NDC Code(s) : 51862-182-16
Packager : Mayne Pharma Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

UREAUREA 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(UNII: 8W8T17847W)
(UREA - UNII:8W8T17847W) 		UREA450 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1NDC:51862-182-161 in 1 CARTON 10/07/2011
1454 g in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 10/07/2011 07/31/2018

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