Allantoin has been classified by the Food and Drug Administration (FDA) Over-The-Counter (OTC) Topical Analgesic Category (safe and effective) active ingredient skin protectant when used between 1.0% to 3.0%. Allantoin has been widely used for decades in cosmetic and OTC topical formulations as anti-inflammatory additive. Allantoin is also present in plants including comfrey, sugar beet, tobacco seed, chamomile, and wheat sprouts. Herbal extract of comfrey is a popular source of allantoin.
