FDA.reportPublic FDA data

meijer

Manufacturer
Meijer Distribution Inc | Sun Pharma Canada Inc.
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:06:20

Label at a glance#

Productmeijer antifungal
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 condition persists longer, ask a doctor to prevent athlete's foot, apply once or twi...

Storage and handling

store between 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

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

Do not use

OTC - ASK DOCTOR 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 ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

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.

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 condition 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

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25°C (68° to 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, polyethylene glycol 400, polyethylene glycol 3350, titanium dioxide, white petrolatum

Questions?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DIST. BY MEIJER
DISTRIBUTION, INC.GRAND RAPIDS,
MI 49544
www.meijer.com
Made in Canada

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton-01carton-01meijer™

Cures & Prevents Most Athlete's Foot

AntifungalCream
Tolnaftate 1% Cream

NET WT 0.5 OZ (15 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN6
103951tolnaftate 10 MG/ML Topical CreamSCD6
103951tolnaftate 1 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-499-012023-11-27C16284748780-19d75b9d0-b440-f424-e053-dadaa90a57cemeijer ™ antifungal
41250-499-012020-01-31C16284748780-19d75b9d0-b440-f424-e053-dadaa90a57cemeijer ™ antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-499-01meijerantifungal1 in 1 CARTONCREAM16
41250-499-01meijerantifungal15 g in 1 TUBECREAM156
41250-499-02meijerantifungal30 g in 1 TUBECREAM306
41250-499-02meijerantifungal1 in 1 CARTONCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKV1
TolnaftateACTIVE MOIETY06KB629TKV1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
petrolatumINACTIVE INGREDIENT4T6H12BN9U1
polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5P1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQ1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-49941250-499-01, 41250-499-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PETROLATUM4T6H12BN9UIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
petrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
polyethylene glycol 3350POLYETHYLENE GLYCOL 3350G2M7P15E5PCREAM / TOPICAL396 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
Polyethylene glycol 400POLYETHYLENE GLYCOL 400B697894SGQCREAM / TOPICAL10 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPCREAM / TOPICAL80 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
meijer antifungalTOLNAFTATEMeijer Distribution Inc374af35a-b8bb-4784-bfc8-c3342de875ca2025-07-02WarningsExact identifier
ndc (package): 41250-499-01
ndc (package): 41250-499-02
ndc (product): 41250-499
ndc11 (package): 41250049901
ndc11 (package): 41250049902
spl id: 38f991cb-366e-1ce2-e063-6394a90ace1d
spl set id: 374af35a-b8bb-4784-bfc8-c3342de875ca

Reported adverse events (FAERS/openFDA)#

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