UREA- urea cream 
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 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.

45% Urea Lotion

UREA 
urea cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51862-182
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)  
ALCOHOL (UNII: 3K9958V90M)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51862-182-161 in 1 CARTON10/07/201107/31/2018
1454 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other10/07/201107/31/2018
Labeler - Mayne Pharma Inc. (867220261)

Revised: 7/2017
 
Mayne Pharma Inc.