Good Active Ingredient GHS Classified

Ketoconazole

INCI: KETOCONAZOLE

CAS Number
65277-42-1
Function
Antifungal drug active
Safety Rating
GOOD

Regulatory Status

🇪🇺 EU Status prohibited
🇺🇸 US Status prohibited
US Notes Classified as OTC drug (1% — Nizoral) or Rx drug (2%) in the US. Not a cosmetic ingredient; making anti-dandruff efficacy claims constitutes a drug claim requiring drug registration.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word
DANGER
Pictograms
skull;toxic; cancer;health haz; enviro;aqua
Hazard Statements
Toxic if swallowed May damage fertility or the unborn child Causes damage to endocrine system through prolonged or repeated exposure if swallowed Very toxic to aquatic life
Long-term Exposure Effects
The substance may have effects on the endocrine system and liver. Animal tests show that this substance possibly causes toxicity to human reproduction or development.
Routes of Exposure
The substance can be absorbed into the body by ingestion.

Expert Verdict

Ketoconazole is a drug ingredient, not permitted for cosmetic use in the US or EU. Any anti-dandruff efficacy claim triggers drug regulatory requirements in both jurisdictions.

⚠️
Concern Level: High

Regulatory Flags

drug-only not-cosmetic drug-cosmetic-boundary eu-medicinal eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Ketoconazole safe in cosmetics?

Ketoconazole is a drug ingredient, not permitted for cosmetic use in the US or EU. Any anti-dandruff efficacy claim triggers drug regulatory requirements in both jurisdictions. The EU classifies Ketoconazole as "prohibited". Safety rating: GOOD.

Is Ketoconazole allowed in the EU?

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

What does Ketoconazole do in cosmetics?

Ketoconazole functions as: Antifungal drug active. It is classified as a Active Ingredient in our database. CAS number: 65277-42-1.

What is the Margin of Safety for Ketoconazole?

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.

Is Ketoconazole classified as hazardous under GHS?

Ketoconazole carries a GHS signal word of "DANGER". Hazard statements: Toxic if swallowed May damage fertility or the unborn child Causes damage to endocrine system through prolonged or repeated exposure if swallowed Very toxic to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.

Compliance Tools

Check Ketoconazole compliance across multiple jurisdictions:

🔬
Ingredient Decoder
Paste a full ingredient list for instant analysis
 🌸
82 Allergen Checker
Check for EU declarable fragrance allergens
 🧪
Substance Compliance
Check compliance across 55 jurisdictions
 🧮
MoS Calculator
Calculate Margin of Safety using SCCS methodology
 ⚗️
Heavy Metal Limits
Compare limits across jurisdictions

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