Description
A natural diureide of glyoxylic acid first identified in comfrey root and now produced synthetically. The most widely used skin-soothing and mild keratolytic active in mass-market cosmetic formulation, recognized as a Category I skin protectant in the U.S. FDA OTC monograph.
White, odorless, crystalline powder. Limited water solubility (about 0.5 percent at 25 °C), increasing with temperature. Stable across the cosmetic pH range and compatible with virtually all cosmetic actives.
We supply cosmetic-grade Allantoin from manufacturers in China holding ISO 22716, ISO 9001, Halal, Kosher and pharmaceutical-GMP certifications relevant to the product and production.
Common market grades include Cosmetic Grade 98.5% min and Pharmacopoeial Grade USP/EP for crossover use. Both forms are commercial; the price differential is minimal. Micronized grades for clear-gel formulations are also available.
Bulk and reduced-MOQ shipments. Batch-level COA covering HPLC purity, melting point, related substances, heavy metals, and microbiology.
Introduction
Allantoin was first isolated from amniotic fluid in 1799 (the name derives from allantois) and later identified as the principal active in comfrey root extracts that had been used for wound healing since antiquity. Cosmetic and pharmaceutical use began in the 1930s, and allantoin is now ubiquitous in mass-market skincare globally.
Industrial production is by synthetic condensation of glyoxylic acid with urea, followed by crystallization. The process produces high-purity material at low cost, displacing comfrey-derived extracts in commercial cosmetic supply.
Regulatory status is exceptionally permissive. U.S. FDA OTC monograph recognizes allantoin as a Category I skin protectant at 0.5 to 2 percent. EU CosIng lists it as a permitted cosmetic ingredient with no concentration limit. China IECIC lists allantoin with no restriction. Japan PMDA permits use in quasi-drug formulations.
Clinical evidence supports allantoin for wound healing, skin protection, and gentle keratolytic activity. Peer-reviewed studies demonstrate reduction in skin dryness, irritation scores, and stratum corneum desquamation at 0.5 to 2 percent over 4 to 8 weeks. The molecule is essentially non-irritating and non-sensitizing.
Strategically, allantoin is one of the most-used soothing actives in the global cosmetic industry, present in tens of thousands of finished products. Demand is steady and price is set by commodity-style competition among Chinese, Indian, and European synthetic producers.
Where it is used
- Soothing creams and lotions for sensitive skin (typical use 0.2 to 2 percent)
- Baby creams, balms, and diaper-rash products
- Sun care, after-sun lotions, and post-procedure recovery products
- Anti-acne and post-shave products
- Hand creams, foot creams, and elbow-knee softeners
- Lip balms and chapping treatments
- Hair masks and scalp soothers
- Combination formulations with panthenol, niacinamide, and Centella
- Skin protectant OTC drug products under the U.S. monograph
Technical data
| Item | Specification |
|---|---|
| Appearance | White odorless crystalline powder |
| INCI Name | Allantoin |
| Assay (HPLC, dry basis) | ≥ 98.5% |
| Melting point (decomposition) | 230 °C to 236 °C |
| Loss on drying | ≤ 0.5% |
| pH (0.5% solution) | 5.0 to 6.0 |
| Related substances (each) | ≤ 0.1% |
| Heavy metals (as Pb) | ≤ 10 mg/kg |
| Arsenic | ≤ 2 mg/kg |
| Residue on ignition | ≤ 0.1% |
| Total plate count | ≤ 100 CFU/g |
| E. coli, Salmonella, S. aureus, P. aeruginosa | Negative |
| Source | Synthetic, glyoxylic acid plus urea condensation |
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