Econazole Nitrate
Cream · Topical
Uses
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 )
Dosage and administration
Econazole nitrate topical foam, 1% is for topical use only. Econazole nitrate topical foam, 1% is not for oral, ophthalmic, or intravaginal use. Econazole nitrate topical foam, 1% should be applied to cover affected areas once daily for 4 weeks. For topical use only; not for oral, ophthalmic, or intravaginal use. ( 2 ) Apply once daily for 4 weeks. ( 2 )
Dosage 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 )
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
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.
Use in specific populations
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.
Pregnancy
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.
Pediatric use
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.
Geriatric use
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.
Description
Econazole nitrate topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base consisting of the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant. Each gram of econazole nitrate topical foam, 1% contains 10 mg of econazole nitrate, USP, in a white to off-white foam. Econazola nitrate topical foam, 1% is alcohol (ethanol)-free and for topical use only. Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl) ethyl]-1H-imidazole mononitrate. Econazole nitrate has the molecular formula C 18 H 15 Cl 3 N 2 O. HNO 3 and a molecular weight of 444.70. Its molecular structure is as follows: Chemical Structure
Mechanism of action
12.1 Mechanism of Action Econazole nitrate topical foam is an azole antifungal [ see Clinical Pharmacology (12.4) ] .
How supplied
Econazole nitrate topical foam, 1% is white to off-white foam supplied in 70g (NDC 73352-100-70) aluminum pressurized canister. Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. 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.
Storage
Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. 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.
Patient information
See FDA-approved patient labeling (Patient Information) The patient should be instructed as follows: Inform patients that econazole nitrate topical foam, 1% is for topical use only. Econazole nitrate topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use. Econazole nitrate topical foam, 1% is flammable; avoid heat, flame, and smoking during and immediately following application. If a reaction suggesting sensitivity or chemical irritation develops with the use of econazole nitrate topical foam, 1%, use of the medication should be discontinued.
Label text from the FDA structured product label by Trifluent Pharma, LLC (revised Oct 31, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Econazole Nitrate in 12 products
Econazole Nitrate NDC products (12)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 59651-945 | Econazole Nitrate 10 mg/g Cream | Aurobindo Pharma Limited | ANDA |
| 63629-8645 | Econazole Nitrate 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8646 | Econazole Nitrate 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8647 | Econazole Nitrate 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-1410 | Econazole Nitrate 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 21922-111 | Econazole Nitrate 10 mg/g Cream | Encube Ethicals, Inc. | ANDA |
| 45802-466 | Econazole Nitrate 10 mg/g Cream | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 68788-8170 | Econazole Nitrate 10 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8174 | Econazole Nitrate 10 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8884 | Econazole Nitrate 10 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 51672-1303 | Econazole Nitrate 10 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 73352-100 | Econazole Nitrate 10 mg/g Aerosol, Foam | Trifluent Pharma, LLC | NDA AUTHORIZED GENERIC |
Frequently asked questions
What is Econazole Nitrate 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…
What are the side effects of Econazole Nitrate?
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… See the full label for the complete list.
Who makes Econazole Nitrate?
Econazole Nitrate is listed by 7 labelers in the FDA NDC directory, including Aurobindo Pharma Limited, Bryant Ranch Prepack, Encube Ethicals, Inc., Padagis Israel Pharmaceuticals Ltd.