAGE:
Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.
| 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 |
|---|---|---|---|
| Bryant Ranch Prepack | 171714327 | REPACK(63629-9266) , RELABEL(63629-9266) | |