OTC - ACTIVE INGREDIENT SECTION
25% Undecylenic Acid
1% Tolnaftate
Update-85569-010-01
- Manufacturer
- 100 KARMA INC
- Effective date
- 2026-07-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:43:21
Label at a glance#
ProductTreatonic Toenail Fungus Treatment Kit
Active ingredientUNDECYLENIC ACID, TOLNAFTATE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
Anti-fungal
INDICATIONS & USAGE 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 children under 2 years of age unless directed by a doctor.
- on diaper rash
OTC - WHEN USING SECTION
when using this product:
avoid contact with eyes. Do not exceed the recommended daily dosge unless directed by a doctor.
OTC - STOP USE SECTION
Stop use and ask a doctor if
- irritation occurs
- this is no improvement within 4 weeks.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding, 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 poison control center right away.
DOSAGE & ADMINISTRATION 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 nail.
- Apply the fungus nail 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
(Treatment) Isopropyl Myristate, Tea Tree Oil
(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 | 0860014042591 | GTIN-13: 0860014042591 EAN-13: 0860014042591 GTIN-12: 860014042591 UPC-A: 860014042591 GTIN storage (14 digits): 00860014042591 | kit.jpg |
Products#
Every source-derived product name is available through these pages.
- Treatonic Toenail Fungus Treatment Kit
- Toenail Fungus Treatment
- 25% Undecylenic Acid
- UNDECYLENIC ACID
- ISOPROPYL MYRISTATE
- TEA TREE OIL
- FUNGAL NAIL NIGHTTIME RENEWAL PATCHES
- tolnaftate 1%
- TOLNAFTATE
- WATER
- GLYCERIN
- CARBOXYMETHYLCELLULOSE SODIUM
- UREA
- BUTYLENE GLYCOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 85569-010 | 85569-010-01 |
| 85569-005 | |
| 85569-009 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| UNDECYLENIC ACID | K3D86KJ24N | ACTIB |
| ISOPROPYL MYRISTATE | 0RE8K4LNJS | IACT |
| TEA TREE OIL | VIF565UC2G | IACT |
| TOLNAFTATE | 06KB629TKV | ACTIB |
| WATER | 059QF0KO0R | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| UREA | 8W8T17847W | IACT |
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2026-03-01 | full-release | 2026-06-01 01:48:21 |
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 |
|---|---|---|---|---|---|---|
| FUNGAL NAIL NIGHTTIME RENEWAL PATCHES | TOLNAFTATE 1% | 100 KARMA INC | 3b9ab6e0-8773-f909-e063-6394a90ac1c9 | 2026-07-03 | Warnings | 85569-009 |
| TOENAIL FUNGUS TREATMENT | 25% UNDECYLENIC ACID | 100 KARMA INC | 3bb000dc-5e6c-b43b-e063-6394a90a63a9 | 2026-07-03 | Warnings | 85569-005 |
| Treatonic Toenail Fungus Treatment Kit | TOENAIL FUNGUS TREATMENT | 100 KARMA INC | 3d4bbc65-955f-8fd8-e063-6294a90adc44 | 2026-07-03 | Warnings | 85569-010-01 85569-010 85569001001 55b683b8-9806-67b7-e063-6294a90a6af9 3d4bbc65-955f-8fd8-e063-6294a90adc44 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.