Storage and handling
Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).
85038-001 Toenail Fungus Treatment Extra Strength Pen
- Manufacturer
- Lianjiang Shanlilai E-commerce Co., Ltd.
- Effective date
- 2026-04-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-06-01 01:52:27
Label at a glance#
ProductToenail Fungus Treatment Extra Strength Pen
Active ingredientTOLNAFTATE, UNDECYLENIC ACID
Label structure13 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Toenail Fungus Treatment Extra Strength Pen
OTC - ACTIVE INGREDIENT SECTION
TOLNAFTATE 1%
UNDECYLENIC ACID 25%
OTC - PURPOSE SECTION
Anti-fungal
INDICATIONS & USAGE SECTION
For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.
WARNINGS SECTION
For external use only.
OTC - DO NOT USE SECTION
children under 2 years of age.
pregnant or if there is any allergic reaction to this produce.
OTC - WHEN USING SECTION
Avoid contact with eyes. in case of contact, rinse thoroughly
with water.
OTC - STOP USE SECTION
lrritation occurs or discomfort persists.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of accidental ingestion, seek medical advice
immediately or contact a Poison Control center right away.
DOSAGE & ADMINISTRATION SECTION
Wash and dry your nails before use, Remove the capcovering the brush of the pen.
Twist the end of the pen clockwise to dispense the liquidonto the brush.
Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.
Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.
STORAGE AND HANDLING SECTION
Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).
INACTIVE INGREDIENT SECTION
ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 85038-001-01 | Toenail Fungus Treatment Extra Strength Pen | 3 in 1 PACKAGE | LIQUID | 3 | 2 | |
| 85038-001-01 | Toenail Fungus Treatment Extra Strength Pen | 5 mL in 1 BOTTLE | LIQUID | 5 | 2 |
Products#
Every source-derived product name is available through these pages.
- Toenail Fungus Treatment Extra Strength Pen
- TOLNAFTATE, UNDECYLENIC ACID
- SAFFLOWER OIL
- TOCOPHEROL
- WATER
- CETOSTEARYL ALCOHOL
- TOLNAFTATE
- PROPYLENE GLYCOL
- UNDECYLENIC ACID
- ALCOHOL
- TEA TREE OIL
- DIMETHICONE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85038-001 | 85038-001-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SAFFLOWER OIL | 65UEH262IS | IACT |
| TOCOPHEROL | R0ZB2556P8 | IACT |
| WATER | 059QF0KO0R | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| TOLNAFTATE | 06KB629TKV | ACTIB |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Toenail Fungus Treatment Extra Strength Pen | TOLNAFTATE, UNDECYLENIC ACID | Lianjiang Shanlilai E-commerce Co., Ltd. | 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6 | 2026-04-02 | Warnings | 85038-001-01 85038-001 85038000101 4e77e84f-737b-3e6b-e063-6394a90a3bbc 28fbcc50-a3ac-d6d1-e063-6294a90aa2b6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.