Is Ketoconazole safe in cosmetics?
Ketoconazole has a safety rating of "GOOD" in our database. EU status: prohibited. US status: prohibited.
Ketoconazole
Also known as: Piperazine, 1-acetyl-4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, rel-, (+/-)-Ketoconazole, cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazole-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, Ethanone, 1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]-, rel-, Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, cis- (+7 more)
INCI: KETOCONAZOLE
Ketoconazole (CAS 65277-42-1) is a cosmetic active ingredient functioning as Antifungal drug active. EU Regulation 1223/2009 status: prohibited; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 65277-42-1 →
Auto-generated CPSR Part A draft with source citations
Function
Antifungal drug active
Safety Rating
GOOD
Regulatory Status
EU EU Status
prohibited
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ketoconazole.
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
SkullToxicCancerHealth hazEnviroAqua
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.
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Health HazardAcute ToxicityEnvironmental Hazard
Hazard Class and Category
Repr. 1B; Acute Tox. 3 *; STOT RE 2 *; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
- H360F ***
- H301 Toxic if swallowed
- H373 **
- H400 Very toxic to aquatic life
- H410 Very toxic to aquatic life with long lasting effects
Inserted via ATP: ATP01
EU CosIng Annex Listing
European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.
Annex II — Prohibited
Ref: 1528
(EU) 2019/831
CMR: Reprotoxic Cat. 1B()
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1528
BRIN Brazil/India Cosmetics
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | banned | - | - |
| BR | restricted | 1 | Anti-dandruff products only |
| KR | prohibited | - | - |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Antidandruff Shampoo | 1–2 | 2 | FDA |
Additional Ingredient Properties
5 property records from structured ingredient metadata.
acne
{"cas_number": "65277-42-1", "anti_acne_mechanism": "antibacterial", "comedogenicity_rating_0_to_5": "0", "acne_type_efficacy": "fungal", "p_acnes_mic_ug_per_ml": "Variable", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "Yes", "otc_drug_monograph_category": "No", "rx_only_concentration_pct": "2", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu…
concentration
{"min_concentration_pct": "1.0", "max_concentration_pct": "2.0", "typical_concentration_pct": "1.0", "product_type": "Shampoo", "function_at_concentration": "Antifungal, anti-dandruff", "source": "FDA approved (OTC 1%)"}
hair_care
{"hair_function": "anti-dandruff", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "unknown", "color_safe": "neutral", …
hair_conditioning
{"cas_number": "65277-42-1", "ingredient_class": "anti_dandruff", "chemical_type": "other", "substantivity_to_hair": "poor", "deposition_from_shampoo": "yes", "deposition_from_conditioner": "yes", "conditioning_mechanism": "antifungal_pharmaceutical", "hair_penetration": "scalp_surface_deep", "molecular_weight_effect_on_penetration": "azole_antifungal_strong", "cuticle_smoothing": "no", "18_MEA_re…
uv_stability
{"uv_stable": "yes", "uv_degradation_rate": "stable", "photosensitizer": "no", "phototoxic": "no", "photoallergic": "no", "requires_uv_protection_packaging": "no", "color_change_uv": "no", "odor_change_uv": "no", "efficacy_loss_uv_pct": "0", "spf_contribution": "no", "uva_protection": "no", "uvb_protection": "no", "photostable_sunscreen": "no", "boost_spf_of_others": "no", "antioxidant_under_uv": …
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-dandruff
Regulatory List Membership (2)
EU Banned in Cosmetics
EU CosIng Cosmetics Ingredient Database
Expert Verdict
Expert safety assessment and concern-level summary for Ketoconazole.
Regulatory Flags
drug-only
not-cosmetic
drug-cosmetic-boundary
eu-medicinal
eu_banned_cosmetics
eu_cosing_listed
Known Synonyms
Piperazine, 1-acetyl-4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-, rel-
(+/-)-Ketoconazole
cis-1-Acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazole-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
Ethanone, 1-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]-, rel-
Piperazine, 1-acetyl-4-(4-((2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl)methoxy)phenyl)-, cis-
BRN 4303081
EINECS 265-667-4
Xolegel
Ketozole
Nizoral A-D
Ketoconazolum
UNII-R9400W927I
Chemical Function
Anti-dandruff
Regulatory Lists
pharmaceutical
pharmaceutical
Europe; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care - hair styling and care - shampoo-dandruff
banned; Europe; Personal care
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
KETOCONAZOLE
ChEMBL ID
CHEMBL157101
Max Phase
4
Adverse Event Associations
592
Frequently Asked Questions
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.
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.
Is Ketoconazole used outside cosmetics?
Ketoconazole also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Ketoconazole compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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