FDA.reportPublic FDA data

ONIADBA Nail Fungus Treatment Pen

Manufacturer
Shenzhen Boyimei Technology Co., Ltd.
Effective date
2025-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:09:27

Label at a glance#

ProductONIADBA Nail 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

INDICATIONS & USAGE SECTION

Antifungal treatment for fingernails, toenails, and surrounding skin.Effective against fungal nails.athlete's foot, tinea manuum, and ringworm caused by fungi.Addresses nail fungus,discoloration, thickening, splitting, and crumbling

WARNINGS SECTION


Keep away from fire and flames.
Keep out of reach of children.
For external use on nails and the immediately adjacent skin only.

OTC - DO NOT USE SECTION

Do not use if you experience any signsof sensitivity or irritation.

OTC - WHEN USING SECTION

Not for use in the eyes, mouth, or vaginal area

OTC - STOP USE SECTION


If the area of application shows increased irritation
If there is no improvement within 8 weeks.
If pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


If accidental ingestion occurs, seek medical
assistance or contact a Poison Control
Center immediately.

DOSAGE & ADMINISTRATION SECTION

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Alcohol, Propylene Glycol,Angelica Dahurica,Chlorhexidine Diacetate Hydrate, Laurocapram, Caramel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label4label4

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
85992-004-01ONIADBA Nail Fungus Treatment Pen5 mL in 1 TUBE, WITH APPLICATORLIQUID51
85992-004-01ONIADBA Nail Fungus Treatment Pen4 in 1 BOXLIQUID41

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85992-00485992-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAUROCAPRAM1F3X9DRV9XIACT
TOLNAFTATE06KB629TKVACTIB
CHLORHEXIDINE DIACETATE5908ZUF22YIACT
ALCOHOL3K9958V90MIACT
CARAMELT9D99G2B1RIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ANGELICA DAHURICA ROOT1V63N2S972IACT

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
ONIADBA Nail Fungus Treatment PenTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3bad19f1-d5b3-c5de-e063-6294a90a0c032025-08-06WarningsExact identifier
ndc (package): 85992-004-01
ndc (product): 85992-004
ndc11 (package): 85992000401
spl id: 3bad19f1-d5b4-c5de-e063-6294a90a0c03
spl set id: 3bad19f1-d5b3-c5de-e063-6294a90a0c03

Reported adverse events (FAERS/openFDA)#

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