FDA.reportPublic FDA data

Athlete's Foot Cream Antifungal Cream

Manufacturer
Dollar General | Natureplex LLC
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:21

Label at a glance#

ProductAthletes Foot Antifungal
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

prevents the recurrence of most athlete's foot with daily use relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in 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 this product is not effective on scalp or nails

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

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

  • prevents the recurrence of most athlete's foot with daily use
  • relieves itching, burning, cracking, scaling, and discomfort that accompany these conditions

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

For external use only.

Avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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: 800-222-1222.

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 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
  • this product is not effective on scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions or comments?

OTC - QUESTIONS SECTION

1-888-309-9030

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY OLD EAST MAIN CO.,
100 MISSION RIDGE
GOODLETTSVILLE, TN 37072

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DG™| health

Compare to the active
ingredient of TINACTIN®*

Athlete's Foot Cream
Antifungal Cream

NET WT 1 OZ (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
103951tolnaftate 1 % Topical CreamPSN3
103951tolnaftate 10 MG/ML Topical CreamSCD3
103951tolnaftate 1 % Topical CreamSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55910-341-242025-07-02C16284748780-12cef2736-7806-d83d-e063-dadaa90ab31fAthlete's Foot Cream Antifungal Cream
55910-341-242025-01-30C16284748780-12cef2736-7806-d83d-e063-dadaa90ab31fAthlete's Foot Cream Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-341-24Athletes Foot Antifungal1 in 1 CARTONCREAM13
55910-341-24Athletes Foot Antifungal28 g in 1 TUBECREAM283

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-34155910-341-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
CETETH-20I835H2IHHXIACT
CETYL ALCOHOL936JST6JCNIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
STEARYL ALCOHOL2KR89I4H1YIACT

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
Athletes Foot AntifungalTOLNAFTATEDollar General43fc473e-c1fd-4245-af38-2e9de5ad91dc2025-07-02WarningsExact identifier
ndc (package): 55910-341-24
ndc (product): 55910-341
ndc11 (package): 55910034124
spl id: 8bbc299c-34fc-4615-a8da-87194ef11533
spl set id: 43fc473e-c1fd-4245-af38-2e9de5ad91dc

Reported adverse events (FAERS/openFDA)#

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