FDA label
What is azelaic acid used for?
The FDA-approved uses of azelaic acid, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use”
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Azelaic Acid, gel
Indications and Usage, quoted from the label by Encube Ethicals, Inc. (ANDA208724). Cross-references to other label sections are left out.
Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use
Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Source: DailyMed label, set id ab3f174c-a3c4-4ae9-b0bc-954efaadf8de, version 3, effective December 24, 2025. NDC 21922-038, one of 5 listings for this product.
Questions
What is azelaic acid used for?
The FDA label says: “Azelaic Acid Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use”
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.