FDA.reportPublic FDA data

85304-032 EZBIORT 1% Tolnaftate Nail Essence with Biotin

Manufacturer
Guangzhou Borderless Technology Co., Ltd.
Effective date
2026-07-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-17 21:45:34

Label at a glance#

ProductEZBIORT 1% Tolnaftate Nail Essence with Biotin
Active ingredientTOLNAFTATE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Antifungal treatment for fingernails,toenails, and surrounding skin.Effective against fungal nails and athlete's foot caused by fungi

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use if you experience any signs of sensitivity or irritation

OTC - WHEN USING SECTION

While using this product: Not for use in the eyes, mouth, or vaginal area.

OTC - STOP USE SECTION

Stop use and consult a doctor if: If the area of application shows increased irritation If there is Consult a doctor if symptoms worsen. 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


For athlete's foot and ringworm: use daily for 4 weeks.Clean the affected area and dry thoroughly.
For external use on nails and the immediately adjacent skin only. Twice a day lonce in the morning and once in the evening), apply or spray the medicine on the nails. Afterwards, the medicine will be able to penetrate deeply into the interior of the nails.
If the nail area is infected, spray the medication onto the affected area.
SHAKE WELL BEFORE USE. Store at 5°C to 30°C(41°F to 86F) in a cool dry place. Keep tightly closed and away from sunlight.

INACTIVE INGREDIENT SECTION

water
euphorbia hirta whole
glycerin
hydracrylic acid
pseudolarix amabilis bark
resorcinol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-136979843981316GTIN-13: 6979843981316
EAN-13: 6979843981316
GTIN storage (14 digits): 06979843981316		label1.jpg

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85304-03285304-032-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
PSEUDOLARIX AMABILIS BARK49G13A93VEIACT
RESORCINOLYUL4LO94HKIACT
TOLNAFTATE06KB629TKVACTIB
HYDRACRYLIC ACIDC4ZF6XLD2XIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
EUPHORBIA HIRTA WHOLEL13YF113GNIACT

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
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
ndc (package): 85304-032-01
ndc (product): 85304-032
ndc11 (package): 85304003201
spl id: 5629df38-107a-be4f-e063-6394a90a1c6a
spl set id: 5629df38-1079-be4f-e063-6394a90a1c6a

Reported adverse events (FAERS/openFDA)#

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