FDA.reportPublic FDA data

Tolnaftate

Manufacturer
The Podiatree Company
Effective date
2017-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:06:16

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

Cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris) If used daily, can prevent recurrence of athlete's foot Relieves symptoms of athlete's foot, including itching, burning, and cracking

Dosage and administration

Wash affected area and dry thoroughly Shake can well and spray a thin layer over the 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch If c...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

​ ​Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • If used daily, can prevent recurrence of athlete's foot
  • Relieves symptoms of athlete's foot, including itching, burning, and cracking

​Warnings

WARNINGS SECTION

For external use only.

Flammable:

SPL UNCLASSIFIED SECTION

Do not use near heat or flame, or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120ºF.

​When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes or mouth
  • Use only as directed
  • Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

​Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

​Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

​Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash affected area and dry thoroughly
  • Shake can well and spray a thin layer over the 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 toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • Use daily for 4 weeks for athletes foot, ringworm; use daily for 2 weeks for jock itch
  • If conditions persist, consult a doctor
  • To prevent athlete's foot, apply daily (morning and night)
  • This product is not effective on the scalps or nails
  • In case of clogging, clear nozzle under running water

​Other information

OTHER SAFETY INFORMATION

Store between 20º and 30ºC (68ºF and 86ºF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

BHT, isobutane (propellent), PPG-12-buteth-16, SD alcohol 40-B (14%w/w), talc

Questions or Suggestions?

OTC - QUESTIONS SECTION

1.855.763.8733 or www.thepodiatreecompany.com. Our commitment to you is 100%

satisfaction. If you are not completely satisf ied, please contact us directly for a full refund.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54633-913-042025-11-24C16284748780-12cef2736-69a8-d83d-e063-dadaa90ab31f60b9aa2d-ae5c-567b-e053-2a91aa0a1e29
54633-913-042025-01-30C16284748780-12cef2736-69a8-d83d-e063-dadaa90ab31f60b9aa2d-ae5c-567b-e053-2a91aa0a1e29

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54633-913TOLNAFTATE (ANTIFUNGAL POWDER SPRAY) AEROSOL, POWDER [THE PODIATREE COMPANY]3Legacy NDC20171220_60b9aa2d-ae5c-567b-e053-2a91aa0a1e29.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54633-91354633-913-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
PPG-12-BUTETH-1658CG7042J1IACT
ALCOHOL3K9958V90MIACT
TALC7SEV7J4R1UIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
445d3e5e-4787-5cd6-e063-6394a90af7f260b9aa2d-ae5c-567b-e053-2a91aa0a1e292025-11-24WarningsExact identifier
spl set id: 60b9aa2d-ae5c-567b-e053-2a91aa0a1e29

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.