Quick answers
- What is Sertaconazole nitrate used for?
- The FDA-approved label (Ertaczo, Coral Way Pharma, LLC, April 7, 2026) says: “ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sertaconazole nitrate 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 Sertaconazole nitrate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sertaconazole nitrate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sertaconazole nitrate?
- 2 companies list prescription products of Sertaconazole nitrate in the FDA NDC Directory, including Coral Way Pharma, LLC and Lacer Pharma, LLC.
What Sertaconazole nitrate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ERTACZO ® cream, 2%, is indicated for the topical treatment of interdigital tinea pedis in immunocompetent adult and pediatric patients 12 years of age and older caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum. …
— FDA label: Ertaczo, Coral Way Pharma, LLC, effective April 7, 2026. 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 | Ertaczo |
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.
- Coral Way Pharma, LLC1 product
- Lacer Pharma, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021385 ERTACZO | Lacer Pharma | December 10, 2003 | 3, latest December 17, 2020 2020: Labeling · 2014: Labeling · 2005: Manufacturing (CMC) |
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) | 250511, 580294 |
|---|---|
| SPL set ID of the quoted label | c6fa8dc4-2620-474e-a9b4-6657d9cbfa96 |
| FDA labels (SPL) | 2 |
| FDA applications | NDA021385 |
| Active ingredients (FDA) | SERTACONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ertaczo, Coral Way Pharma, LLC, effective April 7, 2026; 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 →