Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 8cdc5b4d-ff8d-4010-97d7-313422a0b868
Route
TRANSDERMAL
Published
Effective Date 2024-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Oxybutynin (3.9 mg)
Inactive Ingredients
Triacetin

Identifiers & Packaging

Marketing Status
NDA Active Since 2016-01-01

Description

Oxybutynin 3.9 mg/day

Purpose

Overactive bladder treatment


Medication Information

Purpose

Overactive bladder treatment

Description

Oxybutynin 3.9 mg/day

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)
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.

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
Do Not Use
  • 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
Other Information
  • product comes in individual sealed pouches, do not use if pouch is torn or opened

  • store between 20° to 25°C (68° to 77°F)

  • protect from moisture and humidity

  • do not store outside the sealed pouch
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

© 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.

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

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
Keep Out of Reach of Children.

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

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)
Active Ingredient (in Each Patch [transdermal System])

Oxybutynin 3.9 mg/day


Structured Label Content

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)
Purpose

Overactive bladder treatment

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.

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
Do Not Use (Do not use)
  • 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
Other Information (Other information)
  • product comes in individual sealed pouches, do not use if pouch is torn or opened

  • store between 20° to 25°C (68° to 77°F)

  • protect from moisture and humidity

  • do not store outside the sealed pouch
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (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.

Principal Display Panel (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

When Using This Product (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 (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.

Ask A Doctor Before Use If You Have (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 (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)
Active Ingredient (in Each Patch [transdermal System]) (Active ingredient (in each patch [transdermal system]))

Oxybutynin 3.9 mg/day


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)