NDC Code(s) : 69451-300-15
Packager : Nuvo Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Pennsaiddiclofenac sodium SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69451-300
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM(UNII: QTG126297Q)
(DICLOFENAC - UNII:144O8QL0L1) 		DICLOFENAC SODIUM15 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHYL SULFOXIDE(UNII: YOW8V9698H)455 mg in 1 g
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)112 mg in 1 g
ALCOHOL(UNII: 3K9958V90M)117.9 mg in 1 g
GLYCERIN(UNII: PDC6A3C0OX)112 mg in 1 g
WATER(UNII: 059QF0KO0R)188.1 mg in 1 g
Product Characteristics
Color PINK (clear, colourless to pink) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69451-300-151 in 1 CARTON 24/04/2010
1160.5 g in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020947 04/24/2010

PRINCIPAL DISPLAY PANEL

Bottle Label



PRINCIPAL DISPLAY PANEL

Carton Label