FDA.reportPublic FDA data

BLDAXN FUNGUS NAIL PEN

Manufacturer
Guangdong Quadrant Ecological Technology Co., Ltd.
Effective date
2026-02-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:19

Label at a glance#

ProductBLDAXN FUNGUS NAIL PEN
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

UNDECYLENIC ACID 25%
TOLNAFTATE 1%

OTC - PURPOSE SECTION

Renew Nails

INDICATIONS & USAGE SECTION

Treats fungal infections of fingernails, toenails, and surrounding skin.Effective against athlete's foot, ringworm, and nail fungus. Helps improve nail discoloration, thickness, and cracking.

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

If you experience any signs of sensitivity or irritation, discontinue use and consult a doctor.

OTC - WHEN USING SECTION

When using this product Avoid contact with eyes.

OTC - STOP USE SECTION

Stop use and ask a doctor If discomfort persists.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If the product gets into your eyes, flush with water for 15 minutes.
Ifswallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

1. Clean and dry the affected nail and surrounding area.

2. Twist the base of the pen clockwise until the brush tip is saturated

3. Apply a thin layer to the entire nail. Allow it to dry for 2-3 minutes.

4. Apply twice daily (morning and night) until a healthy nail has fully grown out.

INACTIVE INGREDIENT SECTION

ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76986-026-01BLDAXN FUNGUS NAIL PEN2.5 mL in 1 BOTTLELIQUID2.51
76986-026-01BLDAXN FUNGUS NAIL PEN4 in 1 BOXLIQUID41

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76986-02676986-026-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZIACT
HYDROXYPROPYLCELLULOSE9XZ8H6N6OHIACT
MENTHOLL7T10EIP3AIACT
TOLNAFTATE06KB629TKVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
UREA8W8T17847WIACT
ZANTHOXYLUM BUNGEANUM FRUIT3CIP16A418IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
EDETATE DISODIUM7FLD91C86KIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB
GLYCOLIC ACID0WT12SX38SIACT

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
BLDAXN FUNGUS NAIL PENUNDECYLENIC ACID, TOLNAFTATEGuangdong Quadrant Ecological Technology Co., Ltd.49e291e1-be83-8926-e063-6394a90a13c22026-02-02WarningsExact identifier
ndc (package): 76986-026-01
ndc (product): 76986-026
ndc11 (package): 76986002601
spl id: 49e291e1-be84-8926-e063-6394a90a13c2
spl set id: 49e291e1-be83-8926-e063-6394a90a13c2

Reported adverse events (FAERS/openFDA)#

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