The U.S. Food and Drug Administration (FDA) has reviewed the safety of allantoin and permits its use as an active ingredient in Over-The-Counter (OTC) skin protectant drug products at concentrations of 0.5 to 2%.

The safety of allantoin, allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin polygalacturonic acid, allantoin glycyrrhetinic acid and allantoin panthenol has been assessed by the Expert Panel for Cosmetic Ingredient Safety. The Expert Panel evaluated the scientific data and based on the available information concluded that allantoin and the compounds containing allantoin were safe for use as cosmetic ingredients.

Allantoin was not an eye or skin irritant and it was not phototoxic. In genotoxicity tests in bacteria, allantoin was not mutagenic. Allantoin has been shown to reduce the mutagenic activity of hydrogen peroxide. Allantoin was not carcinogenic. The dermal penetration of allantoin in humans was shown to be dependent on the formulation. The greatest penetration observed was from a water/oil ointment. Therapeutic use studies of formulations containing 2-4% allantoin did not report any adverse effects. Although no data were identified on the compounds containing allantoin, the Expert Panel has previously reviewed the safety of ascorbic acid, biotin, glycyrrhetinic acid and panthenol. Galacturonic acid as its polymer, polygalacturonic acid, is a major component of pectin, a polysaccharide found in the cell walls of plants and a common component of food.

Because of its common occurrence in food, the Expert Panel was not concerned with the safety of galacturonic acid or polygalacturonic acid following lower exposure through cosmetics and personal care products. Based on the data on allantoin, and the Expert Panel’s knowledge of the safety of the components in the other compounds included in the report, the Expert Panel concluded that allantoin, allantoin ascorbate, allantoin biotin, allantoin galacturonic acid, allantoin polygalacturonic acid, allantoin glycyrrhetinic acid and allantoin panthenol were safe for use cosmetic ingredients.

Allantoin and the allantoin-containing ingredients may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European Union.