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Sertaconazole: uses, dosing, side effects & brands

Sertaconazole is a medicine sold in the U.S. under one brand, for tinea pedis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Treats
Tinea Pedis
Available as
Topical
Sold as
Ertaczo
Prescription?
Prescription only
Generic available?
Not in our catalog

How sertaconazole is dosed

From the FDA label for Ertaczo (application NDA021385). Other sertaconazole products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Apply ERTACZO cream, 2% twice daily for 4 weeks. Apply a sufficient amount of ERTACZO cream, 2% to cover both the affected areas between the toes and the immediately surrounding healthy skin. Use ERTACZO cream, 2% for the full treatment time recommended by the physician, even though symptoms may have improved. Dry the affected area(s) thoroughly before application, if using ERTACZO cream, 2% after bathing. Wash hands after use. Avoid the use of occlusive dressings or wrappings. For topical use. Not for ophthalmic, oral, or intravaginal use. Apply ERTACZO cream, 2% to the affected and immediate surrounding area(s) twice daily for 4 weeks. ( 2 ) Not for ophthalmic, oral, or intravaginal use. ( 2 )

Sertaconazole side effects

Most common adverse reactions observed in clinical trials (incidence >2%) were contact dermatitis, dry skin, burning skin, application site skin tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, cutaneous adverse events occurred in 7 of 297 (2%) subjects (2 of them severe) receiving ERTACZO cream, 2%, and in 7 of 291 (2%) subjects (2 of them severe) receiving vehicle. These reported cutaneous adverse events included contact dermatitis, dry skin, burning skin, and application site skin tenderness. In a dermal sensitization trial, 8 of 202 evaluable subjects tested with ERTACZO cream, 2%, and 4 of 202 evaluable subjects tested with vehicle exhibited a erythematous reaction in the challenge phase. There was no evidence of cumulative irritation or contact sensitization in a repeated insult patch test involving 202 healthy volunteers. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of ERTACZO cream, 2%. Because…

Who shouldn’t take sertaconazole

None. None. ( 4 )

Every sertaconazole product we track (1)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Only one: Ertaczo.

What people report to the FDA about sertaconazole

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 131 reports naming sertaconazole, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

  • fatigue14 reports
  • urethral valves14 reports
  • fall13 reports
  • erythema10 reports
  • gait disturbance10 reports
  • rash10 reports
  • asthenia9 reports
  • dizziness9 reports

Read these as a signal, not a rate. A report does not mean sertaconazole caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved July 26, 2026.

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Frequently asked questions

What is sertaconazole?

ERTACZO (sertaconazole nitrate) cream, 2%, is for topical application. It contains the azole antifungal, sertaconazole nitrate. Sertaconazole nitrate contains one asymmetric carbon atom and exists as a racemic mixture of equal amounts of R and S enantiomers.

Can you take sertaconazole with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run sertaconazole against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What forms does sertaconazole come in?

Across the brands we track, sertaconazole is currently marketed as topical, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic sertaconazole?

We do not currently list a generic-labelled sertaconazole product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.

Cite this page
APA
pharmaranks. (2026, July 24). Sertaconazole: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/sertaconazole
MLA
“Sertaconazole: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/sertaconazole.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for sertaconazole on DailyMed (NIH) ↗.