NDC 0023-9637 Oxytrol For Women

Oxybutynin

NDC Product Code 0023-9637

NDC CODE: 0023-9637

Proprietary Name: Oxytrol For Women What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Oxybutynin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Oxybutynin is used to treat an overactive bladder. By relaxing the muscles in the bladder, oxybutynin improves symptoms such as the inability to control urination (incontinence), feeling that one has to urinate (urgency), and having to go to the bathroom often (frequency). This medication belongs to the class of drugs known as antispasmodics. This medication is not recommended for use in children younger than 5 years of age. Consult your doctor for more information. Unless otherwise directed by your doctor, the over-the-counter product should only be used by adult women who have symptoms of overactive bladder for at least 2 months. For over-the-counter products, carefully read the package instructions to make sure the product is right for you. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

NDC Code Structure

NDC 0023-9637-04

Package Description: 16 PATCH in 1 CARTON > 4 d in 1 PATCH

NDC 0023-9637-08

Package Description: 32 PATCH in 1 CARTON > 4 d in 1 PATCH

NDC Product Information

Oxytrol For Women with NDC 0023-9637 is a a human over the counter drug product labeled by Allergan, Inc.. The generic name of Oxytrol For Women is oxybutynin. The product's dosage form is patch and is administered via transdermal form.

Labeler Name: Allergan, Inc.

Dosage Form: Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Oxytrol For Women Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OXYBUTYNIN 3.9 mg/d

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • TRIACETIN (UNII: XHX3C3X673)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.
  • Transdermal - Administration through the dermal layer of the skin to the systemic circulation by diffusion.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Allergan, Inc.
Labeler Code: 0023
FDA Application Number: NDA202211 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-01-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Information for Patients

Oxybutynin Transdermal Patch

Oxybutynin Transdermal Patch is pronounced as (ox i byoo' ti nin)

Why is oxybutynin transdermal patch medication prescribed?
Oxybutynin transdermal patches are used to treat an overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urg...
[Read More]

* Please review the disclaimer below.

Oxytrol For Women Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient (In Each Patch [Transdermal System])

Oxybutynin 3.9 g/day

Purpose

Overactive bladder treatment

Use

  • Treats overactive bladder in womenyou 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 onlyFrequent urination can also be caused by: urinary tract infections (UTI)  diabetes  early pregnancy  other more serious conditionsIf 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 lossliver 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 applicationIf 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: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 patchHow 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

  • 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

* Please review the disclaimer below.