NDC Code(s) : 42808-206-10
Packager : Exact-Rx, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

UREAUREA EMULSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42808-206
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)
CARBOMER HOMOPOLYMER TYPE C(UNII: 4Q93RCW27E)
CETYL ALCOHOL(UNII: 936JST6JCN)
EDETATE DISODIUM(UNII: 7FLD91C86K)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
GLYCERIN(UNII: PDC6A3C0OX)
LACTIC ACID(UNII: 33X04XA5AT)
LINOLEIC ACID(UNII: 9KJL21T0QJ)
MINERAL OIL(UNII: T5L8T28FGP)
PEG-6 STEARATE(UNII: 8LQC57C6B0)
POLYSORBATE 60(UNII: CAL22UVI4M)
WATER(UNII: 059QF0KO0R)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ZINC UNDECYLENATE(UNII: 388VZ25DUR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42808-206-101 in 1 CARTON
1284 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 08/01/2011

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0206-10        Rx Only

Urea
In a zinc undecylenate &
lactic acid vehicle

50%

EMULSION

Exact-Rx.
INCORPORATED

Net Wt. 10 oz (284 g)

Carton