Piroctone Olamine

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 piroctone olamine. 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.

Please note: Some studies on this page tested this ingredient in people with dandruff or seborrheic dermatitis. In the United States, products that claim to control or treat dandruff are over-the-counter drugs, and this ingredient is not an FDA-approved dandruff drug ingredient. ORY^® products that contain it are cosmetics for scalp and skin cleansing and comfort, not dandruff treatments.

1. General Description and Role

Verification: Supported, with caveats. Piroctone olamine is not an FDA-approved dandruff drug ingredient, so ORY^® does not make dandruff or antifungal claims for it in the United States. The European Union permits it as a preservative at up to 1% in rinse-off products and 0.5% in other products. We found no Cosmetic Ingredient Review (CIR) assessment of piroctone olamine.

Citations:

• • U.S. Food and Drug Administration. 21 CFR 358.710 — Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis (pyrithione zinc 0.3–2% in wash-off products, 0.1–0.25% in leave-on products for dandruff; climbazole and piroctone olamine are not listed). Now OTC Monograph M032. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H/section-358.710
    • What it shows: FDA dandruff drug rule (piroctone olamine not listed).
  • European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
    • What it shows: EU preservative limits.

2. Composition and Production

Verification: Supported. Composition is from supplier data.

Citations:

• • Borda, L. J., & Wikramanayake, T. C. (2015). Seborrheic dermatitis and dandruff: A comprehensive review. Journal of Clinical and Investigative Dermatology, 3(2). https://doi.org/10.13188/2373-1044.1000019
    • What it shows: Describes antifungal ingredients used in dandruff care.

3. Skin Type Suitability

Verification: Limited evidence. We found no cosmetic studies on specific skin types. “Fungal acne” and seborrheic dermatitis claims are drug claims, and ORY^® does not make them.

Citations:

• • U.S. Food and Drug Administration. 21 CFR Part 333, Subpart D — Topical acne drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-333/subpart-D
    • What it shows: FDA acne drug rule.

4. Hair and Scalp Suitability

Verification: Supported, with caveats. In controlled trials, shampoos combining piroctone olamine with salicylic acid or with climbazole reduced dandruff as well as or better than zinc pyrithione shampoos. A small pilot study used an antimicrobial lotion in androgenetic alopecia. These are drug uses in the U.S.; ORY^® does not claim piroctone olamine treats dandruff or hair loss.

Citations:

• • Lodén, M., & Wessman, C. (2000). The antidandruff efficacy of a shampoo containing piroctone olamine and salicylic acid in comparison to that of a zinc pyrithione shampoo. International Journal of Cosmetic Science, 22(4), 285–289. https://doi.org/10.1046/j.1467-2494.2000.00024.x
    • What it shows: Controlled trial (a drug use in the U.S.).
  • Schmidt-Rose, T., Braren, S., Fölster, H., et al. (2011). Efficacy of a piroctone olamine/climbazol shampoo in comparison with a zinc pyrithione shampoo in subjects with moderate to severe dandruff. International Journal of Cosmetic Science, 33(3), 276–282. https://doi.org/10.1111/j.1468-2494.2010.00623.x
    • What it shows: Controlled trial (a drug use in the U.S.).
  • Piérard, G. E., Piérard-Franchimont, C., Nikkels-Tassoudji, N., Nikkels, A. F., & Saint Léger, D. (1996). Improvement in the inflammatory aspect of androgenetic alopecia. A pilot study with an antimicrobial lotion. Journal of Dermatological Treatment, 7(3), 153–157. https://doi.org/10.3109/09546639609086877
    • What it shows: Pilot study in hair loss (a medical use).
  • U.S. Food and Drug Administration. 21 CFR 310.527 — Drug products offered over-the-counter for external use as hair growers or for hair loss prevention. https://www.law.cornell.edu/cfr/text/21/310.527
    • What it shows: FDA hair-growth rule.

5. Benefits

Verification: Supported, with caveats. Removing visible flakes by washing is a cosmetic effect; controlling dandruff is a drug claim.

Citations:

• • Borda, L. J., & Wikramanayake, T. C. (2015). Seborrheic dermatitis and dandruff: A comprehensive review. Journal of Clinical and Investigative Dermatology, 3(2). https://doi.org/10.13188/2373-1044.1000019
    • What it shows: Review of dandruff.
  • European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
    • What it shows: Preservative use.

6. Use Across ORY^® Product Lines

Verification: Supported. It is not used in cold-process soap.

Citations:

• • European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
    • What it shows: EU limits.
  • U.S. Food and Drug Administration. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20
    • What it shows: FDA definition of soap; other bars are cosmetics.

7. Pros

Verification: Supported, with caveats. Evidence is from combination shampoos.

