21 CFR 876.5021 — Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Gastroenterology, Urology (GU) · Subpart F—Therapeutic Devices · § 876.5021

Identification

A non-medicated topical formulation for treatment of erectile dysfunction. Eroxon is a hydro-alcoholic gel applied to the glans penis that stimulates nerve endings via a rapid cooling effect followed by a warming effect, leading to tumescence and erection. It is intended for the treatment of erectile dysfunction in adult males aged 22 years and over.

Classification Rationale

Class II (special controls). The device is subject to general controls and the identified special controls to mitigate risks such as failure to identify the correct population, deleterious effects on condoms, adverse tissue reactions, and pain or discomfort.

Product Codes