Urea Cream

Rx Only

45% Urea Lotion

Rx only

45% Urea

In a vehicle containing Camphor, Eucalyptus Oil and Menthol

FOR TOPICAL USE ONLY

Net Wt. 16 oz.

DIRECTIONS:

Apply 45% Urea Lotion to affected area(s). Rub in until lotion is completely absorbed. Use only as directed by a physician.

INGREDIENTS:

Each gram of 45% Urea Lotion contains 45% Urea in a formulation consisting of Camphor, Disodium EDTA, Alcohol SDA 40, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Water and Titanium Dioxide.

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.

For lot number and expiration date, see bottom of bottle.

Manufactured for:

Libertas Pharma, Inc.

Lawrenceville, GA 30043

Rev. 8/11    182-16

PRINCIPAL DISPLAY PANEL

NDC 51862-182-16

Rx Only

45% Urea

Lotion

45% Urea

In a vehicle containing

Camphor, Eucalyptus Oil

and Menthol

FOR TOPICAL USE ONLY

Net Wt. 16 oz.

Libertas

Pharma Inc.

UREA  urea  cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 51862-182 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   ALCOHOL   EUCALYPTUS OIL   HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)   MENTHOL   WATER   TITANIUM DIOXIDE

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 51862-182-16 1 BOTTLE In 1 CARTON contains a BOTTLE 1 454 g In 1 BOTTLE This package is contained within the CARTON (51862-182-16)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		10/07/2011

Labeler - Libertas Pharma, Inc. (962128943)

Revised: 12/2011Libertas Pharma, Inc.