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Oxytrol for Women Overactive Bladder Transdermal Patch, 4 Count

Oxytrol for Women Overactive Bladder Transdermal Patch, 4 Count

Oxytrol for Women

OTC drug
  • FDA Approved human OTC drug under New Drug Application (NDA 202211) for treatment of overactive bladder in women.
  • Marketed as an over The Counter oxybutynin transdermal system (3.9 mg/day) with Drug Facts labeling in accordance with U.S. FDA OTC requirements.
  • Packaged and labeled under NDC codes 0023 9637 04 (4 patches) and 0023 9637 08 (32 patches) by Allergan, Inc., an AbbVie company.
Transdermal patch for overactive bladder treatment

Description

Oxytrol for Women is an over-the-counter oxybutynin transdermal patch (3.9 mg/day) indicated for the treatment of overactive bladder in adult women. Each thin, flexible, clear patch is applied to the skin of the abdomen, hip or buttock and delivers a continuous dose of oxybutynin for four days and nights. By relaxing the bladder muscle, it helps reduce urinary frequency, urgency and urge incontinence (accidents). The product is supplied as a carton containing 4 single-use transdermal systems (patches), providing a 16-day supply when used as directed.

Bnefits

  • Provides effective relief of overactive bladder symptoms by relaxing the bladder muscle and reducing frequency, urgency and urge incontinence.
  • First and only FDA-approved over-the-counter transdermal treatment specifically for overactive bladder in women.
  • Each patch delivers 3.9 mg of oxybutynin per day for continuous four-day and four-night symptom control.
  • Convenient dosing: only one patch every four days instead of daily oral tablets.
  • Thin, flexible and clear patch that can be worn discreetly under clothing.
  • Patch can be worn during normal daily activities including showering or exercising when properly applied.
  • Transdermal delivery bypasses initial liver and digestive tract metabolism, helping provide more stable blood levels compared with oral forms.
  • OTC availability allows appropriate adult women with overactive bladder symptoms to access treatment without an initial prescription, following label directions.

Indications

  • Treatment of overactive bladder in women 18 years of age and older.
  • Relief of symptoms associated with overactive bladder such as urinary frequency (typically more than 8 times in 24 hours), urinary urgency and urge urinary incontinence (leaking or wetting if unable to control the urge).

Composition

  • Active ingredient (per transdermal system): Oxybutynin 3.9 mg/day (antimuscarinic/antispasmodic agent).
  • Inactive components of the patch system: acrylic adhesive, polyester/ethylene-vinyl acetate film, siliconized polyester film, triacetin.

Formulation

  • Transdermal patch (transdermal system) designed for twice-weekly use.
  • Delivers oxybutynin 3.9 mg per day continuously over 4 days (up to 96 hours) per patch.
  • Flexible, clear, thin matrix system with adhesive layer containing the active drug.
  • For external use only; applied to intact skin on abdomen, hips or buttocks.
  • Human OTC drug product regulated under an FDA New Drug Application (NDA 202211).

Packaging

  • Carton containing 4 transdermal systems (patches) – 16-day supply when one patch is worn for 4 days.
  • Each patch is individually sealed in a protective pouch to maintain stability and sterility of the system surface prior to use.
  • Additional marketed configuration: carton of 16 or 32 patches (e.g., NDC 0023-9637-08) in some markets, each with individually pouched patches.
  • Typical retail carton dimensions approximately 4.3–4.4 × 4.0–4.2 × 0.9–1.1 inches; net weight about 1–2.1 ounces (varies by listing).

Usage

  • For women 18 years of age and older only; read the full Drug Facts and consumer leaflet before use.
  • Apply to clean, dry, smooth (fold-free) skin on the abdomen, hips or buttocks; avoid oily, cut, scraped, irritated or rash-affected skin.
  • Do not apply to skin that has lotions, oils or powders, as this can interfere with patch adhesion.
  • Open one pouch and apply the patch immediately after removal from the pouch.
  • Remove one part of the protective liner and place the adhesive side of the patch onto the chosen skin site, then peel away the remaining liner and press firmly to ensure full contact.
  • Wear only one patch at a time.
  • Wear the patch continuously for 4 days (up to 96 hours), keeping it under clothing and avoiding direct exposure to sunlight.
  • After 4 days, remove the used patch and immediately apply a new patch to a different area of the abdomen, hips or buttocks to reduce skin irritation.
  • If a patch falls off and cannot be pressed back into place, apply a new patch to a different site and continue the same schedule (do not wear more than one patch at a time).
  • Do not cut the patch into pieces.
  • Wash hands after handling the patch.
  • Follow all additional warnings and directions on the Drug Facts label; consult a doctor if symptoms do not improve after 2 weeks of appropriate use.

Contraindications

  • Hypersensitivity or allergy to oxybutynin or any component of the patch system.
  • Men (product is indicated and labeled only for women; male urinary symptoms may be due to more serious conditions).
  • Children and adolescents under 18 years of age (safety and effectiveness not established).
  • Patients with urinary retention (inability to empty the bladder).
  • Patients with gastric retention or conditions that cause delayed or incomplete stomach emptying.
  • Patients with uncontrolled narrow-angle glaucoma.
  • Do not use if experiencing symptoms suggestive of urinary tract infection or other serious conditions (e.g., burning or pain on urination with fever or chills, blood in urine, unexplained lower back or side pain, foul-smelling or cloudy urine) without first seeing a doctor.
  • Do not use on damaged, broken, or irritated skin at the application site.

Adverse Effects

  • Common anticholinergic-type side effects such as dry mouth, constipation, blurred vision, sleepiness or drowsiness, dizziness and headache.
  • Local skin reactions at the application site including itching, rash, redness or mild irritation.
  • Less commonly, more pronounced application-site reactions such as severe redness, itchiness or blistering at the patch site.
  • Potential urinary retention (difficulty emptying the bladder), particularly in susceptible individuals.
  • Possible confusion or other central nervous system effects, especially in older adults or with concomitant sedating medications.
  • Allergic reactions, including generalized rash or other signs of hypersensitivity; discontinue and seek medical attention if these occur.
  • If any severe or persistent side effects occur, or if new symptoms appear, discontinue use and consult a healthcare professional.

Storage Conditions

  • Store at controlled room temperature, 20° to 25°C (68° to 77°F).
  • Protect from moisture and humidity.
  • Keep patches in their original sealed pouches until immediately before use; do not store the patch outside the pouch.
  • Do not use if the pouch is torn or opened prior to intended use.
  • Keep out of reach of children.
  • Disposal: after removal, fold the used patch in half with the adhesive sides together and discard so it cannot be accidentally worn or ingested by another person, child or pet.

Duration

Each individual patch is worn continuously for 4 days and nights. Treatment for overactive bladder is typically chronic and ongoing; duration of therapy should be determined by the patient and healthcare professional based on symptom control and tolerability.

Onset

The patch begins delivering oxybutynin soon after application; clinical improvement in overactive bladder symptoms is generally observed within the first days to weeks of continued use, though individual response may vary.

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