FDA label
What is Opzelura used for?
Opzelura contains ruxolitinib. The FDA-approved uses below are 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 for Opzelura lists 2 uses: Atopic Dermatitis; Nonsegmental Vitiligo.
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Opzelura, cream
Indications and Usage, quoted from the label by Incyte Corporation (NDA215309). Cross-references to other label sections are left out.
Atopic Dermatitis
OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.
Nonsegmental Vitiligo
OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older.
Limitations of Use
Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended.
Source: DailyMed label, set id 24da5509-6631-4795-9d42-273faecd08e7, version 14, effective June 30, 2026. NDC 50881-007, one of 1 listing for this product.
Questions
What is Opzelura used for?
The FDA label for Opzelura lists 2 uses: Atopic Dermatitis; Nonsegmental Vitiligo.
What drug class is Opzelura?
FDA lists ruxolitinib in the Janus Kinase Inhibitor and Kinase Inhibitor established pharmacologic class.
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.
More on Opzelura
- Is Opzelura a controlled substance?Federal schedule
- Generic for OpzeluraFDA Orange Book
- Generic for Jakafi XRFDA Orange Book
- Generic for JakafiFDA Orange Book
- Janus Kinase Inhibitors listFDA drug class
- Kinase Inhibitors listFDA drug class
- Opzelura Medicare Part D coverageBy plan and state
- NDC 50881-007Opzelura NDC record