NDC Code(s) : 43538-260-45
Packager : Medimetriks Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Uramaxin Urea CLOTH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-260
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)
EUCALYPTUS OIL(UNII: 2R04ONI662)
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) (UNII: ZYD53NBL45)
LEVOMENTHOL (UNII: BZ1R15MTK7)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:43538-260-4545 in 1 CARTON
115 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/07/2010

PRINCIPAL DISPLAY PANEL

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