Tolnaftate Aerosol, Spray
FDA Label NDC 56104-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc. for the product Tolnaftate (NDC 56104-001). 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, ​flammable:, when using this product, ​stop use and ask a doctor if, ​keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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 temperature above 120°F

When Using This Product

  • avoid contact with the eyes or mouth
  • use only as directed

    • Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

​Stop Use And Ask A Doctor If

  • irritation occurs
  • no improvement within 4 weeks

​Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. ​Do not use​ on children under 2 years of age unless directed by a doctor.

​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 daily
  • use daily for 4 weeks
  • if conditions persist, consult a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails

​Other Information

store between 20° and 30°C (68°F and 86°)

​Inactive Ingredients

BHT, isobutane (propellant), PPG-12-buteth-16, SD alcohol 40-B(36%w/w)

Questions

Call 1-866-964-0939

​Principal Display Panel

Premier

Athlete's Foot

Antifungal Liquid Spray

Tolnaftate 1%

  • Cures and prevents most athlete's foot
  • Relieves itching & burning

    • For Athlete's Foot

    NET WT 5.3oz(150g)

    Principal Display Panel #2

    Premier

    Antifungal Liquid Spray

    Tolnaftate 1%

    • Cures and prevents most athlete's foot
    • Relieves itching & burning

      • For Athlete's Foot

      NET WT 5.3oz(150g)

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