Tolnafate Aerosol, Spray
FDA Label NDC 63941-541

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Valu Merchandisers, Co for the product Tolnafate (NDC 63941-541). 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. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

When Using This Product

do not get into eyes or mouth, if products get into eyes, rinse eyes thoroughly with water
use only as directed

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)in case of clogging, clear nozzle under running water

Other Information

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

Inactive Ingredients

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

call 1-866-964-0939

Principal Display Panel

Best Choice

Athlete's Foot 

ANTIFUNGAL

POWDER SPRAY

  • Cures most athlete's foot and prevents recurrences
  • Relieves itching, cracking and burning 
  • Talc - Free

    • NET WT 4.6 OZ (130 g)

* Please review the disclaimer below.