The U.S. Food and Drug Administration (FDA) has cleared Sonoma Pharmaceuticals, Inc.’s Microcyn technology based stabilized hypochlorous acid (HOCl) products for the face, eyelid, and eyelashes.
Per this new 510(k) clearance, Sonoma’s Microcyn wound care solution can be used for over-the-counter management of minor skin abrasions, lacerations and irritations, and intact skin on the face, eyelid and eyelashes. The new claim referencing the face will expand how Sonoma can market its OTC dermatology products.
To support this 510(k) clearance, Sonoma was able to demonstrate safety, efficacy and stability for the two-ounce product size.
“These new extended claims exemplify Sonoma’s leadership in developing products based on hypochlorous acid technology under its Microcyn brand. Our new claims around the face, eyelid and eyelash will allow us to further develop industry-leading products to treat common conditions,” says Amy Trombly, CEO of Sonoma, in a news release. “The FDA review process requires increasingly rigorous biocompatibility and performance testing. The expanded indications validate our unparalleled proprietary technology and expertise developed over two decades of working with HOCl as well as our commitment to innovation.”
