Update 85569-015-01--151

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 21:43:15

Label at a glance#

ProductTreatonic Nailtonic Repair Pens

Active ingredientUNDECYLENIC ACID

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

25% Undecylenic Acid(Treatment)

OTC - PURPOSE SECTION

Antifungal

DOSAGE & ADMINISTRATION SECTION

For the effective treatment of nail fungus, discoloration, thickening, splitting, crmbing, 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

Avoid contact with the eyes

OTC - ASK DOCTOR SECTION

Irritation occurs.
There is no improvement within 4 weeks.

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.

INDICATIONS & USAGE SECTION

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.

OTHER SAFETY INFORMATION

Store at 20-25°C(68-77°F)

INACTIVE INGREDIENT SECTION

Water, Euphorbia Hirta Whole, Glycerin, Hydracrylic Acid, Isopropyl Myristate,Tea Tree Oil, Pseudolarix Amabilis Bark, Resorcinol

OTC - QUESTIONS SECTION

Email: service@treatonic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Treatonic Nailtonic Repair Pens
25% Undecylenic Acid
ISOPROPYL MYRISTATE
GLYCERIN
RESORCINOL
HYDRACRYLIC ACID
EUPHORBIA HIRTA WHOLE
PSEUDOLARIX AMABILIS BARK
TEA TREE OIL
UNDECYLENIC ACID
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85569-015	85569-015-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
GLYCERIN	PDC6A3C0OX	IACT
RESORCINOL	YUL4LO94HK	IACT
HYDRACRYLIC ACID	C4ZF6XLD2X	IACT
EUPHORBIA HIRTA WHOLE	L13YF113GN	IACT
PSEUDOLARIX AMABILIS BARK	49G13A93VE	IACT
TEA TREE OIL	VIF565UC2G	IACT
UNDECYLENIC ACID	K3D86KJ24N	ACTIB
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2026-02-12	full-release	2026-06-01 01:48:47

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
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	Exact identifier ndc (package): 85569-015-01 ndc (product): 85569-015 ndc11 (package): 85569001501 spl id: 55b683b8-9807-67b7-e063-6294a90a6af9 spl set id: 4a9c32b3-e78d-3c85-e063-6394a90a7bf2

Reported adverse events (FAERS/openFDA)#

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