Oxytrol for Women OXYBUTYNIN ALLERGAN, INC. FDA Approved Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)
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Substance Oxybutynin
Route
TRANSDERMAL
Applications
NDA202211

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each patch [transdermal system]) Oxybutynin 3.9 mg/day
Inactive Ingredients
Inactive ingredients acrylic adhesive polyester/ethylene-vinyl acetate film siliconized polyester film and triacetin
Strengths
3.9 mg
Treats Conditions
Use Treats Overactive Bladder In Women You May Be Suffering From Overactive Bladder If You Have Had 2 Or More Of The Following Symptoms For At Least 3 Months Urinary Frequency The Need To Urinate More Often Than Usual Typically More Than 8 Times In 24 Hours Urinary Urgency A Strong Need To Urinate Right Away Urge Incontinence Leaking Or Wetting Yourself If You Cannot Control The Urge To Urinate Non Drug Therapies May Also Help You See The Consumer Information Leaflet Inside The Package

Identifiers & Packaging

Container Type UNKNOWN
UNII
K9P6MC7092
Packaging

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 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

Package Descriptions
  • 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 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

Overview

Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)

Indications & Usage

Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the package)

Dosage & Administration

Directions women 18 years of age and older: How to use the patch: open 1 pouch and apply patch immediately to a clean, dry and smooth area of skin on your abdomen, hips or buttocks. Do not put the patch on oily, damaged (cut or scraped), or irritated (rashes) skin. Do not put the patch on skin with oils, lotions or powders because that could keep the patch from sticking to your skin. wear patch under clothing, do not expose the patch to sunlight do not cut the patch into smaller pieces wear only 1 patch at a time for 4 days in a row after 4 days, remove the used patch and apply a new one change the patch every 4 days for as long as you use this product each time you put on a new patch, change the place where you put it (i.e., abdomen, hips or buttocks) if a patch falls off and you cannot press it back onto your skin, use a new patch How to dispose of a used patch: when you take off a used patch, fold it in half with the sticky sides together throw it away so that it cannot be worn or swallowed by another person, especially a child, or a pet

Warnings & Precautions
Warnings For external use only Frequent urination can also be caused by: urinary tract infections (UTI) diabetes early pregnancy other more serious conditions 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.
Purpose

Purpose Overactive bladder treatment

Do Not Use

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

When Using

When using this product you may have itching, rash or redness where the patch was placed drinking alcohol may increase sleepiness

Stop Use & Ask a Doctor

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

Keep Out of Reach of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions

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 © 2024 AbbVie. All rights reserved. Made in USA Distributed by: AbbVie Inc., North Chicago, IL 60064 OXYTROL and its design are trademarks of Allergan Sales, LLC, an AbbVie company.


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