Athletes Foot
FDA Label NDC 63868-364

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Athletes Foot (NDC 63868-364). 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 other, active ingredient, purpose, uses, warnings, do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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Drug Facts

DISTRIBUTED BY QUALITY CHOICE
43157 WEST NINE MILE ROAD, NOVI, MI 48376-0995

Active Ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • 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
  • for vaginal yeast infections

Otc - When Using

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • too much irritation occurs or gets worse.
  • side effects occur.

Otc - Keep Out Of Reach Of Children

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 older
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.

        Figure (Terbinafine 01)

        Figure (Terbinafine 01)

      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.

        Figure (Terbinafine 02)

        Figure (Terbinafine 02)

      • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
      • wash hands after each use
      • children under 12 years: ask a doctor

Other Information

  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Questions?

Call 1-800-935-2362

Principal Display Panel - 15 G Tube Carton

QC
QUALITY
CHOICE®

Athlete's Foot Cream

Terbinafine Hydrochloride Cream 1%

Antifungal

NET WT 1/2 OZ (15 g )

Principal Display Panel (15 g Tube Carton)

Principal Display Panel (15 g Tube Carton)

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