FDA.reportPublic FDA data

Footworks Antifungal Spray

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

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
SD ALCOHOL 40-B, PEG-12, PEG-6, PROPYLENE CARBONATE, PARFUM/FRAGRANCE, BHT.

OTC - QUESTIONS SECTION

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

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.

STORAGE AND HANDLING SECTION

Flammable. Keep from fire or heat.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of PDPimage of PDPimage of DFBimage of DFB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313421tolnaftate 1 % Topical SprayPSN4
313421tolnaftate 10 MG/ML Topical SpraySCD4
313421tolnaftate 1 % Topical SpraySY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10096-0272-12021-01-29C16284748780-1ba0f9c33-3b5e-a910-e053-dadaa90a0b85Footworks Antifungal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10096-0272-1Foot Works HealthyAntifungal100 mL in 1 BOTTLE, SPRAYSPRAY1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10096-0272FOOT WORKS HEALTHY ANTIFUNGAL (TOLNAFTATE) SPRAY [NEW AVON LLC]4Legacy NDC, 1 package rows20190426_7357adcd-437d-4651-8922-6ef830f9f85a.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
10096-027210096-0272-1

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
WATER059QF0KO0RIACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML · Source PDF

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
8761dd8e-3a28-c84d-e053-2995a90ac02e7357adcd-437d-4651-8922-6ef830f9f85a2019-01-01WarningsExact identifier
spl id: 8761dd8e-3a28-c84d-e053-2995a90ac02e
spl set id: 7357adcd-437d-4651-8922-6ef830f9f85a

Reported adverse events (FAERS/openFDA)#

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