Winco Antifungal Tolnaftate 1% Cream 1 oz 24193 ZDP (2021)

Manufacturer
Winco Foods, LLC
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:07

Label at a glance#

ProductWinco Antifungal
Active ingredientTOLNAFTATE
Label structure13 sections

Storage and handling

Other information store at room temperature 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Tolnaftate 1%....................................Antifungal

OTC - PURPOSE SECTION

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product, avoid contact with the eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • 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 (1-800-222-1222) right away.

INDICATIONS & USAGE SECTION

Directions

  • wash affected area and dry thoroughly
  • apply a thin layer of the product 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 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

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredient cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Winco Foods, LLC

Boise, ID 83704

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2419324193

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
67091-190-282025-01-30C16284748780-12cef2736-7d10-d83d-e063-dadaa90ab31fWinco Antifungal Tolnaftate 1% Cream 1 oz 24193 ZDP (2021)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-190-28Winco Antifungal1 in 1 CARTONCREAM12
67091-190-28Winco Antifungal28 g in 1 TUBECREAM282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-190WINCO ANTIFUNGAL (TOLNAFTATE) CREAM [WINCO FOODS, LLC]2Legacy NDC, 2 package rows20220118_b8bc3272-6d3e-59b8-e053-2995a90a2fd7.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67091-19067091-190-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

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
d5cd6565-27fe-4836-e053-2995a90a785fb8bc3272-6d3e-59b8-e053-2995a90a2fd72022-01-17WarningsExact identifier
spl id: d5cd6565-27fe-4836-e053-2995a90a785f
spl set id: b8bc3272-6d3e-59b8-e053-2995a90a2fd7

Reported adverse events (FAERS/openFDA)#

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