Itraconazole

INCI: ITRACONAZOLE

CAS Number
84625-61-6
Function
Antifungal agent (pharmaceutical active)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Not permitted for cosmetic use - Itraconazole is an FDA-approved prescription drug (brand name Sporanox); its inclusion in a "cosmetic" product would cause that product to be classified as a drug, requiring NDA/ANDA approval

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Significant - hepatotoxicity (boxed warning), negative inotropic effects (congestive heart failure risk), numerous drug-drug interactions via CYP3A4 inhibition; absolutely not appropriate for cosmetic formulation. Triazole-class antifungal; broad-spectrum activity against dermatophytes, yeasts, and molds; this ingredient appears in CosIng as a reference entry but its pharmaceutical classification precludes cosmetic use

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Concern Level: High

Frequently Asked Questions

Is Itraconazole safe in cosmetics?

Significant - hepatotoxicity (boxed warning), negative inotropic effects (congestive heart failure risk), numerous drug-drug interactions via CYP3A4 inhibition; absolutely not appropriate for cosmetic formulation. Triazole-class antifungal; broad-spectrum activity against dermatophytes, yeasts, and molds; this ingredient appears in CosIng as a reference entry but its pharmaceutical classification precludes cosmetic use The EU classifies Itraconazole as "prohibited". Safety rating: MODERATE.

Is Itraconazole allowed in the EU?

Itraconazole EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Itraconazole do in cosmetics?

Itraconazole functions as: Antifungal agent (pharmaceutical active). It is classified as a cosmetic ingredient in our database. CAS number: 84625-61-6.

What is the Margin of Safety for Itraconazole?

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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