FDA.reportPublic FDA data

Premier Solutions Foot Odor Control Powder Spray

Manufacturer
Premier Brands of America Inc.
Effective date
2025-12-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:25:46

Label at a glance#

ProductFoot Odor Control Powder
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents recurrence of athlete's foot with daily use relieves 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) 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 use daily for 4 weeks if conditions persists, consult a doctor ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures mose athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • prevents recurrence of athlete's foot with daily use
  • relieves itching, burning and cracking

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store above 120°F. Intentional misuse by deliberately concentrating and inhaling the contents cans 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

  • irritation occurs
  • 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

  • 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
  • use daily for 4 weeks
  • if conditions persists, consult 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
  • if nozzle clogs, clear nozzle under running warm water until unclogged

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

disteardimonium hectorite, fragrance, isobutane, isopropyl myristate, SD alcohol 40-B, sodium bicarbonate

Questions?

OTC - QUESTIONS SECTION

Call 888-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FOOT ODOR

CONTROL

ANTIFUNGAL Spray

TOLNAFTATE 1%

​


CURES & PREVENTS
MOST ATHLETE'S FOOT

  • Relieves itching, burning & cracking
  • Talc-free
  • Reduces foot odor

NET WT. 4 OZ (113g)

image 1image 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-252-01Foot Odor Control Powder113 g in 1 CANAEROSOL, SPRAY1136

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
56104-25256104-252-01

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
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISOBUTANEBXR49TP611IACT
ALCOHOL3K9958V90MIACT
SODIUM BICARBONATE8MDF5V39QOIACT
TOLNAFTATE06KB629TKVACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52025-11-03monthly-update2026-06-03 17:39:50
42024-10-14full-release2026-06-01 00:25:26

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
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
ndc (package): 56104-252-01
ndc (product): 56104-252
ndc11 (package): 56104025201
spl id: 45c7c11b-d629-aee8-e063-6294a90a401d
spl set id: edb0a2da-aaa1-3b9b-e053-2995a90a5012

Reported adverse events (FAERS/openFDA)#

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