Quick answers
- What is Luliconazole used for?
- The FDA-approved label (Luzu, Bausch Health US, LLC, April 1, 2020) says: “LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Luliconazole have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Luliconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Luliconazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Luliconazole?
- 2 companies list prescription products of Luliconazole in the FDA NDC Directory, including Bausch Health US, LLC and Oceanside Pharmaceuticals.
What Luliconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
LUZU (luliconazole) Cream, 1% is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum. …
— FDA label: Luzu, Bausch Health US, LLC, effective April 1, 2020. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream |
|---|---|
| Route | Topical |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Luzu |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bausch Health US, LLC1 product
- Oceanside Pharmaceuticals1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA204153 LUZU | Bausch | November 14, 2013 | 4, latest February 20, 2018 2018: Efficacy · 2018: Efficacy · 2017: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1482684, 1482689 |
|---|---|
| SPL set ID of the quoted label | a7016010-ce43-4c09-8d21-aeb697ffed31 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA204153 |
| Active ingredients (FDA) | LULICONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Luzu, Bausch Health US, LLC, effective April 1, 2020; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →