Nail Antifungal Treatment

Manufacturer
BENM INC.
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:54

Label at a glance#

ProductNail Antifungal Treatment
Active ingredientSALICYLIC ACID, TOLNAFTATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Anti fungal

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate(1%)........................Anti fungal
Salicylic acid(5%) ........................Anti fungal

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:
1. Apply the product twice a day, in the morning and at night.
2. For initial use, soak the affected nail in warm water to soften it. Gently file thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.
3. Use the brush applicator to applythe solution on the affected areas.
4.Visible results will be seen in as little as 2week, continue regular usage toprevent fungus regrowth.

OTC - WHEN USING SECTION

When using this product avoid contact with eyes.

INACTIVE INGREDIENT SECTION

Inactive ingredients:
water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
In case of accidental ingestion,seek medical advice immediately or contact a Poison Control Center right away.

OTC - DO NOT USE SECTION

Do not use on children under 3 years of age unless directed by a doctor.

OTHER SAFETY INFORMATION

OTHER INFORMATION
Store at room temperature 15-30°C (59°-86°F)

WARNINGS SECTION

WARNINGS
For external use only.

INDICATIONS & USAGE SECTION

Uses:
For the effective treatment of nail fungus, discoloration, thickening, splitting,crumbling and brittleness.

OTC - STOP USE SECTION

Stop and ask a doctor if-irritation occurs-there is no improvement
within 4 weeks.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of accidental ingestion,seek medical advice immediately or
contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL-1PACKAGE LABEL-1

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
85283-001-01Nail Antifungal Treatment30 mL in 1 BOTTLELIQUID303

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85283-00185283-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-11-12monthly-update2026-06-03 17:39:37
12025-02-21full-release2026-06-01 00:55:42

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
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
ndc (package): 85283-001-01
ndc (product): 85283-001
ndc11 (package): 85283000101
spl id: 4a9c8198-0dec-8302-e063-6394a90afcb3
spl set id: 2ea24785-c648-4104-e063-6294a90ab12f

Reported adverse events (FAERS/openFDA)#

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