Antifungal Foot Treatment
FDA Label NDC 83004-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Antifungal Foot Treatment (NDC 83004-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Butenafine hydrochloride 1%

Purpose

Antifungal

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

Warnings

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

● 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

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

Inactive Ingredients

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

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