FDA.reportPublic FDA data

Tolnaftate

Manufacturer
Trifecta Pharmaceuticals USA, LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:32

Label at a glance#

ProductTolnaftate
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Dosage and administration

● wash affected area and dry thoroughly ● apply a thin layer over 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 the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily. ● use daily for 4 weeks; if conditions persists longer, ask a doctor. ● to prevent athlete's foot, app...

Storage and handling

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Fungal

Uses

INDICATIONS & USAGE SECTION

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

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

Warnings

WARNINGS SECTION

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if● irritation occurs ● there is no improvement within 4 weeks

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

● wash affected area and dry thoroughly

● apply a thin layer over 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 the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.

● use daily for 4 weeks; if conditions persists longer, ask a doctor.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Questions

OTC - QUESTIONS SECTION

Call 1-800-883-0085

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Other information

STORAGE AND HANDLING SECTION

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Distrubuted by

SPL UNCLASSIFIED SECTION

Proudly distributed by

Associated Wholesale Grocers Inc

Kansas City, Kansas 66106

Tinactin® is a registered trademark of Bayer Inc.

www.bestchoicebrand.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice Tolnaftate Cream 1oz 050923 CDERBest Choice Tolnaftate Cream 1oz 050923 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN2
103951tolnaftate 10 MG/ML Topical CreamSCD2
103951tolnaftate 1 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-130-01Tolnaftate1 in 1 BOXCREAM12
69396-130-01Tolnaftate28.3 g in 1 TUBECREAM28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-130TOLNAFTATE (TOLNAFTATE 1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC]2Current NDC, 2 package rows20250101_091b907f-544a-86c9-e063-6294a90a5d87.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-13069396-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CETYL ALCOHOL936JST6JCNIACT
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
TolnaftateTOLNAFTATE 1%Trifecta Pharmaceuticals USA, LLC091b907f-544a-86c9-e063-6294a90a5d872024-12-31WarningsExact identifier
ndc (package): 69396-130-01
ndc (product): 69396-130
ndc11 (package): 69396013001
spl id: 2a923ecc-8dad-73b1-e063-6394a90a7022
spl set id: 091b907f-544a-86c9-e063-6294a90a5d87

Reported adverse events (FAERS/openFDA)#

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