Label: OXYTROL FOR WOMEN- oxybutynin patch

  • NDC Code(s): 11523-4311-1, 11523-4322-2, 11523-4322-4
  • Packager: MSD Consumer Care, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient (in each patch [transdermal system])

    Oxybutynin 3.9 mg/day

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  • Purpose

    Overactive bladder treatment

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  • 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)
      • urinary 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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  • 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, 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
    • if 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.

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  • 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
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  • 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
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  • Inactive ingredients

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

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  • Question or comments?

    Call toll-free 1-888-OXYTROL (1-888-699-8765) between 8:00 AM and 5:00 PM Central Standard Time. Monday through Friday

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  • SPL UNCLASSIFIED SECTION

    Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA,
    a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

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  • PRINCIPAL DISPLAY PANEL - 1 Patch Pouch

    FOLD AT LINE
    TEAR AT ARROW

    NDC 11523-4311-1

    Full Prescription Strength

    OXYBUTYNIN TRANSDERMAL SYSTEM 3.9 mg/day
    Overactive Bladder Treatment

    Oxytrol®
    FOR WOMEN

    RELIEF FROM
    Overactive Bladder

    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.

    1 Patch Treats for
    4 Days/4 Nights

    Contents:
    1
    PATCH
    (Transdermal System)

    PRINCIPAL DISPLAY PANEL - 1 Patch Pouch
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  • PRINCIPAL DISPLAY PANEL - 4 Patch Carton

    New!

    NDC 11523-4322-4

    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 - 4 Patch Carton
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  • INGREDIENTS AND APPEARANCE
    OXYTROL FOR WOMEN 
    oxybutynin patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-4311
    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  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-4311-1 1 in 1 POUCH
    1 4 d in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA202211 08/19/2013
    OXYTROL FOR WOMEN 
    oxybutynin patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11523-4322
    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  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11523-4322-2 8 in 1 CARTON
    1 4 d in 1 PATCH
    2 NDC:11523-4322-4 4 in 1 CARTON
    2 4 d in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA202211 08/19/2013
    Labeler - MSD Consumer Care, Inc. (968091715)
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