Bifonazole

INCI: BIFONAZOLE

CAS Number
60628-96-8
Function
Antifungal agent (pharmaceutical active, not a standard cosmetic function)
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Regulated as a drug ingredient (antifungal); not approved for over-the-counter cosmetic use; any product containing bifonazole would be classified as a drug

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

Harmful if swallowed (ATE oral = 500 mg/kg); acute toxicity category 4; skin sensitization potential in some individuals. Broad-spectrum imidazole antifungal; EC No. 262-336-6; effective against dermatophytes and yeasts but strictly a pharmaceutical active, not a cosmetic ingredient

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Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Bifonazole safe in cosmetics?

Harmful if swallowed (ATE oral = 500 mg/kg); acute toxicity category 4; skin sensitization potential in some individuals. Broad-spectrum imidazole antifungal; EC No. 262-336-6; effective against dermatophytes and yeasts but strictly a pharmaceutical active, not a cosmetic ingredient The EU classifies Bifonazole as "permitted". Safety rating: MODERATE.

Is Bifonazole allowed in the EU?

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

What does Bifonazole do in cosmetics?

Bifonazole functions as: Antifungal agent (pharmaceutical active, not a standard cosmetic function). It is classified as a cosmetic ingredient in our database. CAS number: 60628-96-8.

What is the Margin of Safety for Bifonazole?

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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