Allantoin is a synthetic, free-flowing hygroscopic powder widely used in cosmetic, dermatological and pharmaceutical formulations for its soothing and anti-irritating properties. Allantoin has a moisturizing and keratolytic effect, increasing the water content of the extracellular matrix and enhancing the desquamation of upper layers of dead skin cells, increasing the smoothness of the skin; promoting cell proliferation and wound healing; and a soothing, anti-irritant, and skin protectant effect by forming complexes with irritants and sensitizing agents. Allantoin stimulates healthy, normal tissue formation even at low concentrations. While allantoin is present in botanical extracts of the comfrey plant, it is generally chemically synthesized to meet worldwide demand. Our Allantoin is a nature-identical, synthesized product made to USP specifications. It is non-toxic, non-irritating, and non-allergenic. Allantoin has been classified by the FDA as an Over-The-Counter (OTC) Category I (safe and effective) active ingredient skin protectant. It is FDA approved for this use at 0.5% to 2.0% in formulations. If you include it in your formulations and on your ingredient labels, but make no drug claims for it, it remains a cosmetic ingredient and need not be declared as an “active ingredient.”