OXYTROL (Page 5 of 5)

Instructions for Use

OXYTROL (OKSEE TROLE)

(oxybutynin transdermal system)

Read this Instructions for Use that comes with your OXYTROL before you start using it and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

Where to apply OXYTROL:

  • Put the patch on a clean, dry, and smooth (fold-free) area of skin on your abdomen (stomach area), hips or buttocks. See Figure A.
  • Avoid your waistline area, since tight clothing may rub against the patch.
  • The areas you choose should not be oily, damaged (cut or scraped), irritated (rashes) or have any other skin problems.
  • Do not put OXYTROL on areas that have been treated with oils, lotions, or powders that could keep the patch from sticking well to your skin.
  • When you put on a new patch, use a different area of skin from the most recent patch site. You may find it useful to change the site from one side of your body to the other.
  • Do not use the same area for the patch for at least 7 days. You may choose to try different sites when using OXYTROL to find the sites that are most comfortable for you and where clothing will not rub against it.

·	Do not use the same area for the patch for at least 1 week. You may choose to try different sites when using OXYTROL to find the sites that are most comfortable for you and where clothing will not rub against it.
(click image for full-size original)

How to apply OXYTROL:

Step 1.

  • Each patch is sealed in its own protective pouch. See Figure B.
  • When you are ready to put on your OXYTROL patch, tear open the pouch and remove the patch. See Figure C.
·	Each patch is sealed in its own protective pouch. See Figure B.
·	When you are ready to put on your OXYTROL patch, tear open the pouch and remove the patch. See Figure C.
(click image for full-size original)

Step 2.

  • The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner. See Figure D.
  • Remove the first piece of the protective liner and place the patch, adhesive face down, firmly onto the skin. See Figure E.
·	The sticky adhesive side of the patch is covered by 2 strips of overlapping protective liner. See Figure D.
·	Remove the first piece of the protective liner and place the patch, adhesive face down, firmly onto the skin. See Figure E.
(click image for full-size original)

Step 3.

  • Bend the patch in half and gently roll the remaining part onto your skin using the tips of your fingers. As you roll the patch in place, the second piece of the protective liner should come off the patch. See Figure F.
  • Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. See Figure G.
  • When putting on the patch, avoid touching the sticky adhesive side.
  • Touching the adhesive may cause the patch to fall off early.
  • Throw away the protective liners.
  • If the patch partly or completely falls off, press it back in place and continue to follow your application schedule.
  • If the patch does not stay on, throw it away. Put on a new patch on a different area of skin, and continue to follow your original application schedule.
  • If you forget to change your patch after 3 or 4 days, remove the old patch, put on a new patch in a different area of skin and continue to follow your original application schedule.

·	Bend the patch in half and gently roll the remaining part onto your skin using the tips of your fingers. As you roll the patch in place, the second piece of the protective liner should come off the patch. See Figure F.
·	Apply firm pressure over the surface of the patch with your fingers to make sure the patch stays on. See Figure G.
(click image for full-size original)

How to remove OXYTROL:

  • When changing your OXYTROL patch, remove the old patch slowly and carefully to avoid damaging your skin.
  • After the old patch is removed, fold it in half with the sticky sides together.
  • The patch will still contain some oxybutynin . T hrow the patch away so that it cannot be worn or swallowed by another person, child, or pet.
  • Gently wash the application site with warm water and a mild soap to remove any adhesive that stays on your skin after removing the patch.
  • A small amount of baby oil may also be used to remove any adhesive remaining on your skin. Rings of adhesive that become dirty may need a medical adhesive removal pad that you can get from your pharmacist.
  • Alcohol or other dissolving liquids (nail polish remover or other solvents) may cause skin irritation and should not be used.

This Patient In formation and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Distributed By:
AbbVie, Inc.
North Chicago, IL 60064

© 2023 AbbVie. All rights reserved.

OXYTROL and its design are trademarks of Allergan Sales, LLC, an AbbVie company.

Revised: 11/2023

PRINCIPA L DISPLAY PANEL

NDC 0023-6153-08
OXYTROL®
Oxybutynin Transdermal System
3.9 mg/day
Nominal delivery of 3.9 mg/day.
Continuous delivery for twice weekly dosing.
Each 39 cm2 system contains 36 mg oxybutynin.
Inactive Components: triacetin, USP; acrylic adhesive;
polyester/ethylene-vinyl acetate film, and siliconized polyester film.
Contains 8 transdermal systems
Keep out of reach of children.Rx only

PRINCIPAL DISPLAY PANEL
NDC 0023-6153-08
OXYTROL® 
Oxybutynin Transdermal System
3.9 mg/day
Nominal delivery of 3.9 mg/day.
Continuous delivery for twice weekly dosing.
Each 39 cm2 system contains 36 mg oxybutynin.
Inactive Components: triacetin, USP; acrylic adhesive;
polyester/ethylene-vinyl acetate film, and siliconized polyester film.
Contains 8 transdermal systems
Keep out of reach of children.
Rx only
(click image for full-size original)

OXYTROL oxybutynin patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-6153
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYBUTYNIN (OXYBUTYNIN) OXYBUTYNIN 3.9 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
TRIACETIN
Product Characteristics
Color Score
Shape Size
Flavor Imprint Code OXYTROL3;9mg;day
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-6153-08 8 POUCH in 1 BOX contains a POUCH
1 1 PATCH in 1 POUCH This package is contained within the BOX (0023-6153-08) and contains a PATCH
1 4 d in 1 PATCH This package is contained within a POUCH and a BOX (0023-6153-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021351 02/26/2003
Labeler — Allergan, Inc. (144796497)

Revised: 11/2023 Allergan, Inc.

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