Tolnaftate Aerosol, Spray
FDA Label NDC 11822-0782

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Tolnaftate (NDC 11822-0782). 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, ​do not use, 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 jock itch (tinea cruris)
  • relieves itching, burning and chafing associated with jock itch

​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 above 120°F. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

​When Using This Product

  • avoid contact with eyes
  • use only as directed

​Stop Use And Ask A Doctor If

  • irritation occurs
  • no improvement within 2 weeks

​Do Not Use

  • on children under 2 years of age unless directed by a doctor.

​Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

​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
  • use daily for 2 weeks; if conditions persists, consult a doctor
  • if nozzle clogs, clean with a pin

​Other Information

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

​Inactive Ingredient

BHT, isobutane, kaolin, PPG-12-buteth-16, SD alcohol 40-B, zea mays (corn) starch

Questions?

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