UREA- urea gel 
Mayne Pharma Inc.

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.

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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.

Carton

UREA 
urea gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51862-181
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51862-181-281 in 1 CARTON10/28/201103/31/2019
128 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER10/28/201103/31/2019
Labeler - Mayne Pharma Inc. (867220261)

Revised: 7/2017
Document Id: 16eb680b-fd40-44fd-a115-41a868e7f03e
Set id: 5ad3c07b-fee0-44e8-810e-dbfc6abac9ee
Version: 3
Effective Time: 20170728
 
Mayne Pharma Inc.