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Frequently Asked Questions

What is the indication for Oxytrol® For Women?

Oxytrol® For Women is indicated for women ≥18 years of age with 2 or more of the following symptoms for at least 3 months: urinary frequency, urinary urgency and urge incontinence.

On what basis did the FDA approve Oxytrol® For Women for OTC use?

Oxytrol® For Women safety and effectiveness for OTC use were established in more than 5,000 subjects participating in 9 studies. [8] Overall, results from these studies showed that consumers can understand the information on the label, properly select whether the product is right for them, and use the drug appropriately. [8]

Is OTC Oxytrol® For Women different from prescription Oxytrol®?

Both versions have the same formulation and same dosage strength.
It is important to note that Oxytrol® For Women is only indicated for women ≥18 years of age or older. All other indications remain prescription only.

How does delivery of oxybutynin differ between the patch and oral formulations?

Oxybutynin delivered via the patch avoids presystemic gastrointestinal and hepatic first-pass metabolism vs the oral formulation. [9]

Where will women find Oxytrol® For Women in stores?

Oxytrol® For Women will be found in the Feminine Care Aisle.

What are the most common side effects of Oxytrol® For Women?

Consumers may have itching, rash, or redness where patch applied [10,11]

  • In pivotal clinical trials more than 70% of patients in 1 clinical trial reported no application site reactions with transdermal oxybutynin 3.9 mg/day, and the reported site reactions in both pivotal trials were mostly mild or moderate [11]

Oxytrol® For Women Drug Facts label states that sleepiness, dizziness, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you. Drinking alcohol may increase sleepiness.

In a 12-week, double-blind, randomized, placebo-controlled study

  • Incidence of dry mouth with transdermal oxybutynin 3.9 mg/day was comparable with placebo group (9.6% vs 8.3%, respectively) [10]

Is it okay for the Oxytrol® For Women patch to get wet?

Yes. Adhesion of the patch and delivery of oxybutynin are not affected by bathing, swimming, or exercise.

Is it okay for Oxytrol® For Women to be exposed to sunlight?

Wear the patch under clothing, do not expose the patch to sunlight.