FDA label
What is Retin-A used for?
Retin-A contains tretinoin. 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 says: “RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.”
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Retin-A, cream
Indications and Usage, quoted from the label by Bausch Health US, LLC (NDA019049). Cross-references to other label sections are left out.
RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
Source: DailyMed label, set id 9556d73d-c573-4e0a-9feb-764ce2d1107b, version 15, effective May 17, 2024. NDC 0187-5160, one of 3 listings for this product.
Questions
What is Retin-A used for?
The FDA label says: “RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.”
What drug class is Retin-A?
FDA lists tretinoin in the Retinoid 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 Retin-A
- Is Retin-A a controlled substance?Federal schedule
- Generic for Retin-AFDA Orange Book
- What is Tretinoin used for?FDA label uses
- Is Tretinoin a controlled substance?Federal schedule
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- Retinoids listFDA drug class
- NDC 0187-5160Retin-A NDC record
- NDC 0187-5162Retin-A NDC record
- NDC 0187-5164Retin-A NDC record