ADVERSE REACTIONS SECTION.

6 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 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.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION.

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies to determine the carcinogenic potential of econazole nitrate topical foam have not been performed.Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.

CLINICAL PHARMACOLOGY SECTION.

12 CLINICAL PHARMACOLOGY. -. 12.1 Mechanism of Action. Econazole nitrate topical foam is an azole antifungal see Clinical Pharmacology (12.4) . 12.2 Pharmacodynamics. The pharmacodynamics of econazole nitrate topical foam, 1% have not been established . 12.3 Pharmacokinetics. The systemic absorption of econazole nitrate topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects.In the adult trial, 19 subjects (male and female) with tinea pedis applied econazole nitrate topical foam, 1% once daily for 29 days. Subjects applied mean daily amount of 2.4 of econazole nitrate topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean +- SD) showed the time to reach peak plasma concentrations (T max) was 6.8 +- 5.1 with maximum concentration (C max) of 417 +- 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC (0-12)) was 3440 +- 1920 pg-h/ml. In the pediatric trial, 18 subjects (male and female ages 12 17) with interdigital tinea pedis and positive fungal cultures were treated with econazole nitrate topical foam, 1% once daily for weeks. Subjects applied mean daily amount of 3.2 of econazole nitrate topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and h and 11 post-dose. The mean +- SD econazole plasma concentration was 397 +- 289, 534 +- 745 and 575 +- 638 pg/mL at pre-dose and h and 11 post-dose, respectively.. 12.4 Microbiology. -. Mechanism of ActionEconazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition.. Activity in vitroand in clinical infections Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections see Indications and Usage (1) ]. Trichophyton rubrumEpidermophyton floccosumTrichophyton mentagrophytes.

CLINICAL STUDIES SECTION.

14 CLINICAL STUDIES. In two multi-center, randomized, double-blind, vehicle-controlled clinical trials total of 505 subjects with interdigital tinea pedis were randomized 1:1 to econazole nitrate topical foam or vehicle; subjects applied the assigned medication once daily for weeks. The severity of erythema, scaling, fissuring, maceration, vesiculation, and pruritus were graded using 4-point scale (none, mild, moderate, severe). Subjects had KOH examination and fungal cultures taken to confirm eligibility. total of 339 subjects with positive fungal cultures were evaluated for efficacy. Efficacy was evaluated on Day 43, weeks post-treatment with treatment success being defined as complete cure (negative KOH and fungal culture and no evidence of clinical disease). The study population ranged in age from 12 to 71 years with subjects less than 18 years of age at baseline. The subjects were 71% male and 51% Caucasian. Table presents the efficacy results for each trial.Table 1: Efficacy Results at Two Weeks Post-treatment (Day 43)Complete Cure, Effective Treatment and Mycological CureTrial 1Trial 2Econazole Nitrate topical foam 1%N 82n(%)Foam VehicleN 83n(%)Econazole Nitrate topical foam, 1%N 91n(%)Foam VehicleN 83n(%)Complete cure 19 (23.2%)2 (2.4%)23 (25.3%)4 (4.8%)Effective treatment 40 (48.8%)9 (10.8%)44 (48.4%)9 (10.8%)Mycological cure 56 (68.3%)13 (15.7%)61 (67.0%)15 (18.1%)aMycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus). bMycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent. cNegative KOH and fungal culture.

CLINICAL TRIALS EXPERIENCE SECTION.

6.1 Clinical Trials Experience. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of 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.

CONTRAINDICATIONS SECTION.

4 CONTRAINDICATIONS. None.. None. 4).

DESCRIPTION SECTION.

11 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 propellant. Each gram of econazole nitrate topical foam, 1% contains 10 mg of econazole nitrate, USP, in 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 18H 15Cl 3N 2O. HNO 3and molecular weight of 444.70. Its molecular structure is as follows: Chemical Structure.

DOSAGE & ADMINISTRATION SECTION.

2 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 weeks.. For topical use only; not for oral, ophthalmic, or intravaginal use. 2) Apply once daily for weeks. 2) For topical use only; not for oral, ophthalmic, or intravaginal use. 2) Apply once daily for weeks. 2).

DOSAGE FORMS & STRENGTHS SECTION.

3 DOSAGE FORMS AND STRENGTHS. Foam, 1%. Each gram of econazole nitrate topical foam, 1%, contains 10 mg of econazole nitrate in white to off-white foam.. Foam, 1%. 3).

DRUG INTERACTIONS SECTION.

7 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 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.

GERIATRIC USE SECTION.

8.5 Geriatric Use. Of the 173 subjects treated with econazole nitrate topical foam, 1% in the adult clinical trials, subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

HOW SUPPLIED SECTION.

16 HOW SUPPLIED/ STORAGE AND HANDLING. 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 20C to 25C (68F to 77F) with excursions permitted between 15C and 30C (59F and 86F). 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 120F (49C) even when empty.Do not store in direct sunlight.

