Drug-cosmetic boundary, prescription concentrations 15-20% (EU/US); cosmetic claims at lower concentrations require careful wording; brightening anti-inflammatory keratolytic; generally well-tolerated; suitable for sensitive and rosacea-prone skin
Function & Common Use
Active (Brightening / Anti-acne / Keratolytic)
Active Ingredient
Acne and brightening serums
Vegetable (wheat/barley fermentation) / Synthetic
Concentration Limits
No formal limit
Cosmetic claims: review at >5%; drug boundary in EU/US at >20%
No specific 21 CFR cosmetic limit identified in source checked; EU limit reference: No
No specific MFDS limit identified in source checked; verify if ingredient is used in a Korean functional cosmetic category
Format restriction: Leave-on
Baby restriction: Pregnancy, considered generally safe but medical review recommended
Pregnancy: No specific restriction identified in source checked; standard cosmetic use
Frequently Asked Questions
Is Azelaic Acid safe to use in skincare?
Azelaic Acid has a Low concern rating from The Clean Sheet. Drug-cosmetic boundary, prescription concentrations 15-20% (EU/US); cosmetic claims at lower concentrations require careful wording; brightening anti-inflammatory keratolytic; generally well-tolerated; suitable for sensitive and rosacea-prone skin
Is Azelaic Acid allowed in India?
Azelaic Acid is currently classified as "Permitted" under Indian cosmetics regulations. The maximum permitted concentration is No formal limit.
What is Azelaic Acid used for in cosmetics?
Azelaic Acid functions as: Active (Brightening / Anti-acne / Keratolytic). It is commonly found in: Acne and brightening serums.
Is Azelaic Acid safe for babies?
Azelaic Acid has baby/child restrictions: Pregnancy, considered generally safe but medical review recommended. Avoid using products containing this ingredient on infants unless specifically formulated and labelled for baby use.
Regulatory Status
Permitted (drug-cosmetic boundary review required at high %)
Drug at >20% (prescription); cosmetic below
Cosmetic ingredient; standard TGA cosmetic framework applies; no therapeutic goods listing required unless therapeutic claims are made
Not specifically listed as restricted cosmetic ingredient in NHPID source checked; standard Health Canada cosmetic notification applies
EU Annex: EU Annex III (under review)
Identifiers
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Reviewed by The Clean Sheet, with our verdict.