Synedgen Gets FDA Clearance for Mouth Sore Rinse

June 5, 2020

Synedgen has received FDA 510(k) clearance for its Synvaza over-the-counter mouth sore and wound rinse.

The treatment helps to manage pain and spur healing for mouth sores and ulcers, including traumatic ulcers and surgical injuries.

A clinical trial of the product, which is regulated as a medical device, showed that patients experienced decreased pain from ulcerative oral lesions and decreases in oral soreness when drinking, swallowing, eating, talking and sleeping.

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