Allantoin

At ORY^®, we believe you should know what’s in your products and why. This page lists the published research behind what we say about allantoin. Each section starts with our claim, then tells you how well the research supports it, then lists the sources so you can read them yourself.

1. General Description and Role

Verification: Supported. Allantoin has a long record of cosmetic use. The CIR Expert Panel, an independent scientific panel, reviewed the safety data and found it safe at the concentrations used in cosmetics (up to 2%). The FDA also permits allantoin at 0.5–2% as the active ingredient in some over-the-counter skin protectant products. That status belongs to the ingredient in drug products; ORY^®; products are cosmetics.

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: The CIR safety review: allantoin was found safe as used in cosmetics, at concentrations up to 2%, in more than 1,300 products.
  • S. Food and Drug Administration. 21 CFR Part 347 — Skin Protectant Drug Products for Over-the-Counter Human Use (see also OTC Monograph M016). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
    • What it shows: FDA rule listing allantoin (0.5–2%) as a permitted active ingredient in over-the-counter skin protectant drug products.

2. Composition and Production

Verification: Supported. The chemistry, natural sources, and production method are well documented. Purified allantoin is a single, defined compound, which is different from raw comfrey extract.

Citations:

• • Bakibaev, A. A., Il’yasov, S. G., Tatarenko, O. V., et al. (2020). Allantoin: Synthesis and chemical properties. Bulletin of the University of Karaganda – Chemistry, 97(1), 7–21. https://doi.org/10.31489/2020CH1/7-21
    • What it shows: Reviews how allantoin is made (including from urea and glyoxylic acid) and lists its properties, including water solubility of about 5.7 g per liter at 25 °C.
  • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Describes allantoin’s chemical identity and natural sources.
  • National Institute of Diabetes and Digestive and Kidney Diseases. (2022). Comfrey. In LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. https://www.ncbi.nlm.nih.gov/books/NBK548370/
    • What it shows: S. government reference explaining that comfrey’s pyrrolizidine alkaloids can harm the liver when taken internally, which is why ORY^® uses purified allantoin, not comfrey extract.

3. Skin Type Suitability

Verification: Supported, with caveats. Human patch testing found allantoin does not cause allergic sensitization, which supports its use on all skin types. Its soothing effects come mainly from laboratory and animal studies; large human trials of allantoin on its own are limited.

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Repeated patch testing in people showed allantoin did not cause sensitization.
  • Zhang, P., Wang, Y., Zhang, J., & Hong, T. (2022). Allantoin inhibits compound 48/80-induced pseudoallergic reactions in vitro and in vivo. Molecules, 27(11), 3473. https://doi.org/10.3390/molecules27113473
    • What it shows: Lab and mouse study: allantoin reduced the release of histamine and other irritation signals from mast cells.
  • Araújo, L. U., Grabe-Guimarães, A., Mosqueira, V. C. F., Carneiro, C. M., & Silva-Barcellos, N. M. (2010). Profile of wound healing process induced by allantoin. Acta Cirúrgica Brasileira, 25(5), 460–466. https://doi.org/10.1590/S0102-86502010000500014
    • What it shows: Animal study: skin treated with allantoin showed fewer inflammatory cells and more organized tissue.

4. Hair and Scalp Suitability

Verification: Limited evidence. We found no published clinical study of allantoin on its own on the scalp. Our scalp claims are based on how allantoin behaves on skin, since the scalp is skin. We keep these claims modest for that reason. ORY^® haircare products are not intended to treat dandruff or scalp conditions, or to grow hair or prevent hair loss.

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Confirms allantoin is used safely in hair products as well as skin products.
  • Zhang, P., Wang, Y., Zhang, J., & Hong, T. (2022). Allantoin inhibits compound 48/80-induced pseudoallergic reactions in vitro and in vivo. Molecules, 27(11), 3473. https://doi.org/10.3390/molecules27113473
    • What it shows: Shows soothing activity in lab models, which is the basis for expecting similar comfort on the scalp.

