Antifungal Foot Treatment

Manufacturer
Rida LLC
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:40:42

Label at a glance#

ProductAntifungal Foot Treatment
Active ingredientBUTENAFINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. ● relieves itching, burning, cracking, and scaling which accompany these conditions

Dosage and administration

● adults and children 12 years and over:       ● wash the affected skin with the soap and water and dry completly before applying.       ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.       ● for athlete's foot between the toes : apply to affected skin between and around the toes twice a day for 1 week (morning and night), or          once a day for 4 weeks, or as dire...

Label contents#

Full prescribing information#

Active Ingredient                                                          

OTC - ACTIVE INGREDIENT SECTION

Butenafine hydrochloride 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

● cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown.
● relieves itching, burning, cracking, and scaling which accompany these conditions

Warnings

WARNINGS SECTION

For external use only


Do not use

  • on nails or scalp
  •  in or near the mouth or the eyes
  •  or vaginal yeast infections
  • When using this productdo not get into the eyes. If eye contact occurs, rinse thoroughly with water.
  • Stop use and ask a doctor iftoo much irritation occurs or irritation gets worse
  • Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

● adults and children 12 years and over:
      ● wash the affected skin with the soap and water and dry completly before applying.
      ● to open the applicator, twist the base to the ON position. Squeeze tube to dispence cream.

      ● for athlete's foot between the toes: apply to affected skin between and around the toes twice a day for 1 week (morning and night), or          once a day for 4 weeks, or as directed by a doctor. Wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.

  • Wipe applicator tip with a tissue and close the applicator by twisting the base to the OFF position
  • wash hands after each use.

Childern under 12 years: ask a doctor

Other Information 

SPL UNCLASSIFIED SECTION

● store between 20º to 25º C (68º to 77º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Tea Tree Oil, benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE, polyoxyethylene (23) cetyl ether, propylene glycol dicaprylate, purified water, sodium benzoate, stearic acid, trolamine, white petrolatum

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83004-016-012025-08-20C16284748780-13b156c62-2dad-fb37-e063-e6dba90a4e073a735ca5-4717-43a1-ab42-76f310bcfe00
83004-016-012025-07-29C16284748780-13b156c62-2dad-fb37-e063-e6dba90a4e073a735ca5-4717-43a1-ab42-76f310bcfe00

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83004-016ANTIFUNGAL FOOT TREATMENT (BUTENAFINE HYDROCHLORIDE) GEL [RIDA LLC]1Unmatched20250309_3a735ca5-4717-43a1-ab42-76f310bcfe00.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83004-01683004-016-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
52cf32e6-c512-6fa2-e063-6394a90adb973a735ca5-4717-43a1-ab42-76f310bcfe002026-05-27WarningsExact identifier
spl set id: 3a735ca5-4717-43a1-ab42-76f310bcfe00

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.