FDA.reportPublic FDA data

WINCO ANTIFUNGAL

Manufacturer
WinCo Foods LLC
Effective date
2024-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:38:19

Label at a glance#

ProductWINCO ANTIFUNGAL
Active ingredientTOLNAFTATE
Label structure11 sections

Indications and uses

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis). Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 the spaces between the toes. Wear well fitting ventilated shoes. Change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. ...

Label contents#

Full prescribing information#

Active 

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% 

Purpose 

OTC - PURPOSE SECTION

Antifungal 

Uses 

INDICATIONS & USAGE SECTION

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings 

WARNINGS SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over the 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 the spaces between the toes.
  • Wear well fitting ventilated shoes.
  • Change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks.
  • For jock itch, use daily for 2 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other Information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.

Inactives 

INACTIVE INGREDIENT SECTION

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Questions ?

OTC - QUESTIONS SECTION

1-800-222-1087

Principal Display panel -Carton 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WINCO                                    NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%) 

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

557175_Winco_1oz_Tolnaftate_Carton.jpg557175_Winco_1oz_Tolnaftate_Carton.jpg

Principal Display Panel -Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WINCO NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

255125_Winco_1oz_Tolnaftate_Tube.jpg255125_Winco_1oz_Tolnaftate_Tube.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-051-28WINCO ANTIFUNGAL28 g in 1 TUBECREAM283
67091-051-28WINCO ANTIFUNGAL1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-051WINCO ANTIFUNGAL (TOLNAFTATE 1%) CREAM [WINCO FOODS LLC]3Current NDC, Legacy NDC, 2 package rows20241122_46b58c71-d62e-4b3d-b2ec-65407032eeea.zip

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
67091-05167091-051-28

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
TOLNAFTATE06KB629TKVACTIB
CETETH-20I835H2IHHXIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
WATER059QF0KO0RIACT

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
WINCO ANTIFUNGALTOLNAFTATE 1%WinCo Foods LLC46b58c71-d62e-4b3d-b2ec-65407032eeea2024-11-21WarningsExact identifier
ndc (package): 67091-051-28
ndc (product): 67091-051
ndc11 (package): 67091005128
spl id: f27bd705-6df0-4fcd-bc25-0324897f1226
spl set id: 46b58c71-d62e-4b3d-b2ec-65407032eeea

Reported adverse events (FAERS/openFDA)#

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