OTC - ACTIVE INGREDIENT SECTION
25% Undecylenic Acid (Treatment)
Tolnaftate 1% (Patch)
Update 85569-016-01--149
- Manufacturer
- 100 KARMA INC
- Effective date
- 2026-07-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:43:20
Label at a glance#
ProductTreatonic TONENAIL FUNGUS TREATONIC kit.
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Antifungal
DOSAGE & ADMINISTRATION SECTION
Helps inhibit the growth of fungus.
Improves the appearance of nails affected by fungus, including discoloration, thickening,splitting, crumbing, and brittleness.
WARNINGS SECTION
For external use only
OTC - DO NOT USE SECTION
- on childrenunder 2 years of age unless directed by a doctor
- on diaper rash
OTC - WHEN USING SECTION
Avoid contact with eyes. Do not exceed the recommended daily dosage unless directed bya doctor.
OTC - ASK DOCTOR SECTION
- Irritation occurs.
- There is no improvement within 4 weeks.
OTC - PREGNANCY OR BREAST FEEDING SECTION
ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
In case of accidental ingestion, seek medical advice immediately or contact a PoisonControl Center right away.
INDICATIONS & USAGE SECTION
Directions (Treatment)
- Wash affected area and dry thoroughly.
- Apply a thin layer of the product over the affected area(around the nails and underneath nail tips) twice daily or directed by a doctor.
- Supervise children in the use of this product.
Directions (Patch)
- Clean & prepare the affected nail.
- Apply the antifungal solution to the affected nall.
- Apply the fungusnail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips,
- Leave the patch on for 6-8 hours. Frequency. Use the patches consistently before bed.
- Maintain good foot hygiene.
OTHER SAFETY INFORMATION
Store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients (Treatment): Isopropyl Myristate, Tea Tree Oil
Inactive ingredients (Patch): Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea
OTC - QUESTIONS SECTION
Email: service@treatonic.com
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0860015148025 | GTIN-13: 0860015148025 EAN-13: 0860015148025 GTIN-12: 860015148025 UPC-A: 860015148025 GTIN storage (14 digits): 00860015148025 | package.jpg |
Products#
Every source-derived product name is available through these pages.
- Treatonic TONENAIL FUNGUS TREATONIC kit.
- 25% Undecylenic Acid and Tolnaftate 1%
- Treatonic Nailtonic Repair Pens
- 25% Undecylenic Acid
- WATER
- UNDECYLENIC ACID
- HYDRACRYLIC ACID
- PSEUDOLARIX AMABILIS BARK
- TEA TREE OIL
- GLYCERIN
- EUPHORBIA HIRTA WHOLE
- RESORCINOL
- ISOPROPYL MYRISTATE
- Initial Treatonic FUNGAL NAIL RENEWAL PATCHES
- Tolnaftate 1%
- BUTYLENE GLYCOL
- CARBOXYMETHYLCELLULOSE SODIUM
- TOLNAFTATE
- UREA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85569-016 | 85569-016-01 |
| 85569-015 | |
| 85569-013 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| HYDRACRYLIC ACID | C4ZF6XLD2X | IACT |
| PSEUDOLARIX AMABILIS BARK | 49G13A93VE | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| EUPHORBIA HIRTA WHOLE | L13YF113GN | IACT |
| RESORCINOL | YUL4LO94HK | IACT |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| WATER | 059QF0KO0R | IACT |
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| TOLNAFTATE | 06KB629TKV | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| UREA | 8W8T17847W | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2026-03-03 | full-release | 2026-06-01 01:51:05 |
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 |
|---|---|---|---|---|---|---|
| Treatonic Nailtonic Repair Pens | 25% UNDECYLENIC ACID | 100 KARMA INC | 4a9c32b3-e78d-3c85-e063-6394a90a7bf2 | 2026-07-03 | Warnings | 85569-015 |
| Initial Treatonic FUNGAL NAIL RENEWAL PATCHES | TOLNAFTATE 1% | 100 KARMA INC | 48e377b4-abb1-34cf-e063-6294a90a2ea3 | 2026-07-03 | Warnings | 85569-013 |
| Treatonic TONENAIL FUNGUS TREATONIC kit. | 25% UNDECYLENIC ACID AND TOLNAFTATE 1% | 100 KARMA INC | 4c197131-9ca8-6024-e063-6294a90aa9cb | 2026-07-03 | Warnings | 85569-016-01 85569-016 85569001601 55b6974f-0c2c-80bd-e063-6294a90a5a37 4c197131-9ca8-6024-e063-6294a90aa9cb |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.