INDICATIONS & USAGE SECTION.

1 INDICATIONS AND USAGE. Econazole nitrate topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes,and Epidermophyton floccosumin 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 floccosumin patients 12 years of age and older. 1).

INFORMATION FOR PATIENTS SECTION.

17 PATIENT COUNSELING 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 reaction suggesting sensitivity or chemical irritation develops with the use of econazole nitrate topical foam, 1%, use of the medication should be discontinued.. 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 reaction suggesting sensitivity or chemical irritation develops with the use of econazole nitrate topical foam, 1%, use of the medication should be discontinued.

INSTRUCTIONS FOR USE SECTION.

Instructions for Use Econazole Nitrate Topical Foam, 1%. Important information: econazole nitrate topical foam is for use on skin only.Do not use econazole nitrate topical foam in your eyes or vagina.Parts of econazole nitrate topical foam Canister. (See Figure A) Figure AHow to apply econazole nitrate topical foam:Step 1:Before you apply econazole nitrate topical foam, shake the econazole nitrate topical foam canister for about seconds.Step 2:Remove the cap and turn the econazole nitrate topical foam canister upside down over the palm of your hand.Step 3:Press down firmly on the actuator until there is small amount of foam about the size of golf ball in the palm of your hand. (See Figures Band C) Figure BFigure CStep 4:Use your finger-tips to scoop up small amounts of econazole nitrate topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin. (See Figure D) Figure DStep 5:You should apply econazole nitrate topical foam to your toes, to the spaces between your toes, and to the surrounding areas time day for weeks or as prescribed by your doctor.Step 6:Replace the cap. Wash your hands after applying econazole nitrate topical foam.How should store econazole nitrate topical foamStore econazole nitrate topical foam at room temperature, between 68F to 77F (20C to 25C).Do not refrigerate or freeze econazole nitrate topical foam.Do not store econazole nitrate topical foam in direct sunlight.Econazole nitrate topical foam is flammable. Keep the econazole nitrate topical foam canister away from heat and temperatures above 120F (49C), even if the canister is empty.Do not puncture or burn the econazole nitrate topical foam canister.Keep econazole nitrate topical foam and all medicines out of the reach of children.This Instructions for Use has been approved by the U.S. Food and Drug Administration.Manufactured for Trifluent Pharma, LLC, San Antonio, TX 78213Issued: 09/2025. Store econazole nitrate topical foam at room temperature, between 68F to 77F (20C to 25C).. Do not refrigerate or freeze econazole nitrate topical foam.. Do not store econazole nitrate topical foam in direct sunlight.. Econazole nitrate topical foam is flammable. Keep the econazole nitrate topical foam canister away from heat and temperatures above 120F (49C), even if the canister is empty.. Do not puncture or burn the econazole nitrate topical foam canister.. Container. Figure B. Figure C. Figure D.

MECHANISM OF ACTION SECTION.

12.1 Mechanism of Action. Econazole nitrate topical foam is an azole antifungal see Clinical Pharmacology (12.4).

MICROBIOLOGY SECTION.

12.4 Microbiology. -. Mechanism of ActionEconazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition.. Activity in vitroand in clinical infections Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections see Indications and Usage (1) ]. Trichophyton rubrumEpidermophyton floccosumTrichophyton mentagrophytes.

NONCLINICAL TOXICOLOGY SECTION.

13 NONCLINICAL TOXICOLOGY. -. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility. Long-term animal studies to determine the carcinogenic potential of econazole nitrate topical foam have not been performed.Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.

NURSING MOTHERS SECTION.

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 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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 70 Canister Label. NDC 73352-100-70Econazole nitrate topical foam, 1%For Topical Use OnlyNot for ophthalmic, oral or intravaginal use.Keep Out of Reach of ChildrenRx Only Net Wt 70g Label.

PEDIATRIC USE SECTION.

8.4 Pediatric Use. Of the 173 subjects treated with econazole nitrate topical foam, 1% in the clinical trials, subjects were 12 to 17 years old. In 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.

PHARMACODYNAMICS SECTION.

12.2 Pharmacodynamics. The pharmacodynamics of econazole nitrate topical foam, 1% have not been established.

PHARMACOKINETICS SECTION.

12.3 Pharmacokinetics. The systemic absorption of econazole nitrate topical foam, 1% following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects.In the adult trial, 19 subjects (male and female) with tinea pedis applied econazole nitrate topical foam, 1% once daily for 29 days. Subjects applied mean daily amount of 2.4 of econazole nitrate topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean +- SD) showed the time to reach peak plasma concentrations (T max) was 6.8 +- 5.1 with maximum concentration (C max) of 417 +- 218 pg/ml. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC (0-12)) was 3440 +- 1920 pg-h/ml. In the pediatric trial, 18 subjects (male and female ages 12 17) with interdigital tinea pedis and positive fungal cultures were treated with econazole nitrate topical foam, 1% once daily for weeks. Subjects applied mean daily amount of 3.2 of econazole nitrate topical foam, 1% to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and h and 11 post-dose. The mean +- SD econazole plasma concentration was 397 +- 289, 534 +- 745 and 575 +- 638 pg/mL at pre-dose and h and 11 post-dose, respectively.

