UREA- urea cream
UREA- urea lotion
Ascend Laboratories, LLC
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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DESCRIPTION
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.
CHEMICAL STRUCTURE
Urea is diamide of Carbonic acid with the following structure:
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.
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.
PRECAUTIONS
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.
Nursing Mothers
It is not
known whether urea cream is excreted in human milk, therefore caution
should be exercised when administering to a nursing mother.
ADVERSE REACTIONS
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
HOW SUPPLIED
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
P1827.01
UREA
urea cream |
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UREA
urea lotion |
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Labeler - Ascend Laboratories, LLC (141250469) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Crown Laboratories, Inc. | 079035945 | manufacture(67877-272, 67877-273) |