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OTC Drug Only

Epsilon-aminocaproic acid

ε-アミノカプロン酸

US

Cosmetic/OTC/Rx

EU

Medicinal/Cosmetic

JP

Quasi-drug approved

KR

Functional cosmetic

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Data last updated 28 days ago. Regulatory status can change; verify with official sources before making compliance decisions.

CAS Number

60-32-2

Max Concentration

2.0%

Restriction Type

quasi drug

Category

quasi drug active

Pharmaceutical Class

Quasi-drug Active

Exact Legal Citations

Japan Ordinance

Ministry of Health, Labour and Welfare (MHLW) Quasi-Drug Standards

Regulatory Notes

Anti-plasmin; Japan quasi-drug whitening

Cross-Jurisdiction Status

US (FDA)

Cosmetic/OTC/Rx

EU (SCCS)

Medicinal/Cosmetic

Japan (MHLW)

Quasi-drug approved

Korea (MFDS)

Functional cosmetic

Drug-Cosmetic Boundary Note

Japan has a unique 'quasi-drug' category between cosmetic and drug. These ingredients require MHLW pre-approval and must meet specific efficacy standards. Same ingredient may be cosmetic in US but quasi-drug in Japan.

Cross-Market Regulatory Rules

1 rule from official sources

EU 1 rule
prohibited annex ii EU CosIng Annex Substances

as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0.1% by weight; Shall not be placed on the market, or used, as substance or in mixtures in concentrations equal to ot greater than 0.1% by weight

Warning: Regulations: (EC) 2009/1223

Citation ▼

EU CosIng Annex II / Ref 7

View official source →

Source Document

MHLW Standards for Cosmetics / Quasi-Drug Standards

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