Econazole Nitrate is a prescription medicine. The sections below reproduce one FDA label for it, named under "Label". Products in other forms, strengths or from other makers have their own labels, which can differ.
- Type
- Prescription only (Rx)
- Brand names
- Ecoza
- Taken
- Topical
- Label
- Trifluent Pharma, LLC, revised October 31, 2025 · full label on DailyMed
- Generic
- FDA-approved (4 companies) · details
What it is used for
Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Econazole nitrate is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older. ( 1 )
Forms and strengths
Foam, 1%. Each gram of econazole nitrate topical foam, 1%, contains 10 mg of econazole nitrate in a white to off-white foam. Foam, 1%. ( 3 )
Who should not take it (contraindications)
None. None. ( 4 )
Warnings and precautions
– Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. ( 5.1 )
5.1 Flammability Econazole nitrate topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.
Side effects (adverse reactions)
– During clinical trials with econazole nitrate topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the econazole nitrate and vehicle arms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Trifluent Pharma at 1-800-927-5191 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 09/2025
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 two double-blind, vehicle-controlled clinical trials, 495 subjects were exposed to econazole nitrate topical foam or vehicle (246 subjects were exposed to econazole nitrate topical foam, 1% and 249 were exposed to vehicle). Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days. During clinical trials with econazole nitrate topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the econazole nitrate and vehicle arms.
Drug interactions
–
7.1 Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulant effect. Most cases reported product application with use under occlusion, genital application, or application to a large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.
Pregnancy, breastfeeding, children and older adults
–
8.1 Pregnancy – Pregnancy Category C There are no adequate and well-controlled trials with econazole nitrate topical foam in pregnant women. Econazole nitrate topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. Fetotoxic or embryotoxic effects were observed in Segment I oral studies with rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in Segment II or Segment III studies with mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.
8.3 Nursing Mothers It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.
8.4 Pediatric Use Of the 173 subjects treated with econazole nitrate topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old. In a pediatric maximal use trial, econazole nitrate topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see Clinical Pharmacology (12.3) ]. The safety findings for subjects 12 to 17 years were similar to those in adult population.
8.5 Geriatric Use Of the 173 subjects treated with econazole nitrate topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.
How it works
Econazole nitrate topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] .
Is there a generic Econazole Nitrate?
Yes. The FDA has approved generic Econazole Nitrate from 4 companies whose approvals are active. The earliest of these was approved in 2002.
An FDA approval does not always mean the generic is already in pharmacies: patent disputes and settlements can delay a launch for years. Your pharmacist can tell you whether a generic is actually available and covered by your plan.
The FDA rates these generics as therapeutically equivalent to the brand ("A" rating): same active ingredient, strength, dosage form and effect. Pharmacists can usually substitute them unless the prescriber says otherwise.
Companies with an approved generic
Aurobindo Pharma Usa, Encube, Padagis Israel, Sun Pharma Canada
Brand-name versions
- Spectazole Alvogen, approved 1982 Discontinued
- Ecoza Resilia Pharms, approved 2013
Source: Drugs@FDA (via openFDA), checked October 29, 2026. Marketing status is what companies report to the FDA; whether a pharmacy stocks a product, and what your insurance covers, can differ.
Dosage:
we do not reproduce dosing instructions. The right dose depends on the person and the condition and is set by the prescriber or pharmacist. Dosage section of the full label.
Econazole in the news
We have not covered this medicine yet. Latest news
Recalls
No recalls matched to this medicine in FDA enforcement reports from the last 3 years (or older ones still open). Search all recalls
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Source: FDA structured product labeling, retrieved through openFDA. Label text is shown as published by the FDA, without editing; long sections are shortened, marked […]. openFDA data are not validated for clinical use — always check the current label and ask a doctor or pharmacist about your own treatment. Set ID 3eb40c94-f369-ce4b-e063-6294a90abed4.