UREA

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.

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
(click image for full-size original)
UREA
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC: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 AT 1%)
MENTHOL, UNSPECIFIED FORM
WATER
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC: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 07/31/2018
Labeler — Mayne Pharma Inc. (867220261)

Revised: 07/2017 Mayne Pharma Inc.

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