[Ascend Laboratories, LLC]
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||unapproved drug other|
Urea cream, 40% is a keratolytic emollient, which is a gentle, yet effective, tissue softener for skin.
Each gram contains 40% Urea as the active ingredient, and the following inactive ingredients: dimethyl isosorbide, emulsifying wax NF, glycerin 99.7% USP, isopropyl myristate, purified water, sorbitol 70% Solution USP, tridecyl stearate and neopentyl glycol dicaprylate/dicaprate and tridecyl trimellitate.
Urea is diamide of Carbonic acid with the following structure:
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.
INDICATION AND USAGE
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.
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.
DOSAGE AND ADMINISTRATIONS
Apply to affected skin twice per day, or as directeded by your physician. Rub in until completely absorbed.
KEEP THIS AND ALL OTHER MEDICATIONS OUT OF REACH OF CHILDREN
Urea 40% cream is supplied in
28.35gm NDC 67877-272-21
85.05gm NDC 67877-272-03
198.6gm NDC 67877-272-07
Urea 40% lotion is supplied in
236.6ml NDC 67877-273-12
Store at room temperature 15°C -30°C (59°F-86°F).
Protect from freezing.
Manufactured for: Manufactured by:
Ascend Laboratories, LLC Crown Laboratories, Inc
Montvale, NJ 07645 Johnson City, TN 37604
PACKAGE LABEL - Urea Cream 40%
For Topical Use
NET WT 1 oz
|Labeler - Ascend Laboratories, LLC (141250469)|
|Crown Laboratories, Inc.||079035945||manufacture|