Urea

Ascend Laboratories, LLC

FULL PRESCRIBING INFORMATION

RX ONLY

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.

PHARMACOKINETICS
The exact mechanism of action of topically applied urea is not known.

Uses

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.

CONTRAINDICATIONS
Known hypersensitivity to any of the listed ingredients

WARNINGS
For external use only. Avoid contact with eyes, lips or mucous membranes.

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

PACKAGE LABEL - Urea Cream 40%

ASCEND
Laboratories, LLC

NDC 67877-272-21

Urea
Cream
40%

For Topical Use
Only

Rx Only

NET WT 1 oz
(28.35g)

PACKAGE LABEL - Urea Lotion 40%

ASCEND
Laboratories, LLC

NDC 67877-273-12

Urea
Lotion
40%

For Topical Use
Only

Rx Only

8 fl oz
(236.6ml)