Climbazole

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 climbazole. 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. Climbazole 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 within set limits based on SCCS safety opinions. We found no Cosmetic Ingredient Review (CIR) assessment of climbazole.

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 (climbazole not listed).
  • European Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
    • What it shows: EU limits based on SCCS opinions.

2. Composition and Production

Verification: Supported. In the EU, it is permitted up to 2% as an anti-dandruff agent in rinse-off shampoo and, as a preservative, up to 0.5% in shampoo and 0.2% in hair lotions, face creams, and foot care. ORY^® stays within the lower levels.

Citations:

• • European Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
    • What it shows: EU limits.

3. Skin Type Suitability

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

Citations:

• • U.S. Food and Drug Administration. 21 CFR Part 333, Subpart C — Topical antifungal drug products (athlete’s foot and similar claims are drug claims). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-333/subpart-C
    • What it shows: FDA antifungal drug rule.

4. Hair and Scalp Suitability

Verification: Supported, with caveats. In a controlled trial, a shampoo with piroctone olamine and climbazole reduced dandruff more than a zinc pyrithione shampoo. Dandruff is a drug use in the U.S., and this trial tested a combination product.

Citations:

• • 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 of a combination shampoo (a drug use in the U.S.).
  • 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.

5. Benefits

Verification: Supported, with caveats. Reviews describe the role of Malassezia yeast in dandruff. Removing visible flakes by washing is a cosmetic effect; controlling dandruff is a drug claim.

Citations:

• • Ranganathan, S., & Mukhopadhyay, T. (2010). Dandruff: The most commercially exploited skin disease. Indian Journal of Dermatology, 55(2), 130–134. https://pubmed.ncbi.nlm.nih.gov/?term=Dandruff%3A%20the%20most%20commercially%20exploited%20skin%20disease
    • What it shows: Review of dandruff.
  • 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.

6. Use Across ORY^® Product Lines

Verification: Supported. ORY^® keeps levels within EU limits.

Citations:

• • European Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
    • 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 a combination product and EU regulatory review.

Citations:

• • 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.
  • European Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
    • What it shows: EU review.

8. Cons

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

• • Not a U.S. dandruff drug ingredient. Cosmetic claims only.
  • Strict limits. 0.5% shampoo and 0.2% leave-on as a preservative.
  • 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, 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 Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
    • 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: Climbazole is used only in syndet shampoo bars, 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
  • Ranganathan, S., & Mukhopadhyay, T. (2010). Dandruff: The most commercially exploited skin disease. Indian Journal of Dermatology, 55(2), 130–134. https://pubmed.ncbi.nlm.nih.gov/?term=Dandruff%3A%20the%20most%20commercially%20exploited%20skin%20disease
  • 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

• • European Commission. Commission Regulation (EU) 2019/698 amending Annexes III and V to Regulation (EC) No 1223/2009 (climbazole: up to 2% as an anti-dandruff agent in rinse-off shampoo; as a preservative, 0.5% in rinse-off shampoo and 0.2% in hair lotions, face creams, and foot care), based on SCCS opinions SCCS/1506/13, SCCS/1590/17, and SCCS/1600/18. https://eur-lex.europa.eu/eli/reg/2019/698/oj
  • 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
  • U.S. Food and Drug Administration. 21 CFR Part 333, Subpart C — Topical antifungal drug products (athlete’s foot and similar claims are drug claims). https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-333/subpart-C
  • 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