FDA.reportPublic FDA data

Toe Fungus

Manufacturer
Imperial Feet B.V.
Effective date
2025-10-17
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:39:45

Label at a glance#

ProductToe Fungus
Active ingredientTOLNAFTATE
Label structure11 sections

Dosage and administration

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected are twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. If condition persists longer, consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate

Ask a doctor

OTC - ASK DOCTOR SECTION

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor

Purpose

OTC - PURPOSE SECTION

Antifungal

Use

INDICATIONS & USAGE SECTION

Cures most fungus on toes

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Supervise children in the use of this product.

Stop Use Section

OTC - STOP USE SECTION

If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash the affected area and dry thoroughly.
  • Apply a thin layer of the product over affected are twice daily (morning and night) or as directed by a doctor.
  • Supervise children in the use of this product.
  • Pay special attention to spaces between toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
  • If condition persists longer, consult a doctor.

Warnings

WARNINGS SECTION

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with the eyes.
  • If irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a doctor.

Other Information

OTHER SAFETY INFORMATION

Store between 20 C and 30 C (68 F and 86 F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alpha-Bisabolene, Chlorphenesin, Glycerin, Horse Chestnut, Jojoba Oil, Methyl Gluceth-20, Phenoxyethanol, Piroctone Olamine, Polyethylene Glycol 400, Polyoxyl 40 Hydrogenated Castor Oil, Squalene, Tea Tree Oil, Water

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Version 3Version 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN5
313423tolnaftate 10 MG/ML Topical SolutionSCD5
313423tolnaftate 1 % Topical SolutionSY5

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138720254597973GTIN-13: 8720254597973
EAN-13: 8720254597973
GTIN storage (14 digits): 08720254597973		Imperial Feet 32217 032.jpg
QR code linkQR Codeimperialfeet.com/products/nail-mycosis-solutionImperial Feet 32217 032.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83837-001-01Toe Fungus75 mL in 1 BOTTLE, DROPPERSOLUTION755

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83837-00183837-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALENE7QWM220FJHIACT
WATER059QF0KO0RIACT
TOLNAFTATE06KB629TKVACTIB
.ALPHA.-BISABOLENESUQ209P6FXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYL GLUCETH-20J3QD0LD11PIACT
JOJOBA OIL724GKU717MIACT
HORSE CHESTNUT3C18L6RJAZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PIROCTONE OLAMINEA4V5C6R9FBIACT
CHLORPHENESINI670DAL4SZIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-03-26full-release2026-06-01 00:57:44

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
Toe FungusTOLNAFTATEImperial Feet B.V.118a6c97-4e8a-050a-e063-6294a90a11082025-10-17WarningsExact identifier
ndc (package): 83837-001-01
ndc (product): 83837-001
ndc11 (package): 83837000101
spl id: 4162e05b-0726-b310-e063-6294a90a0fa0
spl set id: 118a6c97-4e8a-050a-e063-6294a90a1108

Reported adverse events (FAERS/openFDA)#

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