The following Structured Product Label (SPL) was submitted to the FDA by Method Pharmaceuticals, Llc for the product Urea 40 Percent (NDC 58657-487). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description:, clinical pharmacology:, pharmacokinetics:, indications:, contraindications:, warnings:, general:, information for patients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Urea Is A Diamide Of Carbonic Acid With The Following Chemical Structure: (Urea 41 Percent Cream 01)
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.
The mechanism of action of topically applied urea is not yet known.
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.
This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
FOR EXTERNAL USE ONLY. NOT FOR 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.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Use as
directed by your physician.
See label booklet for full
Prescribing Information.
Store at room
temperature 15°C-30°C
(59°F-86°F).
Protect from freezing.
Keep bottle tightly closed.
This product is supplied in the following size(s): 3 oz, 1 oz, and 7oz
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 [email protected]; or call FDA at (800) FDA-1088.
Manufactured for:
Method Pharmaceuticals, LLC Fort Worth, Texas 76118
Rev. 11/21
Label (Urea1oz)
Label (Urea3oz)
Label (Urea7oz)
* Please review the disclaimer below.