5. Benefits

Verification: Supported, with caveats. The gentle smoothing (mild keratolytic) effect is well described. Soothing effects are supported mainly by lab and animal research. Animal studies also suggest allantoin plays a role in skin repair, but a large human trial of 6% allantoin cream did not find a benefit over the plain cream base. That is why ORY^®does not make wound-healing claims.

Citations:

• • Thornfeldt, C. (2005). Cosmeceuticals containing herbs: Fact, fiction, and future. Dermatologic Surgery, 31(7 Pt 2), 873–880. https://doi.org/10.1111/j.1524-4725.2005.31734
    • What it shows: Review of plant-derived cosmetic ingredients describing allantoin’s soothing and gentle smoothing (keratolytic) actions.
  • Araújo, L. U., Grabe-Guimarães, A., Mosqueira, V. C. F., Carneiro, C. M., & Silva-Barcellos, N. M. (2010). Profile of wound healing process induced by allantoin. Acta Cirúrgica Brasileira, 25(5), 460–466. https://doi.org/10.1590/S0102-86502010000500014
    • What it shows: Rat study using 5% allantoin: faster return to normal skin structure.
  • Savić, V. Lj., Nikolić, V. D., Arsić, I. A., et al. (2015). Comparative study of the biological activity of allantoin and aqueous extract of the comfrey root. Phytotherapy Research, 29(8), 1117–1122. https://doi.org/10.1002/ptr.5356
    • What it shows: Lab and animal comparison of pure allantoin and comfrey root extract.
  • Paller, A. S., Browning, J., Nikolic, M., et al. (2020). Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: A phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study). Orphanet Journal of Rare Diseases, 15, 158. https://doi.org/10.1186/s13023-020-01419-3
    • What it shows: Large human trial (Phase 3): 6% allantoin cream was well tolerated, but wound closure was not significantly different from the plain cream (49.4% vs. 53.6%).

6. Use Across ORY^® Product Lines

Verification: Supported. The levels ORY^® uses are within the range the CIR Expert Panel reviewed as safe (up to 2%).

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Safety conclusion covering use levels up to 2%.
  • Vogels, G. D., et al. (1969). Hydrolysis and racemization of allantoin. Recueil des Travaux Chimiques des Pays-Bas, 88(8). https://doi.org/10.1002/recl.19690880807
    • What it shows: Chemistry study showing allantoin breaks down (hydrolyzes) in alkaline conditions, which is why ORY^® adds it after the lye stage in soap.
  • S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
    • What it shows: FDA explains when soap is regulated as soap, a cosmetic, or a drug.

7. Pros

Verification: Supported. Allantoin’s safety record and low use levels are well documented. It is stable in the mildly acidic to near-neutral range typical of skin care; it breaks down under strongly alkaline conditions.

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Safety and sensitization data.
  • Vogels, G. D., et al. (1969). Hydrolysis and racemization of allantoin. Recueil des Travaux Chimiques des Pays-Bas, 88(8). https://doi.org/10.1002/recl.19690880807
    • What it shows: Shows the alkaline conditions under which allantoin breaks down.

8. Cons

Verification: Supported. We list these limits so you have the full picture:

• • Supportive, not transformative. On its own, allantoin gives modest results for wrinkles, dark spots, or breakouts. It works best alongside targeted ingredients.
  • Mixed human evidence. Most repair research is in animals. A large human trial of 6% allantoin cream did not beat the plain cream base.
  • Limited solubility. Higher amounts need warming and may re-crystallize in clear products.
  • Comfrey confusion. Allantoin is not the same as comfrey extract. ORY^® uses purified allantoin only.

Citations:

• • Paller, A. S., Browning, J., Nikolic, M., et al. (2020). Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: A phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study). Orphanet Journal of Rare Diseases, 15, 158. https://doi.org/10.1186/s13023-020-01419-3
    • What it shows: Human trial showing no significant wound-closure benefit over the plain cream.
  • Bakibaev, A. A., Il’yasov, S. G., Tatarenko, O. V., et al. (2020). Allantoin: Synthesis and chemical properties. Bulletin of the University of Karaganda – Chemistry, 97(1), 7–21. https://doi.org/10.31489/2020CH1/7-21
    • What it shows: Water solubility data.
  • National Institute of Diabetes and Digestive and Kidney Diseases. (2022). Comfrey. In LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. https://www.ncbi.nlm.nih.gov/books/NBK548370/
    • What it shows: Background on comfrey’s liver-toxicity concerns when taken internally.

