Is Itraconazole safe in cosmetics?
Itraconazole has a safety rating of "MODERATE" in our database. EU status: prohibited. US status: permitted.
Moderate
Cosmetic Ingredient
Itraconazole
Also known as: BRN 6042047, Itraconazol, Itraconazolum, Hyphanox, Candistat (+2 more)
INCI: ITRACONAZOLE
Itraconazole (CAS 84625-61-6) is a cosmetic cosmetic ingredient functioning as Antifungal agent (pharmaceutical active). EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 84625-61-6 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Itraconazole is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Antifungal agent (pharmaceutical active)
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
2-butan-2-yl-4-[4-[4-[4-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-1,2,4-triazol-3-one
InChIKey
VHVPQPYKVGDNFY-ZPGVKDDISA-N
Regulatory Status
EU EU Status
prohibited
US US Status
permitted
US Notes
Not permitted for cosmetic use - Itraconazole is an FDA-approved prescription drug (brand name Sporanox); its inclusion in a "cosmetic" product would cause that product to be classified as a drug, requiring NDA/ANDA approval
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Itraconazole.
Calculate MoS for your specific formulation with the MoS Calculator.
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (1)
Skin Eye Respiratory Irritation
May cause irritation /upon inhalation/. Remove to fresh air. May cause /eye/ irritation. Flush with copious quantities of water. May cause irritation /to skin/. Flush with copious quantities of water.
Source: Hazardous Substances Data Bank (HSDB)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Expert Verdict
Expert safety assessment and concern-level summary for Itraconazole.
Known Synonyms
BRN 6042047
Itraconazol
Itraconazolum
Hyphanox
Candistat
Itrizole (TN)
Sporanox (TN)
Chemical Function
Biocide
Regulatory Lists
Canada; consumer_product; Substances in Products - Canada (4/2014)
pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
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
ITRACONAZOLE
ChEMBL ID
CHEMBL64391
Max Phase
4
Adverse Event Associations
1200
Frequently Asked Questions
Is Itraconazole allowed in the EU?
Itraconazole EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does Itraconazole do in cosmetics?
Itraconazole functions as: Antifungal agent (pharmaceutical active). It is classified as a cosmetic ingredient in our database. CAS number: 84625-61-6.
Is Itraconazole used outside cosmetics?
Itraconazole also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Itraconazole have different safety status in cosmetics vs industrial chemicals?
Itraconazole is prohibited in EU cosmetics but has active industrial GHS classifications (H302, H315, H319, H335).
Compliance Tools
Check Itraconazole 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 multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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