FDA.reportPublic FDA data

Toenail Fungus Pen Preventative - Guangzhou Mizi Biotechnology Co., Ltd.

Manufacturer
Guangzhou Mizi Biotechnology Co., Ltd.
Effective date
2026-05-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:58:50

Label at a glance#

ProductToenail Fungus Pen Preventative
Active ingredientMICONAZOLE NITRATE, UNDECYLENIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

AQUA 54.31%
aluminum chloride 0.1%
Berberis Root Extract 0.05%
Dipotassium Glycyrrhizinate 0.05%
Glycyrrhiza Glabra (Licorice) Root Extract 0.05%
Allantoin 2%
menthol 1%
Propylene glycol 5%
Butylene Glycol 5%
Glycerol polyether-26 0.05%
Sodium Hyaluronate 0.05%
ethanol 5%
Methyl glucosinol polyether-20 0.05%
sodium hydroxide 0.02%
Sorbic AcidPotassium Salt 0.2%
Sodium Pyrosulfite 0.02%

DOSAGE & ADMINISTRATION SECTION

Shake can well and spray a thin layer of the product to the feet once or twice daily(morning and/or night)

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - ACTIVE INGREDIENT SECTION

Undecylenic Acid 25%
Miconazole nitrate 2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed,get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Inhibit fungi Eliminates Foot Odor

INDICATIONS & USAGE SECTION

Helps prevent most athlete's foot fungus with daily use.Treats nail fungus and skin' fungal infections.

Shake can well and spray a thin layer of the product to the feet once or twice daily(morning and/or night)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label imageLabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2743718miconazole nitrate 2 % / undecylenic acid 25 % Topical SprayPSN1
2743718miconazole nitrate 20 MG/ML / undecylenic acid 250 MG/ML Topical SpraySCD1
2743718miconazole nitrate 2 % / undecylenic acid 25 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84896-010-01Toenail Fungus Pen Preventative60 mL in 1 BOTTLESPRAY601

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84896-01084896-010-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
AQUA059QF0KO0RIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
UNDECYLENIC ACIDK3D86KJ24NACTIB

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
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
ndc (package): 84896-010-01
ndc (product): 84896-010
ndc11 (package): 84896001001
spl id: 52b6766f-948c-2602-e063-6294a90a03cf
spl set id: 52b6766f-948b-2602-e063-6294a90a03cf

Reported adverse events (FAERS/openFDA)#

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