Urea Nail Gel

Rx Only

45% Urea Nail Gel

In a vehicle containing Camphor, Eucalyptus Oil and Menthol )

FOR TOPICAL USE ONLY

28 mL Bottle

with Applicator Brush

Directions:

Apply LIBERTAS PHARMA INC.'s 45% Urea Nail Gel to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

FOR EXTERNAL USE ONLY.

NOT FOR OPHTHALMIC USE.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed seek medical attention or contact a Poison Control Center immediately.

USE ONLY AS DIRECTED BY A PHYSICIAN.

CAUTION: If redness or irritation occurs, discontinue use. Avoid contact with eyes.

Ingredients:

Each gram of Libertas Pharma Inc.'s 45% Urea Nail Gel contains 45% Urea. Other ingredients include: Camphor, Disodium EDTA, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Propylene Glycol, and Purified Water.

PLEASE SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

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

Manufactured for:

Libertas Pharma Inc.

Lawrenceville, GA 30043

Rev. 7/11   181-28

PRINCIPAL DISPLAY PANEL

NDC 51862-181-28

Rx Only

45% Urea Nail Gel

In a vehicle containing Camphor, Eucalyptus Oil and Menthol

FOR TOPICAL USE ONLY

28 mL Bottle

with Applicator Brush

Libertas Pharma, Inc.

UREA  urea  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-181 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 450 mg  in 1 g

Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC)   EDETATE DISODIUM   EUCALYPTUS OIL   HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)   MENTHOL   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51862-181-28 1 BOTTLE In 1 CARTON contains a BOTTLE, GLASS 1 28 g In 1 BOTTLE, GLASS This package is contained within the CARTON (51862-181-28)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/28/2011

Labeler - Libertas Pharma, Inc. (962128943)

Revised: 12/2011Libertas Pharma, Inc.