3/25/2022: We have switched manufacturers of Allantoin USP. Please review the product specification sheet for more information.
CAS No. 97-59-6
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."
California Prop 65 Statement: The following statement is made in order to comply with the California Safe Drinking Water and Toxic Enforcement Act of 1986. This product may contain trace heavy metals (Pb ≤ 10.0ppm) which are known to the State of California to cause cancer, birth defects or other reproductive harm.
It is an odorless white powder, soluble in water to 0.5%, very slightly soluble in alcohols, insoluble in oils and apolar solvents. Allantoin is stable in the pH range 3-8 and to 80°C prolonged heating.
Allantoin is compatible with most ingredients used in personal care formulations. Water solubility at greater than 0.5% is an issue. Suspending Allantoin in a thick base is the best way to resolve this issue. When formulating, care should be taken to look for Allantoin recrystallization.
To incorporate 0.5% Allantoin, or more, into an emulsion product, the emulsion is made and Allantoin is added during the cooling process below 50°C (122°F). Good agitation is required to thoroughly disperse the Allantoin to achieve a suitable suspension. Addition of Allantoin at 0.5% or more or at temperatures above 50°C (122°F) in aqueous systems can cause solubilization and recrystallization upon cooling into larger particles which are perceptible during product use.
Recommended Use Rate: 0.1 - 2.0%
Country of Origin: Italy
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