NDC Code(s) : 42808-200-05, 42808-200-09
Packager : Exact-Rx, 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:42808-200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA(UNII: 8W8T17847W)
(UREA - UNII:8W8T17847W) 		UREA500 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER COPOLYMER TYPE A(UNII: 71DD5V995L)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
LACTIC ACID(UNII: 33X04XA5AT)
MINERAL OIL(UNII: T5L8T28FGP)
POLYSORBATE 85(UNII: A7F3N56197)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
STEARIC ACID(UNII: 4ELV7Z65AP)
PYRITHIONE ZINC(UNII: R953O2RHZ5)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42808-200-051 in 1 CARTON 08/01/2011
1142 g in 1 TUBE Type 0: Not a Combination Product
2NDC:42808-200-091 in 1 CARTON 08/01/2011
2255 g in 1 TUBE Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2011 09/30/2018

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0200-05        Rx Only

Urea
(50% Urea in a Cream Base)

50%

CREAM

Exact-Rx.
INCORPORATED

Net Wt. 5 oz (142 g)

Carton