Urea emulsion

1 indications and usage

Urea 45% Emulsionis 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% Emulsionto 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% Emulsionshould 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% Emulsionis administered to a nursing mother.

11 description

Urea 45% Emulsionis a white emollient topical preparation. Each milliliter of Urea 45% Emulsioncontains 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:

Urea

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% Emulsionis 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 (59-86F).
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:
Rivers Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 02/10 488-10

Ingredients and appearance - Product information

Urea emulsion- Urea

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 68032-488
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Urea ( UNII: 8W8T17847W)( Urea - UNII: 8W8T17847W ) 450 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Propylene glycol ( UNII: 6DC9Q167V3)
Medium-chain triglycerides ( UNII: C9H2L21V7U)
Polyethylene glycol 300 ( UNII: 5655G9Y8AQ)
Water ( UNII: 059QF0KO0R)
Trolamine ( UNII: 9O3K93S3TK)
Alpha-tocopherol acetate ( UNII: 9E8X80D2L0)
Lactic acid ( UNII: 33X04XA5AT)
Glycerin ( UNII: PDC6A3C0OX)
Polysorbate 60 ( UNII: CAL22UVI4M)
Linoleic acid ( UNII: 9KJL21T0QJ)
Sorbitan monostearate ( UNII: NVZ4I0H58X)
Zinc undecylenate ( UNII: 388VZ25DUR)
Titanium dioxide ( UNII: 15FIX9V2JP)
Cetyl alcohol ( UNII: 936JST6JCN)
Edetate disodium ( UNII: 7FLD91C86K)
Hydroxyethyl cellulose (140 cps at 5%) ( UNII: 8136Y38GY5)
Xanthan gum ( UNII: TTV12P4NEE)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
unapproved drug other USA

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

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 RIVERS 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 (59-86F).
Protect from freezing.

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