FDA.reportPublic FDA data

Antifungal Cream Tolnaftate 1%

Manufacturer
Meijer | Trifecta Pharmaceuticals USA LLC
Effective date
2023-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:12

Label at a glance#

ProductAntifungal Cream Tolnaftate 1%
Active ingredientTOLNAFTATE
Label structure15 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) 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 pers...

Storage and handling

● store between 20° to 25°C ( 68° to 77°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

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 (1-800-222-1222) right away.

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.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes

Do Not Use

OTC - DO NOT USE SECTION

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

Stop Use and Ask a Doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks

If Pregnant or Breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If Pregnant or Breast-feeding ask a health professional before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

● wash affected area and dry thoroughly

● apply 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.

● for athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult 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.

Other information

STORAGE AND HANDLING SECTION

● store between 20° to 25°C ( 68° to 77°F)

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Distrubuted By Meijer Distribution, Inc.

Grand Rapids, MI 49544

www.meijer.com

Made in China

This product is not manufactured or distributed by Bayer Healthcare LLC, owner of the registered trademarks Tough Actin and Tinactin.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CDER-Meijer Tolnaftate creamCDER-Meijer Tolnaftate cream

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79481-0015-52025-01-30C16284748780-12cef2736-6214-d83d-e063-dadaa90ab31fMeijer Antifungal Cream Tolnaftate 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0015-5Antifungal Cream Tolnaftate 1%1 in 1 BOXCREAM12
79481-0015-5Antifungal Cream Tolnaftate 1%14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0015ANTIFUNGAL CREAM TOLNAFTATE 1% (TOLNAFTATE) CREAM [MEIJER]2Legacy NDC, 2 package rows20230112_c1211964-e814-4737-e053-2995a90a8d3e.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
79481-001579481-0015-5

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
CETYL ALCOHOL936JST6JCNIACT
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
f2026976-ae4a-a6ea-e053-2a95a90ae6acc1211964-e814-4737-e053-2995a90a8d3e2023-01-11WarningsExact identifier
spl id: f2026976-ae4a-a6ea-e053-2a95a90ae6ac
spl set id: c1211964-e814-4737-e053-2995a90a8d3e

Reported adverse events (FAERS/openFDA)#

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