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UREA

Libertas Pharma, Inc.

Rx Only 45% Urea Lotion


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

UREA

UREA

UREA CREAM

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:51862-182
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
ALCOHOL
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)
MENTHOL
water
titanium dioxide

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 454 in 1 BOTTLE
2 NDC:51862-182-16 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2011-10-07


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Be sure to consult your doctor before taking any medication!
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