Athletes Foot
FDA Label NDC 55910-007

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dolgencorp, Llc. for the product Athletes Foot (NDC 55910-007). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active IngredientPurpose

Tolnaftate 1% ................................................................ Antifungal

Otc - Purpose

Uses

  • cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • if used daily, can prevent recurrence of athlete's foot
  • relieves symptoms of athlete's foot, including itching, burning and cracking

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on children under 2 years of age unless directed by a doctor.

Indications & Usage

DG Health

Athlete's Foot Liquid Spray Tolnaftate 1% Antifungal

Compare to active ingredeint in Tinactin®*

Cures and prevents most athlete's foot

Relieves burning and itching

Net Wt 5.3oz (150g)

Warnings

Warnings

For external use only.

Flammable. Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120oF (49oC).

When using this product

  • avoid contact with eyes and face
  • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal

    • Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement after 4 weeks

Dosage & Administration

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • for athlete's foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once a day
  • use daily for 4 weeks; if condition persists longer, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and night)
  • this product is not effective on the scalp or nails

Inactive Ingredient

Inactive Ingredients

isobutane, alcohol denat. (29% w/w), propane, PPG-12-buteth-16, butylated hydroxytoluene

* Please review the disclaimer below.