Dosage Form: cream
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.
ASCEND Laboratories, LLC
Urea 39% Cream
Urea Cream Description
Urea 39% cream is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.
Each gram contains 39% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax, glycerin, isopropyl myristate, purified water, sorbitol, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.
Urea is diamide of Carbonic acid with the following structure:
Urea Cream - Clinical Pharmacology
Urea Cream gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.
The exact mechanism of action of topically applied urea is not known.
Indications and Usage for Urea Cream
Urea 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.
Known hypersensitivity to any of the listed ingredients
For external use only. Avoid contact with eyes, lips or mucous membranes.
Urea Cream should be used as directed by a physician and should not be used to treat conditions other than those for which it was prescribed. If redness or irritation occurs, discontinue use.
Pregnancy: Category C
Animal reproduction studies have not been conducted with Urea Cream. It is also not known whether Urea Cream can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea Cream should be given to a pregnant woman only if clearly needed.
It is not known whether Urea Cream is excreted in human milk, therefore caution should be exercised when administering to a nursing mother.
Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.
Urea Cream Dosage and Administration
Apply to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN
How is Urea Cream Supplied
Urea 39% Cream is supplied in
227g NDC 67877-305-12
Store at 20-25°C (68-77°F)
[see USP controlled room temperature].
Protect from freezing.
Manufactured for: Manufactured by:
Ascend Laboratories, LLC Crown Laboratories, Inc
Montvale, NJ 07645 Johnson City, TN 37604
For Topical Use
NET WT 8 oz
|Labeler - Ascend Laboratories, LLC (141250469)|
|Crown Laboratories, Inc.||079035945||manufacture(67877-305)|