PREGNANCY SECTION.

8.1 Pregnancy. -. Pregnancy Category CThere 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 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.

SPL PATIENT PACKAGE INSERT SECTION.

Patient Information Econazole nitrate topical foam, 1% Important information: Econazole nitrate topical foam is for use on skin only. Do not use Ecoza topical foam in your eyes or vagina. What is econazole nitrate topical foamEconazole nitrate topical foam is prescription medicine used on the skin (topical) to treat athletes foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older. What should tell my doctor before using Econazole nitrate topical foamBefore using econazole nitrate topical foam, tell your doctor about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if econazole nitrate topical foam will harm your unborn baby.are breastfeeding or plan to breastfeed. It is not known if econazole nitrate topical foam passes into your breast milk. Tell your doctor about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. How should use econazole nitrate topical foamSee the detailed Instructions for Usefor information about how to use econazole nitrate topical foam. Use econazole nitrate topical foam exactly as your doctor tells you to use it.Apply econazole nitrate topical foam to the affected skin areas of your feet time day for weeks.If econazole nitrate topical foam gets in or near your eyes, rinse them well with water.Wash your hands after you apply econazole nitrate topical foam. What should avoid while using econazole nitrate topical foamEconazole nitrate topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply econazole nitrate topical foam to your skin.What are the possible side effects of econazole nitrate topical foamEconazole nitrate topical foam may cause skin reactions at the treatment site. Tell your doctor if you have any skin reactions on the areas of your skin treated with econazole nitrate topical foam. These are not all the possible side effects of econazole nitrate topical foam. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should store econazole nitrate topical foamStore econazole nitrate topical foam at room temperature, between 68F to 77F (20C to 25C).Do not refrigerate or freeze econazole nitrate topical foam.Do not store econazole nitrate topical foam in direct sunlight.Econazole nitrate topical foam is flammable. Keep the econazole nitrate topical foam canister away from heat and temperatures above 120F (49C), even if the canister is empty.Do not puncture or burn the econazole nitrate topical foam canister.Keep econazole nitrate topical foam and all medicines out of the reach of children.General information about the safe and effective use of econazole nitrate topical foamMedicines are sometimes prescribed for purposes other than those listed in Patient Information leaflet. You can ask your doctor or pharmacist for information about econazole nitrate topical foam that is written for health professionals. Do not use econazole nitrate topical foam for condition for which it was not prescribed. Do not give econazole nitrate topical foam to other people, even if they have the same symptoms that you have. It may harm them. What are the ingredients in econazole nitrate topical foamActive ingredient:econazole nitrate USP Inactive Ingredients:dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as propellant. Manufactured for Trifluent Pharma, LLC, San Antonio, TX 78213 P/N 141384 For more information call Trifluent Pharma, LLC at 888927-5191 This Patient Information has been approved by the U.S. Food and Drug Administration.Issued: 9.2025. are pregnant or plan to become pregnant. It is not known if econazole nitrate topical foam will harm your unborn baby.. are breastfeeding or plan to breastfeed. It is not known if econazole nitrate topical foam passes into your breast milk.. Use econazole nitrate topical foam exactly as your doctor tells you to use it.. Apply econazole nitrate topical foam to the affected skin areas of your feet time day for weeks.. If econazole nitrate topical foam gets in or near your eyes, rinse them well with water.. Wash your hands after you apply econazole nitrate topical foam.. Econazole nitrate topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply econazole nitrate topical foam to your skin.. Store econazole nitrate topical foam at room temperature, between 68F to 77F (20C to 25C).. Do not refrigerate or freeze econazole nitrate topical foam.. Do not store econazole nitrate topical foam in direct sunlight.. Econazole nitrate topical foam is flammable. Keep the econazole nitrate topical foam canister away from heat and temperatures above 120F (49C), even if the canister is empty.. Do not puncture or burn the econazole nitrate topical foam canister.

SPL UNCLASSIFIED SECTION.

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 120F (49C) even when empty. Do not store in direct sunlight.

STORAGE AND HANDLING SECTION.

Store at controlled room temperature 20C to 25C (68F to 77F) with excursions permitted between 15C and 30C (59F and 86F). 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 120F (49C) even when empty.Do not store in direct sunlight.

TERATOGENIC EFFECTS SECTION.

Pregnancy Category CThere 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 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.

USE IN SPECIFIC POPULATIONS SECTION.

8 USE IN SPECIFIC POPULATIONS. -. 8.1 Pregnancy. -. Pregnancy Category CThere 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 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 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, subjects were 12 to 17 years old. In 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, subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

WARNINGS AND PRECAUTIONS SECTION.

5 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 120F (49C) even when empty. Do not store in direct sunlight.