FDA.reportPublic FDA data

Tolnaftate Antifungal Powder

Manufacturer
SCHOLL'S WELLNESS COMPANY LLC
Effective date
2025-12-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:20:30

Label at a glance#

ProductTolnaftate Antifungal Powder
Active ingredientTolnaftate
Label structure14 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

  • Clinically proven to prevent most athlete's foot (tinea pedis) with daily use

Warnings

WARNINGS SECTION

For External use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation occurs 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directios 

DOSAGE & ADMINISTRATION SECTION

  • to prevent athlete's foot, wash and dry feet thoroughly
  • apply a thin layer of the product on the feet once or twice daily (morning and/or night)
  • supervise children in the use of this product
  • pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily

Other Information

OTHER SAFETY INFORMATION

Store between 20° to 25°C (68° to 77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Chloroxylenol, Fragrance, Kaolin, Sodium Bicarbonate, Tricalcium Phosphate, Zea Mays (Corn) Starch, Zinc Oxide

Questions ?

OTC - QUESTIONS SECTION

1-866-360-3226

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABSCH001024F-0_98559_page-0001LABSCH001024F-0_98559_page-0001

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABSCH001024B-0_98559_page-0001LABSCH001024B-0_98559_page-0001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313422tolnaftate 1 % Topical PowderPSN2
313422tolnaftate 0.01 MG/MG Topical PowderSCD2
313422tolnaftate 1 % Topical PowderSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130888853004358GTIN-13: 0888853004358
EAN-13: 0888853004358
GTIN-12: 888853004358
UPC-A: 888853004358
GTIN storage (14 digits): 00888853004358		LABSCH001024B-0_98559_page-0001.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73469-0619-4Tolnaftate Antifungal Powder113 g in 1 BOTTLEPOWDER1132

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73469-061973469-0619-4

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
CHLOROXYLENOL0F32U78V2QIACT
KAOLIN24H4NWX5COIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
STARCH, CORNO8232NY3SJIACT
ZINC OXIDESOI2LOH54ZIACT

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
Tolnaftate Antifungal PowderTOLNAFTATESCHOLL'S WELLNESS COMPANY LLC2a0e006b-60b1-41b9-a5d2-ff0e34b48ff52025-12-06WarningsExact identifier
ndc (package): 73469-0619-4
ndc (product): 73469-0619
ndc11 (package): 73469061904
spl id: fee7a27d-f2f9-4d6f-920e-7ba0d39a4bea
spl set id: 2a0e006b-60b1-41b9-a5d2-ff0e34b48ff5

Reported adverse events (FAERS/openFDA)#

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