Update-85569-005-01

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 21:43:20

Label at a glance#

ProductTOENAIL FUNGUS TREATMENT

Active ingredientUNDECYLENIC ACID

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

25% Undecylenic Acid

OTC - PURPOSE SECTION

Antifungal

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

Do not use

on children under 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 by a doctor.

OTC - STOP USE SECTION

Stop and ask a doctor if ▪ irritation occurs. ▪ there 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

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION 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

Isopropyl Myristate, Tea Tree Oil

OTC - QUESTIONS SECTION

Email: service@treatonic.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

treatment

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

TOENAIL FUNGUS TREATMENT
25% Undecylenic Acid
UNDECYLENIC ACID
TEA TREE OIL
ISOPROPYL MYRISTATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85569-005	85569-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
UNDECYLENIC ACID	K3D86KJ24N	ACTIB
TEA TREE OIL	VIF565UC2G	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2026-03-01	full-release	2026-06-01 01:48:13

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
TOENAIL FUNGUS TREATMENT	25% UNDECYLENIC ACID	100 KARMA INC	3bb000dc-5e6c-b43b-e063-6394a90a63a9	2026-07-03	Warnings	Exact identifier ndc (package): 85569-005-01 ndc (product): 85569-005 ndc11 (package): 85569000501 spl id: 55b676ed-e1d8-1700-e063-6394a90a6ec3 spl set id: 3bb000dc-5e6c-b43b-e063-6394a90a63a9

Reported adverse events (FAERS/openFDA)#

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