Allantoin has been classified by the Food and Drug Administration (FDA) Over-the-Counter (OTC) Topical Analgesic Review Panel as a Category I (safe and effective) active ingredient skin protectant when used at 2.0%. Allantoin has been widely used for decades in cosmetic and OTC topical formulations because it is so effective at only 0.5% making it an economical anti-inflammatory additive. The most popular applications are in the prevention and treatment of dry and chapped skin and lips.