FungiFree Nail Fungus Treatment

Manufacturer
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Effective date
2024-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:41

Label at a glance#

ProductFungiFree Nail Fungus Treatment
Active ingredientKETOCONAZOLE, TOLNAFTATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Fact LabelDrug Fact Label

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Ketoconazole 1.7%...................................................................................................................Anti-fungal

Tolnaftate 1.0%.........................................................................................................................Anti-fungal

OTC - PURPOSE SECTION

Treatment of fingernail and toenail fungus

INDICATIONS & USAGE SECTION

Uses

DOSAGE & ADMINISTRATION SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with eyes.

OTC - ASK DOCTOR SECTION

Stop and ask a doctor if - irritation occurs - there is no improvement within 6 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

INSTRUCTIONS FOR USE SECTION

Directions

-Soak your nails in warm water for 5 minutes, then dry them.

-Cut and trim affected nails.

-Dip the brush (attached on cap) into the treatment solution.

-Apply the solution over the affected parts, including the root(s) of the nail(s).

-Use 2 times a day, in the morning and before sleep.

INACTIVE INGREDIENT SECTION

Inactive ingredients Aqua, Sorbitol, Ethanol, Propylene Glycol, Salicylic Acid, Deacetylated Chitin, Angelica Dahurica, Lactic Acid, Chlorhexidine Acetate, Laurocapram

OTHER SAFETY INFORMATION

Other information store at 10-35°C (50.0-95.0°F)

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
KETOCONAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd9dd88b-5db8-6370-b47e-37f6c9b1c5d5Product name220250331
1e18fb2e-aeff-8efe-93be-5a5f7be8faa2Product name220211209
8bc3781f-20ed-678b-44a7-a981e693c65fProduct name220211209
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ff3a8c91-648c-300b-467e-10703f514265Product name220180809
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
152a96a4-36b6-f5b1-d4e6-9a500e06bbf3Product name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83364-005-01FungiFree Nail Fungus Treatment1 in 1 BOXSOLUTION11
83364-005-02FungiFree Nail Fungus Treatment30 g in 1 BOTTLESOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83364-005FUNGIFREE NAIL FUNGUS TREATMENT (KETOCONAZOLE, TOLNAFTATE) SOLUTION [YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD]12 package rows20240518_186e7e21-b3f5-1c94-e063-6394a90adaeb.zip

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
83364-00583364-005-02, 83364-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
186e7e21-b3f6-1c94-e063-6394a90adaeb186e7e21-b3f5-1c94-e063-6394a90adaeb2024-05-14WarningsExact identifier
spl id: 186e7e21-b3f6-1c94-e063-6394a90adaeb
spl set id: 186e7e21-b3f5-1c94-e063-6394a90adaeb

Reported adverse events (FAERS/openFDA)#

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