Oxytrol For Women

Manufacturer
Actavis Pharma, Inc. | Actavis Laboratories UT, Inc.
Effective date
2018-12-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:40:25

Label at a glance#

ProductOxytrol For Women
Active ingredientOXYBUTYNIN
Label structure10 sections

Dosage and administration

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 ...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each patch [transdermal system])

OTC - ACTIVE INGREDIENT SECTION

Oxybutynin 3.9 mg/day

Purpose

OTC - PURPOSE SECTION

Overactive bladder treatment

Use

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

SPL UNCLASSIFIED SECTION

 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 oxybutyni

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • 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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • 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 INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

©Actavis 2015 All rights reserved.
Made in USA
Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA
OXYTROL is a registered trademark of Actavis, Inc.

1660615/Rev. 08/15
229949-00

NDC 52544-166-04
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 1Oxytrol 1Oxytrol 2Oxytrol 2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52544-166-04EA - Each52544-1661d9b0372-7f91-4f16-992f-2a875a427fb012016-09-02
52544-166-08EA - Each52544-166d974b39b-5773-4546-8516-237e6ce398ea12016-09-02
52544-166-54EA - Each52544-166cc41de91-c574-4e85-9cae-a7a541857eef12016-09-02

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52544-16652544-166-08, 52544-166-04, 52544-166-54

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBUTYNINK9P6MC7092ACTIB
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N202211-001OXYTROL FOR WOMENOXYBUTYNIN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25c2088c7a36db…
2026-09-14 22:38:342026-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2584e616aacf4f…
2026-08-18 06:07:402026-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-2587673890dc5c…
2021-03-12 10:30 UTC2021-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253f01610625f2…
2019-09-15 20:21 UTC2019-09N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25b00525d2431f…
2019-07-19 19:46 UTC2019-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253f0d92c62455…
2023-05-13 08:27 UTC2023-05N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-25053a50430f4f…
2023-01-26 05:58 UTC2023-01N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N202211-001OXYTROL FOR WOMEN3.9MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2013-01-253a93d1ddd44b…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N202211-00167434412020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812492020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812502020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812512020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00170812522020-04-26U-1329Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N202211-00171794832020-04-26U-132974a2ff9319b5…
2020-12-22 03:56 UTC2020-12N202211-00167434412020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812492020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812502020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812512020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00170812522020-04-26U-1329Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N202211-00171794832020-04-26U-13298869cabd3fbd…
2020-11-12 02:37 UTC2020-11N202211-00167434412020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812492020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812502020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812512020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00170812522020-04-26U-1329Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N202211-00171794832020-04-26U-1329c0c555d07b60…
2019-12-14 00:12 UTC2019-12N202211-00167434412020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812492020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812502020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812512020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00170812522020-04-26U-1329Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N202211-00171794832020-04-26U-13293f01610625f2…
2019-09-15 20:21 UTC2019-09N202211-00167434412020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812492020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812502020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812512020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00170812522020-04-26U-1329Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N202211-00171794832020-04-26U-1329b00525d2431f…
2019-07-19 19:46 UTC2019-07N202211-00167434412020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812492020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812502020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812512020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00170812522020-04-26U-1329Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N202211-00171794832020-04-26U-1329ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bc5775a5-41f9-4b68-a99a-7c30744d04f35b4b34bb-cba5-409d-beb5-380865f33f632018-12-14WarningsExact identifier
spl id: bc5775a5-41f9-4b68-a99a-7c30744d04f3
spl set id: 5b4b34bb-cba5-409d-beb5-380865f33f63

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.