Clotrimazole

INCI: CLOTRIMAZOLE

CAS Number
23593-75-1
Function
Antifungal agent (pharmaceutical active ingredient — azole class)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.5%
🇺🇸 US Status permitted
US Notes OTC/Rx Antifungal Drug — Regulated as an active pharmaceutical ingredient. FDA-approved for topical antifungal treatment. Use in cosmetics would classify the product as a drug requiring NDA/ANDA

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
low

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Drug substance — inclusion in a cosmetic product would reclassify the product as a drug in both EU and US jurisdictions. Antimicrobial resistance concerns raised by SCCS/SCCNFP and EMA CHMP. Do not formulate in cosmetics.

⚠️
Concern Level: High

Regulatory Flags

endocrine_disruptor

Frequently Asked Questions

Is Clotrimazole safe in cosmetics?

Drug substance — inclusion in a cosmetic product would reclassify the product as a drug in both EU and US jurisdictions. Antimicrobial resistance concerns raised by SCCS/SCCNFP and EMA CHMP. Do not formulate in cosmetics. The EU classifies Clotrimazole as "restricted". Safety rating: POOR.

Is Clotrimazole allowed in the EU?

Clotrimazole EU regulatory status: restricted. Maximum allowed concentration: 0.5%. This is based on EU Regulation 1223/2009 and its amendments.

What does Clotrimazole do in cosmetics?

Clotrimazole functions as: Antifungal agent (pharmaceutical active ingredient — azole class). It is classified as a cosmetic ingredient in our database. CAS number: 23593-75-1.

What is the Margin of Safety for Clotrimazole?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

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