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Urea

Libertas Pharma, Inc.

Rx Only 45% Urea Nail Gel In a vehicle containing Camphor, Eucalyptus Oil and Menthol )


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

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 450 mg

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 Marketing Start Date Marketing End Date
1 28 in 1 BOTTLE, GLASS
2 NDC:51862-181-28 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-10-28


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Be sure to consult your doctor before taking any medication!
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