FDA.reportPublic FDA data

ERWCNMIE Toenail Fungus Treatment Pen

Manufacturer
Shenzhen Joyuflsh Technology Co.,Ltd.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:22

Label at a glance#

ProductERWCNMIE Toenail Fungus Treatment Pen
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

Anti-fungal and Nail Renewal

INDICATIONS & USAGE SECTION

For the effective treatment of nail fungus-including discoloration,.
thickening, splitting, crumbling, and brittleness.

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.

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

lrritation occurs or discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidental ingestion occurs, seek medical attention immediatelyand contact a Poison Control Center.

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 thebrush.
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 beingtreated.

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionPSN1
2691548tolnaftate 10 MG/ML / undecylenic acid 250 MG/ML Topical SolutionSCD1
2691548tolnaftate 1 % / undecylenic acid 25 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83766-108-01ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-01ERWCNMIE Toenail Fungus Treatment Pen3 in 1 PACKAGELIQUID31
83766-108-02ERWCNMIE Toenail Fungus Treatment Pen6 in 1 PACKAGELIQUID61
83766-108-02ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-03ERWCNMIE Toenail Fungus Treatment Pen5 mL in 1 BOTTLE, WITH APPLICATORLIQUID51
83766-108-03ERWCNMIE Toenail Fungus Treatment Pen9 in 1 PACKAGELIQUID91

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83766-10883766-108-01, 83766-108-02, 83766-108-03

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
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LAUROCAPRAM1F3X9DRV9XIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
C12-15 ALKYL LACTATEGC844VRD7EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
TOCOPHEROLR0ZB2556P8IACT
WATER059QF0KO0RIACT
TOLNAFTATE06KB629TKVACTIB
UNDECYLENIC ACIDK3D86KJ24NACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ALCOHOL3K9958V90MIACT

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
ERWCNMIE Toenail Fungus Treatment PenTOLNAFTATE, UNDECYLENIC ACIDShenzhen Joyuflsh Technology Co.,Ltd.3dce0c33-d4f3-5135-e063-6394a90a85a62025-09-02WarningsExact identifier
ndc (package): 83766-108-01
ndc (package): 83766-108-02
ndc (package): 83766-108-03
ndc (product): 83766-108
ndc11 (package): 83766010802
ndc11 (package): 83766010803
ndc11 (package): 83766010801
spl id: 3dce0c33-d4f4-5135-e063-6394a90a85a6
spl set id: 3dce0c33-d4f3-5135-e063-6394a90a85a6

Reported adverse events (FAERS/openFDA)#

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