FDA.reportPublic FDA data

FungiFree Fungal Nail Patches

Manufacturer
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:22

Label at a glance#

ProductFungiFree Fungal Nail Patches
Active ingredientTOLNAFTATE
Label structure4 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions

- Remove any nail polish before use. Clean and thoroughly dry the affected area. - Peel off the protective film from the patch, starting with the outer edge and then the inner side. - Center the white area of the patch over the infected part of the nail. - Apply the adhesive side directly onto the nail. - Wrap the sides of the patch around the toe or finger to ensure a snug fit. - Fold the remaining adhesive part over the toe or fingertip. - Leave the patch on for 6-8 hours. For best results, use overnight for 3-6 months

OTHER SAFETY INFORMATION

Other information Store at room temperature 15°-30°C (59°-86°F), away from excess heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients Glycerin, Tartaric Acid, Polysorbate 80, 1.2-Hexanediol, Disodium EDTA, Cellulose Gum, Sodium Polyacrylate, Aluminum Glycinate, Fumaric Acid, Butylene Glycol, Urea, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts drug factsdrug facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Tolnaftate 1.0%

OTC - PURPOSE SECTION

Anti-fungal

INDICATIONS & USAGE SECTION

Repairs fungal nail damage and improves nail appearance

OTC - DO NOT USE SECTION

Do not use on children under 3 years of age unless directed by a doctor.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. In case of contact, rinse thoroughly with water

OTC - ASK DOCTOR SECTION

Stop and ask a doctor if - irritation occurs - there is no improvement within 4 weeks

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away

WARNINGS SECTION

Warnings

For external use only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2677690tolnaftate 1 % Medicated PatchPSN2
2677690tolnaftate 0.01 MG/MG Medicated PatchSCD2
2677690tolnaftate 1 % Medicated PatchSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83364-013-01FungiFree Fungal Nail Patches0.7 g in 1 PATCHPATCH0.72
83364-013-01FungiFree Fungal Nail Patches21 in 1 PATCHPATCH212

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83364-01383364-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
1,2-HEXANEDIOLTR046Y3K1GIACT
ALUMINUM GLYCINATE1K713C615KIACT
CELLULOSE GUMK679OBS311IACT
TOLNAFTATE06KB629TKVACTIB
TARTARIC ACIDW4888I119HIACT
EDETATE DISODIUM7FLD91C86KIACT
UREA8W8T17847WIACT
GLYCERINPDC6A3C0OXIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WATER059QF0KO0RIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
FUMARIC ACID88XHZ13131IACT

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
FungiFree Fungal Nail PatchesTOLNAFTATEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD26e4397e-a158-d468-e063-6394a90ac7652026-01-28WarningsExact identifier
ndc (package): 83364-013-01
ndc (product): 83364-013
ndc11 (package): 83364001301
spl id: 497a57ae-c7c5-278b-e063-6294a90adcd2
spl set id: 26e4397e-a158-d468-e063-6394a90ac765

Reported adverse events (FAERS/openFDA)#

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