FDA.reportPublic FDA data

Foot Works Healthy

Manufacturer
New Avon LLC
Effective date
2019-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:59:20

Label at a glance#

ProductFoot Works Healthy Antifungal
Active ingredientTOLNAFTATE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Tolnaftate 1.0%.........................

OTC - PURPOSE SECTION

         Purpose
.......................Antifungal

INDICATIONS & USAGE SECTION

Uses
• proven clinically effective in the treatment of most athlete’s foot (tinea pedis)
• relieves itching, burning feet
• prevents the recurrence of most athlete’s foot (tinea pedis) with daily use

WARNINGS SECTION

Warnings
For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product
• avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if
• irritation occurs or if 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.

DOSAGE & ADMINISTRATION SECTION

Directions
• To treat athlete’s foot, clean the affected area with soap and water and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Use daily for 4 weeks. If condition persists longer, consult a doctor. Not effective for infections of the nails or scalp.

• To prevent athlete’s foot, clean the feet and dry thoroughly. Apply a thin layer of the product to the feet once or twice daily (morning and/or night).
• Supervise children in the use of this product.
• Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, cotton socks, and change shoes and socks at least once daily.

INACTIVE INGREDIENT SECTION

Inactive ingredients
TALC, ZINC OXIDE, SODIUM SILICOALUMINATE, TRICALCIUM PHOSPHATE, METHYLPARABEN, SODIUM POLYACRYLATE, WATER/EAU.

OTC - QUESTIONS SECTION

QUESTIONS? Call 1-800-FOR-AVON or 1-800-265-AVON in Canada

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

IMAGE OF LABELIMAGE OF LABELIMAGE OF DFBIMAGE OF DFBIMAGE OF DFBIMAGE OF DFB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313422tolnaftate 1 % Topical PowderPSN4
313422tolnaftate 0.01 MG/MG Topical PowderSCD4
313422tolnaftate 1 % Topical PowderSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0303-12021-01-29C16284748780-1ba0f9c33-3b79-a910-e053-dadaa90a0b85Footworks Antifungal Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0303-1Foot Works HealthyAntifungal74 g in 1 CANISTERPOWDER744

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0303FOOT WORKS HEALTHY ANTIFUNGAL (TOLNAFTATE) POWDER [NEW AVON LLC]4Legacy NDC, 1 package rows20190426_c4c37460-0e0e-4fcf-97db-0ae0b881cf5a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKV1
TOLNAFTATEACTIVE MOIETY06KB629TKV1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10096-030310096-0303-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOLNAFTATE06KB629TKVACTIB
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
8761fd5e-f2ca-5101-e053-2995a90ac621c4c37460-0e0e-4fcf-97db-0ae0b881cf5a2019-01-01WarningsExact identifier
spl id: 8761fd5e-f2ca-5101-e053-2995a90ac621
spl set id: c4c37460-0e0e-4fcf-97db-0ae0b881cf5a

Reported adverse events (FAERS/openFDA)#

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