FDA.reportPublic FDA data

Leader Tolnaftate Antifungal Powder Spray - Talc-Free

Manufacturer
LEADER/ Cardinal Health 110, Inc.
Effective date
2026-10-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
daily-update
Hydrated at
2026-10-13 04:04:33

Label at a glance#

ProductTolnafate
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

cures most athlete’s foot (tinea pedis), ringworm (tinea corporis), and jock itch (tinea cruris) can prevent recurrence of most athlete’s foot relieves symptoms of athlete’s foot, including itching, burning, cracking, and chafing associated with jock itch

Dosage and administration

wash affected area and dry thoroughly shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor 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 for athlete’s foot and ringworm; use daily...

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)
  • can prevent recurrence of most athlete’s foot
  • relieves symptoms of athlete’s foot, including itching, burning, cracking, and chafing associated with jock itch

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Do not use

OTC - DO NOT USE SECTION

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

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night) or as directed by a doctor
  • 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 for athlete’s foot and ringworm; use daily for 2 weeks for jock itch
  • if condition persists, consult a doctor
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

Antifungal

Athlete's Foot

Powder Spray

Tolnaftate 1 % | Antifungal

Cure Most Athlete's Foot

and Prevents Recurrences

Relieves Itching, Cracking,

and Burning

Talc- Free

4.6 OZ (130 g)

Leader_Antifungal Tolnaftate Powder Spray Talc-Free_50-060LD.jpgLeader_Antifungal Tolnaftate Powder Spray Talc-Free_50-060LD.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0322-1GM - Gram70000-03224b60f4b3-d93c-4c00-b163-d5ef22e10cee12019-03-12

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-032270000-0322-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
KAOLIN24H4NWX5COIACT
PPG-12-BUTETH-1658CG7042J1IACT
ALCOHOL3K9958V90MIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-12-31full-release2026-06-01 01:30:29
92025-10-08monthly-update2026-06-03 17:37:58
82024-11-01full-release2026-06-01 00:33:27

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
47436c2b-b78a-e8b3-e063-6294a90a479fa9fdd129-9909-4747-bd9f-93a204b507242025-12-31WarningsExact identifier
spl set id: a9fdd129-9909-4747-bd9f-93a204b50724

Reported adverse events (FAERS/openFDA)#

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