OTC - PURPOSE SECTION
Anti fungal
Anti fungal
Tolnaftate(1%)........................Anti fungal
Salicylic acid(5%) ........................Anti fungal
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.
When using this product avoid contact with eyes.
Inactive ingredients:
water,euphorbia hirta whole,glycerin, hydracrylic acid,pseudolarix amabilis bark,resorcinol
Keep out of reach of children.
In case of accidental ingestion,seek medical advice immediately or contact a Poison Control Center right away.
Do not use on children under 3 years of age unless directed by a doctor.
OTHER INFORMATION
Store at room temperature 15-30°C (59°-86°F)
WARNINGS
For external use only.
Uses:
For the effective treatment of nail fungus, discoloration, thickening, splitting,crumbling and brittleness.
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.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dea2eded-d1e7-46bb-9a3d-f8dc20de6277 | Product name | 1 | 20190408 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85283-001-01 | Nail Antifungal Treatment | 30 mL in 1 BOTTLE | LIQUID | 30 | 3 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 85283-001 | 85283-001-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PSEUDOLARIX AMABILIS BARK | 49G13A93VE | IACT |
| HYDRACRYLIC ACID | C4ZF6XLD2X | IACT |
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
| EUPHORBIA HIRTA WHOLE | L13YF113GN | IACT |
| TOLNAFTATE | 06KB629TKV | ACTIB |
| RESORCINOL | YUL4LO94HK | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2025-11-12 | monthly-update | 2026-06-03 17:39:37 |
| 1 | 2025-02-21 | full-release | 2026-06-01 00:55:42 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Nail Antifungal Treatment | TOLNAFTATE 1% FUNGI NAIL | BENM INC. | 2ea24785-c648-4104-e063-6294a90ab12f | 2026-02-12 | Warnings | 85283-001-01 85283-001 85283000101 4a9c8198-0dec-8302-e063-6394a90afcb3 2ea24785-c648-4104-e063-6294a90ab12f |
Adverse event summaries are temporarily unavailable. Other product information remains available.