NDC Code(s) : 0259-1139-80
Packager : Merz Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AluveaUrea CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0259-1139
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea(UNII: 8W8T17847W)
(Urea - UNII:8W8T17847W) 		Urea39 g in 100 g
Inactive Ingredients
Ingredient Name Strength
Dimethyl isosorbide(UNII: SA6A6V432S)
Glycerin(UNII: PDC6A3C0OX)
Isopropyl Myristate(UNII: 0RE8K4LNJS)
Sorbitol(UNII: 506T60A25R)
Tridecyl Stearate(UNII: A8OE252M6L)
Neopentyl Glycol Dicaprate(UNII: 77T908SE82)
Tridecyl Trimellitate(UNII: FY36J270ES)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0259-1139-801 in 1 CARTON
1227 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 04/15/2011

PRINCIPAL DISPLAY PANEL

NDC 0259-1139-80

ALUVEA ™
39% Urea Cream

WITH UNIQUE
CSP ™
VEHICLE
TECHNOLOGY

FOR EXTERNAL USE ONLY

8 oz. (227g)

Rx ONLY

Principal Display Panel - 227g Carton