Moderate Cosmetic Ingredient

Miconazole Nitrate

INCI: MICONAZOLE NITRATE

CAS Number
22832-87-7
Function
Antimicrobial - helps control the growth of micro-organisms (bacteria and fungi)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status prohibited
US Notes Regulated as an OTC drug active ingredient (antifungal monograph, 21 CFR 333). Use in a cosmetic with antifungal claims would trigger drug classification. Not explicitly prohibited in cosmetics, but any antimicrobial/antifungal claim converts the product to 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

Azole antifungal with systemic pharmacological activity; skin sensitization potential; drug-cosmetic boundary issues; not intended for daily cosmetic use. Potential endocrine effects at high exposure. Broad-spectrum imidazole antifungal; active against dermatophytes, yeasts (Candida), and gram-positive bacteria. Its presence in a cosmetic formulation is a major regulatory red flag in both EU and US markets

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Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Miconazole Nitrate safe in cosmetics?

Azole antifungal with systemic pharmacological activity; skin sensitization potential; drug-cosmetic boundary issues; not intended for daily cosmetic use. Potential endocrine effects at high exposure. Broad-spectrum imidazole antifungal; active against dermatophytes, yeasts (Candida), and gram-positive bacteria. Its presence in a cosmetic formulation is a major regulatory red flag in both EU and US markets The EU classifies Miconazole Nitrate as "permitted". Safety rating: MODERATE.

Is Miconazole Nitrate allowed in the EU?

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

What does Miconazole Nitrate do in cosmetics?

Miconazole Nitrate functions as: Antimicrobial - helps control the growth of micro-organisms (bacteria and fungi). It is classified as a cosmetic ingredient in our database. CAS number: 22832-87-7.

What is the Margin of Safety for Miconazole Nitrate?

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 Miconazole Nitrate compliance across multiple jurisdictions:

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Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
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Substance Compliance
Check compliance across 55 jurisdictions
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
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Heavy Metal Limits
Compare limits across jurisdictions

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