Regulatory Status
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Safety Data
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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.
Regulatory Flags
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.
Compliance Tools
Check Clotrimazole compliance across multiple jurisdictions:
Related Ingredients
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