Antifungal Powder Spray

Manufacturer
Dong Yuan Technology Co., Ltd.
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:06

Label at a glance#

ProductANTIFUNGAL For Athletes Foot
Active ingredientTOLNAFTATE
Label structure12 sections

Indications and 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

Dosage and administration

■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ 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 a day ■ use daily for 4 weeks, if conditions persist longer, ask a doctor ■ to prevent at...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

■ 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

WARNINGS SECTION

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

■ avoid contact with eyes ■ use only as directed. Intentional misuse by deliberetely concentrating and inhaling contents can be harmful or fatal ■ contents under pressure. Do not puncture or incinerate.

Do not stire at a temperature above 120ºF (49ºC​)

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

■ irritation occurs ■ there is no improvement within 4 weeks

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

■ wash affected area and dry thoroughly ■ shake can well and spray a thin layer over affected area twice daily (morning and night) ■ 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 a day ■ use daily for 4 weeks, if conditions persist longer, ask 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 ■ in case of clogging, clean nozzle with pin

Other information

SPL UNCLASSIFIED SECTION

■ store between 68º to 77ºF (20º to 25ºC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

alcohol denat., butane, fragrance, propane, triethanolamine, zea mays (corn) starch

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
705934tolnaftate 1 % Powder SprayPSN2
705934tolnaftate 0.01 MG/MG Powder SpraySCD2
705934tolnaftate 1 % Powder SpraySY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72109-001-572024-01-30C16284748780-11030e365-238c-111a-e063-dadaa90a10e2Antifungal Powder Spray
72109-001-852024-01-30C16284748780-11030e365-238c-111a-e063-dadaa90a10e2Antifungal Powder Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72109-001-57ANTIFUNGALFor Athletes Foot57 g in 1 CANPOWDER572
72109-001-85ANTIFUNGALFor Athletes Foot85 g in 1 CANPOWDER852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72109-001ANTIFUNGAL FOR ATHLETES FOOT (TOLNAFTATE) POWDER [DONG YUAN TECHNOLOGY CO., LTD.]2Legacy NDC, 2 package rows20220118_9f69adbe-45c1-2bad-e053-2995a90a1cea.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72109-00172109-001-85, 72109-001-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
d5cb63bf-ec72-299d-e053-2a95a90ab8869f69adbe-45c1-2bad-e053-2995a90a1cea2022-01-17WarningsExact identifier
spl id: d5cb63bf-ec72-299d-e053-2a95a90ab886
spl set id: 9f69adbe-45c1-2bad-e053-2995a90a1cea

Reported adverse events (FAERS/openFDA)#

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