November 26, 2015
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"The U.S. Food and Drug Administration today allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired d"...


How Supplied


ANTUROL (oxybutynin) gel 3% is a muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies].


The recommended dosage is three pumps of ANTUROL (84 mg/day) applied once daily to clean, dry, intact skin on the abdomen, or upper arms/shoulders, or thighs. Apply immediately after actuating the dose. Application sites may be rotated to reduce the potential for local site reactions [see ADVERSE REACTIONS]. ANTUROL is for topical application only and should not be ingested. Wash hands immediately after product application. Patients should cover the application site with clothing after the gel has dried if direct skin-to-skin contact at the application site is anticipated [see WARNINGS AND PRECAUTIONS].


Dosage Forms and Strengths

ANTUROL is a homogeneous, colorless to slightly colored gel 3%.

ANTUROL (oxybutynin) gel 3% is supplied in a metered-dose pump dispenser composed of an inner aluminum laminated foil liner encased in a rigid plastic bottle with a plastic cap. The nozzle of the pump dispenser is sealed by a removable cap attached to the actuator by a plastic string.

How Supplied

55948-301-01 2 x 45 mL (2 x 42g) metered pump dispensers each containing 30 metered 0.92 g (1.0 mL) pumps delivering 28 mg oxybutynin per pump actuation.

55948-301-02 100 mL (92g) metered pump dispenser containing 90 metered 0.92 g (1 mL) pumps delivering 28 mg oxybutynin per pump actuation.


Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). See USP controlled room temperature. Protect from moisture and humidity.

Antares Pharma, Inc. Ewing, NJ 08618 USA. Issued: December 2011

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/3/2012

How Supplied

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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