FDA.reportPublic FDA data

Premier Solutions Tolnaftate Powder Spray - Talc Free

Manufacturer
Premier Brands of America Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:52:38

Label at a glance#

ProductPremier Solutions Antifungal Tolnaftate Powder
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

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

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) 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 condit...

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 athelete's foot (tinea pedis) and ringworm (tinea corporis)
  • prevents the recurrence of most athelete's foot with daily use
  • for effective relief of itching, cracking and burning

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Contents under pressure. Avoid Spraying eyes. do not use or store near heat or open flame. Do not puncture or incinerate. Do not store at temperature above 120ºF. Keep out of reach of children. Use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • if irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm

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

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer 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 conditions persist, consult a doctor
  • to prevent athlete's foot: wash the feet and dry throughly; spray a thing layer of the product to the feet once or twice daily (morning and/or night)
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

Other information

OTHER SAFETY INFORMATION

store between 20º and 30ºC (68ºF and 86º)

Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, Isobutane, Kaolin, PPG-12-Buteth-16, SD Alcohol 40-B, Zea Mays (Corn) Starch

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Meijer

Antifungal

Athlete's Foot

Powder Spray

Tolnaftate 1%

  • Cures most athlete's foot
  • Relieves itching & burning
  • Talc free

NET WT 4.6 OZ (130g)

image 1image 1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-248PREMIER SOLUTIONS ANTIFUNGAL TOLNAFTATE POWDER (TOLNAFTATE POWDER SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]4Legacy NDC20241016_e2228302-3596-0526-e053-2a95a90a8882.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-24856104-248-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
KAOLIN24H4NWX5COIACT
PPG-12-BUTETH-1658CG7042J1IACT
ALCOHOL3K9958V90MIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
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
3bba6160-f1e6-e6be-e063-6294a90ab85ce2228302-3596-0526-e053-2a95a90a88822025-08-06WarningsExact identifier
spl set id: e2228302-3596-0526-e053-2a95a90a8882

Reported adverse events (FAERS/openFDA)#

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