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# OTC Erectile Dysfunction Gel Authorized in U.S.
- URL: https://www.fdaweb.com/otc-erectile-dysfunction-gel-authorized-in-u-s/
- Published: 2023-06-13T12:00:00.000Z
- Updated: 2026-09-14T18:38:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154679

FDA has granted Futura Medical a *de novo* marketing authorization for over-the-counter MED3000, a topical gel formulation for treating erectile dysfunction (ED) . MED3000 works through a “unique evaporative mode of action,” according to the company. The non-medicated hydro-alcoholic gel's authorization is based on data from two Phase 3 studies that demonstrated that the gel “presents an effective clinically proven treatment for ED with a rapid speed of onset and a favorable benefit versus risk profile ideally suited for an ‘over the counter’ classification,” it says.

“Upon application, the volatile components of the formulation (alcohol and water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect,” FDA says. “This stimulates the nerve endings leading to tumescence and erection.”

Futura says about 22 million men in the U.S. suffer from ED. “There has been little innovation in ED treatments for over a decade and many patients continue to suffer dissatisfaction with current therapies and have limited access to safe and effective treatments,” it adds.