Allantoin
Allantoin is (2,5-dioxo-4-imidazolidinyl)urea, a nitrogen compound that occurs in some plants such as comfrey but is made commercially by chemical synthesis, usually by condensing urea with glyoxylic acid. It is sold as an odorless white crystalline powder with low solubility in water (well under 1% at room temperature), so formulators dissolve it in the warm water phase or use micronized grades. Complexes with aluminum or other compounds are separate ingredients.
Suppliers sell different products under the same name. Specify the one you need.
White crystalline allantoin, usually 98.5% or higher purity, made to cosmetic or pharmacopeial specifications.
Finely milled allantoin that disperses and dissolves more readily and is less likely to recrystallize as grit.
Compounds such as aluminum chlorohydroxy allantoinate, distinct ingredients with their own names and specs.
Compare each result with your own specification when the lot arrives.
Allantoin is stable; store it in a closed container in a cool, dry place away from strong bases and oxidizers. Reseal micronized grades after use so they do not absorb moisture and cake. Shelf life and retest dates come from the supplier.
Record the assay and, for micronized grades, the particle size of each lot, since coarse lots can recrystallize in finished products. Rotate stock oldest first.
Facts from regulators and standards bodies, each linked to its source.
21 CFR 347.10 lists allantoin, 0.5 to 2 percent, as a skin protectant active ingredient in the OTC skin protectant monograph.
Source: ecfr.gov (opens in a new tab)Health Canada's Natural Health Products Ingredients Database lists allantoin (CAS 97-59-6) as an approved ingredient with the non-medicinal purpose skin-conditioning agent, for topical use.
Source: webprod.hc-sc.gc.ca (opens in a new tab)This is general information, not regulatory advice. Status differs by country and by how the ingredient is used, so check the rules for your product and market.
Manufacturers and distributors whose own websites say they sell it.
Distributor · Eastsound, WA
Washington State seller of cosmetic raw materials in small and bulk sizes, including actives, butters, waxes, emollients, emulsifiers and preservatives, for independent formulators and small brands.
Distributor · Redmond, WA
US supplier of cosmetic ingredients repackaged in retail and bulk sizes, covering actives, butters, oils, waxes and emulsifiers for brands, contract manufacturers and independent formulators.
Suppliers are in alphabetical order and none pays to appear. Each claim is checked against the supplier’s own website on the date shown. Ask for the specification sheet and a recent COA before you order, and confirm details with the supplier.
Common forms include standard crystalline powder, micronized powder and allantoin complexes. Ask each supplier for the specification sheet of the exact grade they quote.
Expect assay, identity, related substances, loss on drying and residue on ignition, particle size and heavy metals, each with its method, specification and result for that lot.
Allantoin is stable; store it in a closed container in a cool, dry place away from strong bases and oxidizers. Reseal micronized grades after use so they do not absorb moisture and cake. Shelf life and retest dates come from the supplier.
21 CFR 347.10 lists allantoin, 0.5 to 2 percent, as a skin protectant active ingredient in the OTC skin protectant monograph. Health Canada's Natural Health Products Ingredients Database lists allantoin (CAS 97-59-6) as an approved ingredient with the non-medicinal purpose skin-conditioning agent, for topical use.
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