NDC Code(s) : 42192-707-18
Packager : Acella Pharmaceuticals, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

UreaUrea SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42192-707
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA(UNII: 8W8T17847W)
(UREA - UNII:8W8T17847W) 		UREA400 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GLYCERIN(UNII: PDC6A3C0OX)
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) (UNII: 2Q40985DRM)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES(UNII: GO50W2HWO8)
WATER(UNII: 059QF0KO0R)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42192-707-181 in 1 CARTON
118 g in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/22/2009

PRINCIPAL DISPLAY PANEL

NDC 42192-707-18

Urea 40% Nail Film
suspension with appicator

For Topical Use Only
Not for Ophthalmic Use

Rx Only

Net Wt 18 mL

Acella
PHARMACEUTICALS, LLC

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