Urea

Ascend Laboratories, LLC

FULL PRESCRIBING INFORMATION: CONTENTS*

• UREA DESCRIPTION
• CLINICAL PHARMACOLOGY
• PHARMACOKINETICS
• UREA INDICATIONS AND USAGE
• UREA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• Pregnancy: Category C
• Nursing Mothers
• UREA ADVERSE REACTIONS
• UREA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED

FULL PRESCRIBING INFORMATION

ASCEND Laboratories, LLC

Urea 39% Cream

RX ONLY

UREA 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.

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.

UREA INDICATIONS 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 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.

UREA ADVERSE REACTIONS

Transient stinging, burning, itching or irritation is possible and normally resolves upon discontinuing the medication.

UREA 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 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

                                                                                          P6168.00

ASCEND
Laboratories, LLC

NDC 67877-305-12

Urea
Cream
39%

For Topical Use

Only

Rx Only

NET WT 8 oz

(227g)