DICLOFENAC SODIUM (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label – 150 mL

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Carton Label

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DICLOFENAC SODIUM diclofenac sodium solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-016
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 16.05 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHYL SULFOXIDE
ALCOHOL
PROPYLENE GLYCOL
GLYCERIN
WATER
Product Characteristics
Color PINK, ORANGE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-016-61 1 BOTTLE in 1 CARTON contains a BOTTLE
1 150 mL in 1 BOTTLE This package is contained within the CARTON (40032-016-61)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205878 12/09/2015
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-016), MANUFACTURE (40032-016), PACK (40032-016)

Revised: 06/2016 Novel Laboratories, Inc.

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