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ERWCNMIE Toenail Fungus Treatment Pen

83766-108 ERWCNMIE Toenail Fungus Treatment Pen

Approved
Approval ID

3dce0c33-d4f3-5135-e063-6394a90a85a6

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

Shenzhen Joyuflsh Technology Co.,Ltd.

DUNS: 603012375

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Tolnaftate, UNDECYLENIC ACID

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code83766-108
Application Number505G(a)(3)
Product Classification
M
Marketing Category
C200263
G
Generic Name
Tolnaftate, UNDECYLENIC ACID
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (14)

ETHYLHEXYLGLYCERINInactive
Code: 147D247K3P
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
LAUROCAPRAMInactive
Code: 1F3X9DRV9X
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
C12-15 ALKYL LACTATEInactive
Code: GC844VRD7E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TOLNAFTATEActive
Quantity: 1 g in 100 mL
Code: 06KB629TKV
Classification: ACTIB
UNDECYLENIC ACIDActive
Quantity: 25 g in 100 mL
Code: K3D86KJ24N
Classification: ACTIB
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
SOPHORA FLAVESCENS ROOTInactive
Code: IYR6K8KQ5K
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

Tolnaftate 1%
UNDECYLENIC ACID 25%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Anti-fungal and Nail Renewal

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/2/2025

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 9/2/2025

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

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/2/2025

lrritation occurs or discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/2/2025

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/2/2025

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

LOINC: 51727-6Updated: 9/2/2025

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

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ERWCNMIE Toenail Fungus Treatment Pen - FDA Drug Approval Details