FDA.reportPublic FDA data

Maximum Strength Antifungal Liquid

Manufacturer
FSA Store Inc.
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:41:03

Label at a glance#

ProductMaximum Strength Antifungal Liquid
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

For the treament of athlete's foot (tinea pedis) and ring worm (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 the 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 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% w/w

​Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the treament of athlete's foot (tinea pedis) and ring worm (tinea corporis).
  • For effective relief of itching, scaling, cracking, burning, and redness.

Warnings

WARNINGS SECTION

For external use only.

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 eyes.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • irritation occurs or if there is no improvement in 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.

Flammable

OTC - DO NOT USE SECTION

  • Keep away from fire or flame.

​Directions

DOSAGE & ADMINISTRATION SECTION

  • wash the affected area and dry thoroughly.
  • apply a thin layer of the product over the 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 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, Propylene Glycol, Tocopherol Acetate, Water.

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

caring mill

maximum strength

antifungal

liquid

tolnaftate 1%

Quick Drying Formula

Brush-on Applicator

NET 1 FL. OZ. (30 mL)

image 1image 1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN6
313423tolnaftate 10 MG/ML Topical SolutionSCD6
313423tolnaftate 1 % Topical SolutionSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-077-01Maximum Strength Antifungal Liquid30 mL in 1 BOTTLE, WITH APPLICATORLIQUID306
81522-077-01Maximum Strength Antifungal Liquid1 in 1 CARTONLIQUID16

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
81522-07781522-077-01

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
WATER059QF0KO0RIACT
TOCOPHEROLR0ZB2556P8IACT
TOLNAFTATE06KB629TKVACTIB
ACETONE1364PS73AFIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-08-15full-release2026-06-01 01:10:46

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
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
ndc (package): 81522-077-01
ndc (product): 81522-077
ndc11 (package): 81522007701
spl id: 422aad2b-03e5-01e3-e063-6394a90adb31
spl set id: fae36294-68b6-bf14-e053-6394a90aaacd

Reported adverse events (FAERS/openFDA)#

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