Citations:

• • Lodén, M., & Wessman, C. (2000). The antidandruff efficacy of a shampoo containing piroctone olamine and salicylic acid in comparison to that of a zinc pyrithione shampoo. International Journal of Cosmetic Science, 22(4), 285–289. https://doi.org/10.1046/j.1467-2494.2000.00024.x
    • What it shows: Trial.
  • Schmidt-Rose, T., Braren, S., Fölster, H., et al. (2011). Efficacy of a piroctone olamine/climbazol shampoo in comparison with a zinc pyrithione shampoo in subjects with moderate to severe dandruff. International Journal of Cosmetic Science, 33(3), 276–282. https://doi.org/10.1111/j.1468-2494.2010.00623.x
    • What it shows: Trial.

8. Cons

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

• • Not a U.S. dandruff drug ingredient. Cosmetic claims only.
  • EU limits. 1% rinse-off; 0.5% other products.
  • No CIR review.
  • Rare allergy. Patch test.

Citations:

• • U.S. Food and Drug Administration. 21 CFR 358.710 — Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis (pyrithione zinc 0.3–2% in wash-off products, 0.1–0.25% in leave-on products for dandruff; climbazole and piroctone olamine are not listed). Now OTC Monograph M032. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H/section-358.710
    • What it shows: FDA rule.

9. Safety Notes

Verification: Supported. Follow these precautions:

• • Patch test any new product on a small area for 24–48 hours before full use.
  • If you have a persistent itchy or flaking scalp, or sudden hair shedding, see a dermatologist.
  • Stop use if redness, burning, itching, or rash occurs, and talk to a healthcare provider.
  • For external use only. Avoid the eyes unless the product is made for the eye area.
  • If you are pregnant, nursing, have a medical condition, or are buying for a child, ask a healthcare provider before use.

Citations:

• • European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
    • What it shows: EU limits.

10. Product-line notes

• • ORY^® Skincare: For external use only. Not for deep or puncture wounds, animal bites, or serious burns.
  • ORY^® Haircare: Designed for the look and feel of hair and scalp comfort. Not intended to treat dandruff or scalp conditions, or to promote hair growth or prevent hair loss.
  • ORY^® Handmade Soap line: Piroctone olamine is used only in syndet shampoo bars and liquid cleansers, which are cosmetics under FDA rules, never in cold-process soap.
  • ORY^® Cosmetics: Do not share applicators, and replace any product that changes color, smell, or texture.

11. References

Peer-reviewed research

• • Borda, L. J., & Wikramanayake, T. C. (2015). Seborrheic dermatitis and dandruff: A comprehensive review. Journal of Clinical and Investigative Dermatology, 3(2). https://doi.org/10.13188/2373-1044.1000019
  • Lodén, M., & Wessman, C. (2000). The antidandruff efficacy of a shampoo containing piroctone olamine and salicylic acid in comparison to that of a zinc pyrithione shampoo. International Journal of Cosmetic Science, 22(4), 285–289. https://doi.org/10.1046/j.1467-2494.2000.00024.x
  • Piérard, G. E., Piérard-Franchimont, C., Nikkels-Tassoudji, N., Nikkels, A. F., & Saint Léger, D. (1996). Improvement in the inflammatory aspect of androgenetic alopecia. A pilot study with an antimicrobial lotion. Journal of Dermatological Treatment, 7(3), 153–157. https://doi.org/10.3109/09546639609086877
  • Schmidt-Rose, T., Braren, S., Fölster, H., et al. (2011). Efficacy of a piroctone olamine/climbazol shampoo in comparison with a zinc pyrithione shampoo in subjects with moderate to severe dandruff. International Journal of Cosmetic Science, 33(3), 276–282. https://doi.org/10.1111/j.1468-2494.2010.00623.x

Government and regulatory sources

• • U.S. Food and Drug Administration. 21 CFR 358.710 — Active ingredients for the control of dandruff, seborrheic dermatitis, or psoriasis (pyrithione zinc 0.3–2% in wash-off products, 0.1–0.25% in leave-on products for dandruff; climbazole and piroctone olamine are not listed). Now OTC Monograph M032. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-358/subpart-H/section-358.710
  • European Union. Regulation (EC) No 1223/2009 on cosmetic products, Annex V (allowed preservatives), including entry 56 (iodopropynyl butylcarbamate) and entry 3 (salicylic acid), with use limits and conditions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20240424
  • U.S. Food and Drug Administration. 21 CFR 310.527 — Drug products offered over-the-counter for external use as hair growers or for hair loss prevention. https://www.law.cornell.edu/cfr/text/21/310.527
  • U.S. Food and Drug Administration. 21 CFR Part 333, Subpart D — Topical acne drug products for over-the-counter human use. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-333/subpart-D
  • U.S. Food and Drug Administration. 21 CFR 701.20 — Definition of “soap” (only true soap, made mainly of alkali salts of fatty acids and sold only as soap, is exempt from cosmetic rules). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-G/part-701/subpart-B/section-701.20