Is tretinoin FDA-approved?

Yes, as specific products: Retin-A, Retin-A Micro, Atralin, Altreno, Renova and generic tretinoin creams and gels are FDA-approved for the uses in their labels, and they're prescription only.

Checked 1 Nov 2026. The sources are below.

Tretinoin

Also: Tretinoin (topical), Retin-A, Retin-A Micro, Renova, Altreno, Atralin, Avita, all-trans retinoic acid, retinoic acid, vitamin A acid

Status label in the Peptimes Library
FDA Approved
Routes in Peptimes
Topical
Updated
1 Nov 2026

US regulatory status

FDA approval belongs to each product below, for its route and the uses in its label. Label uses are shortened unless quoted.

  • Retin-A (tretinoin) cream and gel

    Topical

    Acne vulgaris.

    Source: DailyMed label, checked 1 Nov 2026

  • Retin-A Micro (tretinoin) gel

    Topical

    Acne vulgaris in adults and children aged 12 and older.

    Source: DailyMed label, checked 1 Nov 2026

  • Atralin (tretinoin) gel

    Topical

    Acne vulgaris.

    Source: DailyMed label, checked 1 Nov 2026

  • Altreno (tretinoin) lotion

    Topical

    Acne vulgaris in people aged 9 and older.

    Source: DailyMed label, checked 1 Nov 2026

  • Renova (tretinoin) cream

    Topical

    As an adjunctive agent "for use in the mitigation (palliation) of fine facial wrinkles" in people who use comprehensive skin care and sunlight avoidance programs. The label says it does not eliminate wrinkles or repair sun-damaged skin.

    Source: DailyMed label, checked 1 Nov 2026

  • Avita (tretinoin) cream and generic tretinoin creams and gels, from several manufacturers

    Topical

    As stated on each product's label (Avita through an NDA; the generics through abbreviated new drug applications, ANDAs).

    Source: Drugs@FDA, checked 1 Nov 2026

  • Prescription

    Prescription only. Drugs@FDA lists each product above as "Prescription".

    Source: Drugs@FDA, checked 1 Nov 2026

  • Investigational

    No, for the products and uses above.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • In humans

    In two 12-week randomised, double-blind trials in 1,640 people aged 9 and older with moderate or severe acne, more people were clear or almost clear with Altreno than with the plain lotion: 16.5% vs 6.9% in one trial and 19.8% vs 12.5% in the other.

    Source: Altreno label, NDA 209353, checked 1 Nov 2026

  • In humans

    Of five vehicle-controlled trials of Renova, two adequately showed an effect on fine facial wrinkles. None adequately showed an effect on coarse wrinkles, mottled pigmentation, skin roughness or laxity.

    Source: Renova label, NDA 021108, checked 1 Nov 2026

How to track it in Peptimes

Add tretinoin in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry, “Tretinoin (topical)”, shows the status label “FDA Approved”; the list above gives the detail by product.

  • Logging: the amount you applied and how you feel. It’s logged as topical, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

This page is about tretinoin applied to the skin. Tretinoin capsules taken by mouth are a different product and aren’t covered here.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell tretinoin or any other compound.

More sources

Brand names on this page are trademarks of their owners. Peptimes isn't affiliated with or endorsed by them.

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