EZBIORT Toenail Fungus Treatment Pen

Manufacturer
Shenzhen Joyuflsh Technology Co.,Ltd.
Effective date
2025-09-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:12:39

Key Label Information#

Active Ingredients And Purpose

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal and Nail Renewal

Uses

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus-including discoloration, thickening, spliting, crumbling, and britleness

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Children under 2 years of age. Pregnant or if there is any allergic reaction to this produce.

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

1.Wash and dry your nails thoroughly before applying the product. Remove the cap that covers the brush. 2.Twist the end of the pen clockwise to dispense the liquid onto the brush. 3.Apply the liquid three times to the areas requiring treatment, ensuring complete coverage of all affected parts. 4.Use 2 times daily for 2-4 weeks, depending on the condition being treated.

Other Label Information

INACTIVE INGREDIENT SECTION

ALCOHOL POLYETHYLENE GLYCOL PROPYLENE GLYCOL DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN GLYCERIN LAUROCAPRAM SOPHORA FLAVESCENS ROOT TOCOPHEROL PHENOXYETHANOL WATER

Label Images#

label
label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN3
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD3
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83766-107-01DRAWZONE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID53
83766-107-01DRAWZONE Toenail Fungus Treatment Pen6 in 1 PACKAGELIQUID63

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83766-10783766-107-01

Ingredients#

Complete SPL Sections#

OTC - ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1% UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

Anti-fungal and Nail Renewal

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus-including discoloration, thickening, spliting, crumbling, and britleness

WARNINGS SECTION

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

OTC - DO NOT USE SECTION

Children under 2 years of age. Pregnant or if there is any allergic reaction to this produce.

OTC - WHEN USING SECTION

OTC - WHEN USING SECTION

Avoid contact with eyes. lf in eyes, rinse thoroughly with water.

OTC - STOP USE SECTION

OTC - STOP USE SECTION

lrritation occurs or discomfort persists

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf accidental ingestion occurs, seek medical attention immediately and contact a Poison Control Center.

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

1.Wash and dry your nails thoroughly before applying the product. Remove the cap that covers the brush. 2.Twist the end of the pen clockwise to dispense the liquid onto the brush. 3.Apply the liquid three times to the areas requiring treatment, ensuring complete coverage of all affected parts. 4.Use 2 times daily for 2-4 weeks, depending on the condition being treated.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENT SECTION

ALCOHOL POLYETHYLENE GLYCOL PROPYLENE GLYCOL DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN GLYCERIN LAUROCAPRAM SOPHORA FLAVESCENS ROOT TOCOPHEROL PHENOXYETHANOL WATER

Source Document#

Source XML