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Urea Nail Gel

Pronunciation

Dosage Form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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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 LABEL Item Code (Source) NDC: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  
Packaging
# Item Code Package Description
1 NDC:51862-181-28 1 BOTTLE, GLASS (BOTTLE) in 1 CARTON
1 28 g in 1 BOTTLE, GLASS
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: 12/2011
 
Libertas Pharma, Inc.



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