Crotamiton

INCI: CROTAMITON

CAS Number
483-63-6
Function
Anti-pruritic agent, antimicrobial (primarily pharmaceutical — used as scabicide in OTC drugs)
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status permitted
US Notes FDA: Regulated as OTC drug active ingredient (anti-scabies); use in cosmetics would likely trigger drug classification

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
high
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

RED FLAG: This is a pharmaceutical active, not a cosmetic ingredient in practice. Systemic exposure concern; contact sensitization documented; if included in a cosmetic CPSR, the Safety Assessor must justify cosmetic vs. pharmaceutical classification. Not suitable for leave-on cosmetics without extensive justification

⚠️
Concern Level: High

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Crotamiton safe in cosmetics?

RED FLAG: This is a pharmaceutical active, not a cosmetic ingredient in practice. Systemic exposure concern; contact sensitization documented; if included in a cosmetic CPSR, the Safety Assessor must justify cosmetic vs. pharmaceutical classification. Not suitable for leave-on cosmetics without extensive justification The EU classifies Crotamiton as "prohibited". Safety rating: POOR.

Is Crotamiton allowed in the EU?

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

What does Crotamiton do in cosmetics?

Crotamiton functions as: Anti-pruritic agent, antimicrobial (primarily pharmaceutical — used as scabicide in OTC drugs). It is classified as a cosmetic ingredient in our database. CAS number: 483-63-6.

What is the Margin of Safety for Crotamiton?

adequate 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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