Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

Inclusion Criteria:

- Willing & able to provide & understand written informed consent

- Healthy male or non-pregnant, non-lactating female at least 18 years of age and older

- Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces
or that is predominantly interdigital but may extend to other areas

- Tinea pedis provisionally confirmed at baseline by positive KOH wet mount preparation
showing segmented fungal hyphae

- Has sum of the clinical signs and symptoms scores of the target lesion of at least 4,
including a minimum score of 2 for erythema & a minimum score of 2 for scaling or
pruritus

- Currently in general good health with no clinically significant disease

- Willing and able to understand and comply with study requirements

- Women of childbearing potential must have a negative urine pregnancy test and be
willing to use an acceptable form of birth control during study

Exclusion Criteria:

- Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use
an acceptable form of birth control during the study

- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface

- Presence of any other infection of the foot or other disease that might confound
treatment evaluation

- History of dermatophyte infections unresponsive to antifungal drugs

- Known hypersensitivity to Butenafine HCl or any component of the study medications

- Use of antipruritics, topical systemic corticosteroid, antibiotic or antifungal
therapy, oral terbinafine or itraconazole, or immunosuppressive medication or
radiation therapy more recently than indicated washout period

- Current oral, vaginal, or mucocutaneous candidiasis

- Current bacterial skin infection, secondary cellulitis, lymphangitis, or pyoderma

- Presence of current conditions that require systemic antimicrobial or antifungal
therapy

- Uncontrolled diabetes mellitus, peripheral vascular disease, chronic venous stasis,
or other significant condition

- Current severe onychomycosis

- Any clinically significant condition or situation, other than condition being
studied, that would interfere with the study evaluations or participation

- Use of any investigational drugs or device within 30 days of signing ICF

- Current participation in any other clinical study

- Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would
compromise compliance

- Previous participation in this study

- Subjects with past history of tinea pedis with lack of response to antifungal therapy

- Subjects who in Investigator's opinion would be non-compliant

- Employees or direct relatives of an employee of the study center or Investigator