FDA.reportPublic FDA data

Premier Solutions Antifungal Spray Liquid

Manufacturer
Premier Brands of America, Inc.
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:42:09

Label at a glance#

ProductPremier Solutions Antifungal Tolnaftate Liquid
Active ingredientTOLNAFTATE
Label structure9 sections

Indications and uses

proven clinically effective in the treatment of athlete's foot (tinea pedis) and ringworm (tinea corporis) prevents the recurrence of most athlete'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 condi...

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 athlete's foot (tinea pedis) and ringworm (tinea corporis)
  • prevents the recurrence of most athlete'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 in 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

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

​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 condition persists, consult a doctor
  • to prevent athlete's foot, wash the feet and dry thoroughly; spray a thin 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, clear with a pin

​Other information

OTHER SAFETY INFORMATION

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

​Inactive ingredients

INACTIVE INGREDIENT SECTION

BHT, isobutane, PPG-12-buteth-16, SD alcohol 40-B

​ ​Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

​Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​Premier Solutions​

Antifungal

Athlete's Foot

Liquid Spray

Tolnaftate 1%

Cures most athlete's foot and prevents recurrences

Relieves itching, cracking and burning

Net WT 5.3 OZ (150g)

Image 1Image 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-247-01Premier Solutions Antifungal Tolnaftate Liquid150 g in 1 CANAEROSOL, SPRAY1505

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-24756104-247-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ISOBUTANEBXR49TP611IACT
PPG-12-BUTETH-1658CG7042J1IACT
TOLNAFTATE06KB629TKVACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
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
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
ndc (package): 56104-247-01
ndc (product): 56104-247
ndc11 (package): 56104024701
spl id: 42b87b97-8d46-64ec-e063-6294a90a6b87
spl set id: e1971c1c-5687-577b-e053-2a95a90ad95f

Reported adverse events (FAERS/openFDA)#

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