1 INDICATIONS AND USAGE

Urea 45% Emulsion is indicated for use in the topical treatment for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses.

2 DOSAGE AND ADMINISTRATION

Apply Urea 45% Emulsion to affected skin area(s) twice per day, or as directed by a physician. Rub in until completely absorbed.

3 DOSAGE FORM AND STRENGTH

45% urea/mL emulsion

4 CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

5 WARNINGS AND PRECAUTIONS

KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.
• For external use only. Not for ophthalmic use.
• Avoid contact with eyes, lips, or mucous membranes.
• If redness or irritation occurs, discontinue use.
• Use this medication only as directed by a physician. It should not be used to treat any condition other than that for which it was prescribed.
• If swallowed seek medical attention or contact a Poison Control Center immediately.

6 ADVERSE REACTIONS

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Call your doctor for medical advice about side effects.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy
Pregnancy Category B: Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Urea 45% Emulsion should be given to a pregnant woman only if clearly needed.

8.3 Nursing Mothers
It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 45% Emulsion is administered to a nursing mother.

11 DESCRIPTION

Urea 45% Emulsion is a white emollient topical preparation. Each milliliter of Urea 45% Emulsion contains 45% urea USP. Inactive ingredients: propylene glycol, caprylic/capric triglycerides, PEG-6, purified water, trolamine, vitamin E acetate, lactic acid, glycerin, polysorbate-60, linoleic acid, sorbitan monostearate, zinc undecylenate, titanium dioxide, cetyl alcohol, EDTA disodium, hydroxyethyl cellulose, and xanthan gum.

Urea is a diamide of carbonic acid with the following chemical structure:

12 CLINICAL PHARMACOLOGY

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.

12.1 Pharmacokinetics
The mechanism of action of topically applied urea is not yet known.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied
Urea 45% Emulsion is a white topical preparation, supplied in 240 mL bottles, NDC 68032-488-24

16.2 Storage and Handling
Store at controlled room temperature 15-30° C (59°-86°F).
Protect from freezing.

17 PATIENT COUNSELING INFORMATION

Patients should be advised of the following:
• For external use only. Not for ophthalmic use.
• Avoid contact with eyes, lips, or mucous membranes.
• Temporary stinging, burning, itching, or irritation may occur and normally disappear on discontinuation of the medication.
• This medication is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed.
• If swallowed seek medical attention or contact a Poison Control Center immediately.

*Sections or subsections omitted from the full prescribing information are not listed.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 02/10 488-10

PACKAGING

NDC 68032-488-24

Urea 45% Emulsion

In a vehicle containing zinc undecylenate and lactic acid

For external use only.
Not for ophthalmic use.

240 mL

Ingredients: Each milliliter of Urea 45% Emulsion contains 45% urea USP.

Inactive ingredients: propylene glycol, caprylic/capric triglycerides, PEG-6, purified water, trolamine, vitamin E acetate, lactic acid, glycerin, polysorbate-60, linoleic acid, sorbitan monostearate, zinc undecylenate, titanium dioxide, cetyl alcohol, EDTA disodium, hydroxyethyl cellulose, and xanthan gum.

Directions: Apply RIVER’S EDGE UREA 45% EMULSION to affected skin area(s) twice a day or as directed by a physician. Rub in until completely absorbed.
See package insert for full instructions and prescribing informaiton.

USE ONLY AS DIRECTED BY A PHYSICIAN.
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at controlled room temperature 15-30° C (59°-86°F).
Protect from freezing.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 02/10 488-20

UREA
urea emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	68032-488
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UREA)	UREA	45 in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
POLYETHYLENE GLYCOL 300
WATER
TROLAMINE
ALPHA-TOCOPHEROL ACETATE
LACTIC ACID
GLYCERIN
POLYSORBATE 60
LINOLEIC ACID
SORBITAN MONOSTEARATE
ZINC UNDECYLENATE
TITANIUM DIOXIDE
CETYL ALCOHOL
EDETATE DISODIUM
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)
XANTHAN GUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	68032-488-24	240 mL In 1 BOTTLE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		03/03/2010

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 02/2010River's Edge Pharmaceuticals, LLC