FDA.reportPublic FDA data

LUXURY Athlete's Foot Powder Spray

Manufacturer
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2021-03-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:55

Label at a glance#

ProductLuxury
Active ingredientTOLNAFTATE
Label structure8 sections

Indications and uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis) helps prevents most athlete's foot with daily use for effective relief of itching, cracking and burning

Dosage and administration

shake can well and spray a thin layer over affected area twice daily (morning and night) wash affected area and dry thoroughly hold can 4-6 inches away from affected area 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 use daily for 4 weeks; if condition persists l...

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 prevents most athlete's foot with daily use
  • for effective relief of itching, cracking and burning

Warnings

WARNINGS SECTION

For external use only.

Extremely flammable:

SAFE HANDLING WARNING SECTION

Do not use while smoking or near heat or flame 

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes 
  • use only as directed. intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
  • contents under pressure. Do not puncture or incinerate. Do not store temperature above 120 F (49 C)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • There is no improvement within 4 weeks

Do not use

OTC - DO NOT USE SECTION

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

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

  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • wash affected area and dry thoroughly
  • hold can 4-6 inches away from affected area
  • 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
  • use daily for 4 weeks; if condition persists longer, ask a doctor
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
  • in case of  clogging , clean nozzle with a pin

Other information

OTHER SAFETY INFORMATION

  • store between 20° and 25°C (68° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol denat, Butane , Isobutene , Triethanolamine , zea mays (corn) starch.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76772-022-572023-01-30C16284748780-1f386c649-ecc9-0266-e053-dadaa90a7c1aLUXURY Athlete's Foot Powder Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-022-57Luxury57 g in 1 CANISTERAEROSOL, SPRAY572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-022LUXURY (ATHLETE FOOT POWDER) AEROSOL, SPRAY [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20210312_61ded99e-970e-4c61-8b61-1cac61e309da.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-02276772-022-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTANE6LV4FOR43RIACT
ISOBUTYLENEQA2LMR467HIACT
TROLAMINE9O3K93S3TKIACT
STARCH, CORNO8232NY3SJIACT
ALCOHOL3K9958V90MIACT
TOLNAFTATE06KB629TKVACTIB

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
bd3aecf5-3806-53d6-e053-2a95a90a83db61ded99e-970e-4c61-8b61-1cac61e309da2021-03-10WarningsExact identifier
spl id: bd3aecf5-3806-53d6-e053-2a95a90a83db
spl set id: 61ded99e-970e-4c61-8b61-1cac61e309da

Reported adverse events (FAERS/openFDA)#

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