Update-85569-013-01--156

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 21:43:25

Label at a glance#

ProductInitial Treatonic FUNGAL NAIL RENEWAL PATCHES

Active ingredientTOLNAFTATE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

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 children under 2years of age unless directed lby a doctor
on dliaper rash

OTC - WHEN USING SECTION

Avoid contact with eyes. do not exceed the recommended daily dosage unless directed by a doctor.

OTC - ASK DOCTOR/PHARMACIST SECTION

iritation 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 Poison Control Center right away.

INDICATIONS & USAGE SECTION

Clean & prepare the affected nail,
Applythe antifungal solution to the affected nail.
Apply the fungus nail patch, Fimly secure the patch to the sides of the toes or fingers,folding the remaining achesive partto fully cover the toes/fingertips.
Leave the patch on for 6-8 hours.Frequency. Use the patches consistently before bed.
Maintain good foothygiene.

OTHER SAFETY INFORMATION

store at 20-25°C(68-77°F)

INACTIVE INGREDIENT SECTION

Water, Glycerin, Sodium Carboxymethyl Cellulose,Butylene Glycol, Urea

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 · 8 matching rows.

Initial Treatonic FUNGAL NAIL RENEWAL PATCHES
Tolnaftate 1%
TOLNAFTATE
CARBOXYMETHYLCELLULOSE SODIUM
UREA
WATER
BUTYLENE GLYCOL
GLYCERIN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
85569-013	85569-013-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TOLNAFTATE	06KB629TKV	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
UREA	8W8T17847W	IACT
WATER	059QF0KO0R	IACT
BUTYLENE GLYCOL	3XUS85K0RA	IACT
GLYCERIN	PDC6A3C0OX	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
2	2026-03-02	full-release	2026-06-01 01:48:23
1	2026-01-21	monthly-update	2026-06-03 17:56:33

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
Initial Treatonic FUNGAL NAIL RENEWAL PATCHES	TOLNAFTATE 1%	100 KARMA INC	48e377b4-abb1-34cf-e063-6294a90a2ea3	2026-07-03	Warnings	Exact identifier ndc (package): 85569-013-01 ndc (product): 85569-013 ndc11 (package): 85569001301 spl id: 55b688c2-20f0-65fa-e063-6294a90afe1c spl set id: 48e377b4-abb1-34cf-e063-6294a90a2ea3

Reported adverse events (FAERS/openFDA)#

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