FDA.reportPublic FDA data

Liquid Antifungal Treatment

Manufacturer
Hudson Health LLC
Effective date
2025-10-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:40:55

Label at a glance#

ProductLiquid Antifungal Treatment
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

for the treatment of athlete’s foot (tinea pedis) and ringworm (tinea corporis) for effective relief of itching, scaling, cracking, burning and redness.

Dosage and administration

wash the affected area and dry thoroughly. apply a thin layer of the product 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. for athlete’s foot and ringworm, use daily for 4 weeks. if ...

Label contents#

Full prescribing information#

​Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

​Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

for the treatment of athlete’s foot (tinea pedis) and ringworm (tinea corporis)

for effective relief of itching, scaling, cracking, burning and redness.

Warnings

WARNINGS SECTION

For external use only.

Flammable

SAFE HANDLING WARNING SECTION

keep away from fire or flame.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

avoid contact with the eyes.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation occurs or if there is no improvement within 4 weeks

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 the affected area and dry thoroughly.
  • apply a thin layer of the product 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.
  • for athlete’s foot and ringworm, use daily for 4 weeks.
  • if condition persists longer, consult a doctor.
  • this product is not effective on the scalp or nails.

​Other information​

OTHER SAFETY INFORMATION

  • Store at room temperature 15°-30°C (59° - 86°F)
  • Keep tightly closed when not in use

​Inactive ingredient

INACTIVE INGREDIENT SECTION

Acetone, Water, Propylene Glycol, Tocopherol Acetate.

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncartonComfort zone

liquid antifungal treatment

with vitamin e to moisturize

TOLNAFTATE 1%/ANTIFUNGAL

Maxiumum Strength

Brush- On Applicator

SHAKE WELL BEFORE USE

1 FL. OZ. (30 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN3
313423tolnaftate 10 MG/ML Topical SolutionSCD3
313423tolnaftate 1 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72446-012-01Liquid Antifungal Treatment30 mL in 1 BOTTLE, WITH APPLICATORLIQUID303
72446-012-01Liquid Antifungal Treatment1 in 1 CARTONLIQUID13

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72446-01272446-012-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETONE1364PS73AFIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-10-15full-release2026-06-01 00:25:31

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
Liquid Antifungal TreatmentTOLNAFTATEHudson Health LLC14a9efd8-e49f-12fa-e063-6394a90aa8a02025-10-24WarningsExact identifier
ndc (package): 72446-012-01
ndc (product): 72446-012
ndc11 (package): 72446001201
spl id: 41eebed7-70e0-fc97-e063-6394a90a1027
spl set id: 14a9efd8-e49f-12fa-e063-6394a90aa8a0

Reported adverse events (FAERS/openFDA)#

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