OXYTROL FOR WOMEN- oxybutynin patch 
Allergan, Inc.

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Drug Facts

Active ingredient (in each patch [transdermal system])

Oxybutynin 3.9 mg/day

Purpose

Overactive bladder treatment

Use

Warnings

For external use only

Frequent urination can also be caused by:

If you think you might have one of these conditions, it is important to see your doctor before use.

Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you.

Do not use if you

  • have any of these symptoms, which could be the sign of a UTI or other serious condition.
    See your doctor as soon as possible if you have:
    pain or burning when urinating. These symptoms may also be accompanied by a fever or chills.
    blood in your urine
    unexplained lower back or side pain
    urine that is cloudy, or foul-smelling
    are male. Your symptoms may be due to a more serious condition.
    are under the age of 18. It is not known if it works or is safe in children.
    only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition.
    have been told by a doctor you have urinary retention (are not able to empty your bladder)
    have been told by a doctor you have gastric retention (your stomach empties slowly after a meal)
    have glaucoma
    are allergic to oxybutynin

Ask a doctor before use if you have

  • symptoms of diabetes, such as:
    excessive thirst
    extreme hunger
  • unexplained weight loss
  • liver or kidney disease

Ask a doctor or pharmacist before use if you are

  • taking a prescription medication for overactive bladder
  • taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision
  • taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example, ketoconazole, itraconazole)

When using this product

  • you may have itching, rash or redness where the patch was placed
  • drinking alcohol may increase sleepiness

Stop use and ask a doctor if

  • you are not able to empty your bladder (urinary retention)
  • condition worsens, or if new symptoms appear
  • condition does not improve after 2 weeks of use
  • you have an allergic reaction to this product
  • you have severe redness, itchiness or blistering at the site of application

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

women 18 years of age and older:

How to use the patch:

How to dispose of a used patch:

Other information

Inactive ingredients

acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, and triacetin

Questions or comments?

Call toll-free: 1-888-OXYTROL (1-888-699-8765) between 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

© 2018 Allergan. All rights reserved.

Made in USA

Distributed by: Allergan USA, Inc., Madison, NJ 07940

OXYTROL® and its design are registered trademarks of Allergan Sales, LLC.

PRINCIPAL DISPLAY PANEL

NDC 0023-9637-04
Full Prescription Strength
OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day
Overactive Bladder Treatment
Oxytrol®
FOR WOMEN
RELIEF FROM
Overactive Bladder
1 Patch Treats for
4 Days/4 Nights

4 PATCHES
(Transdermal Systems)
16-Day Supply

NDC 0023-9637-04
Full Prescription Strength
OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day
Overactive Bladder Treatment
Oxytrol®
FOR WOMEN
RELIEF FROM
Overactive Bladder
1 Patch Treats for
4 Days/4 Nights

4 PATCHES
(Transdermal Systems)
16-Day Supply

OXYTROL FOR WOMEN 
oxybutynin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-9637
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBUTYNIN (UNII: K9P6MC7092) (OXYBUTYNIN - UNII:K9P6MC7092) OXYBUTYNIN3.9 mg  in 1 d
Inactive Ingredients
Ingredient NameStrength
TRIACETIN (UNII: XHX3C3X673)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0023-9637-0416 in 1 CARTON01/01/2016
14 d in 1 PATCH; Type 0: Not a Combination Product
2NDC:0023-9637-0832 in 1 CARTON10/01/2019
24 d in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20221101/01/2016
Labeler - Allergan, Inc. (144796497)

Revised: 8/2016
Document Id: bfd95021-d60e-4842-be48-20cfab631ccd
Set id: 8cdc5b4d-ff8d-4010-97d7-313422a0b868
Version: 5
Effective Time: 20160813
 
Allergan, Inc.