tive Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
HYDROXYPROPYL CELLULOSE
SODIUM HYDROXIDE
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52544-084-30 30 PACKET (30 PACKET) in 1 CARTON contains a PACKET
1 1 g in 1 PACKET This package is contained within the CARTON (52544-084-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022204 05/15/2009
GELNIQUE
oxybutynin chloride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52544-078
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN CHLORIDE (OXYBUTYNIN) OXYBUTYNIN CHLORIDE 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
GLYCERIN
HYDROXYPROPYL CELLULOSE
SODIUM HYDROXIDE
WATER
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52544-078-54 1 BOTTLE, PUMP (1 BOTTLE) in 1 CARTON contains a BOTTLE, PUMP
1 30 g in 1 BOTTLE, PUMP This package is contained within the CARTON (52544-078-54)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022204 03/10/2011
Labeler - Watson Pharma, Inc. (966714656)
Revised: 06/2011 Watson Pharma, Inc.