9. Safety Notes

• • Allergic reactions to allantoin are rare. Patch test any new product on a small area for 24–48 hours before full use.
  • Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
  • For external use only. Avoid the eyes. Do not use on broken, infected, or seriously damaged skin.
  • If you are pregnant, nursing, have a medical condition, or are buying for a young child, ask a healthcare provider before use.

Citations:

• • Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
    • What it shows: Human patch-test data showing allantoin is non-sensitizing.

10. Product-line notes

• • ORY^® Haircare: Designed for scalp comfort and the look and feel of hair. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss. If you notice sudden shedding or a persistent itchy, flaking scalp, see a dermatologist.
  • ORY^® Handmade Soap: Handmade soap is naturally alkaline, and each bar may vary slightly in color, scent, and texture. Not intended to treat eczema or any skin condition.
  • ORY^® Cosmetics: Lip products are not intended to treat or protect chapped or cracked lips. Do not share applicators, and replace any product that changes color, smell, or texture.
  • ORY^® Skincare: Not for deep or puncture wounds, animal bites, or serious burns.

11. References

Peer-reviewed research

1. 1. Araújo, L. U., Grabe-Guimarães, A., Mosqueira, V. C. F., Carneiro, C. M., & Silva-Barcellos, N. M. (2010). Profile of wound healing process induced by allantoin. Acta Cirúrgica Brasileira, 25(5), 460–466. https://doi.org/10.1590/S0102-86502010000500014
   2. Bakibaev, A. A., Il’yasov, S. G., Tatarenko, O. V., et al. (2020). Allantoin: Synthesis and chemical properties. Bulletin of the University of Karaganda – Chemistry, 97(1), 7–21. https://doi.org/10.31489/2020CH1/7-21
   3. Becker, L. C., Bergfeld, W. F., Belsito, D. V., et al. (2010). Final report of the safety assessment of allantoin and its related complexes. International Journal of Toxicology, 29(3 Suppl), 84S–97S. https://doi.org/10.1177/1091581810362805
   4. Paller, A. S., Browning, J., Nikolic, M., et al. (2020). Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: A phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study). Orphanet Journal of Rare Diseases, 15, 158. https://doi.org/10.1186/s13023-020-01419-3
   5. Savić, V. Lj., Nikolić, V. D., Arsić, I. A., et al. (2015). Comparative study of the biological activity of allantoin and aqueous extract of the comfrey root. Phytotherapy Research, 29(8), 1117–1122. https://doi.org/10.1002/ptr.5356
   6. Thornfeldt, C. (2005). Cosmeceuticals containing herbs: Fact, fiction, and future. Dermatologic Surgery, 31(7 Pt 2), 873–880. https://doi.org/10.1111/j.1524-4725.2005.31734
   7. Vogels, G. D., et al. (1969). Hydrolysis and racemization of allantoin. Recueil des Travaux Chimiques des Pays-Bas, 88(8). https://doi.org/10.1002/recl.19690880807
   8. Zhang, P., Wang, Y., Zhang, J., & Hong, T. (2022). Allantoin inhibits compound 48/80-induced pseudoallergic reactions in vitro and in vivo. Molecules, 27(11), 3473. https://doi.org/10.3390/molecules27113473

Government and regulatory sources

• • U.S. Food and Drug Administration. 21 CFR Part 347 — Skin Protectant Drug Products for Over-the-Counter Human Use (see also OTC Monograph M016). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-347
  • U.S. Food and Drug Administration. Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
  • National Institute of Diabetes and Digestive and Kidney Diseases. (2022). Comfrey. In LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. https://www.ncbi.nlm.nih.gov/books/NBK548370/