TREATONIC TOENAIL FUNGUS TREATMENT KIT- toenail fungus treatment kit

Treatonic Toenail Fungus Treatment Kit by

Drug Labeling and Warnings

Treatonic Toenail Fungus Treatment Kit by is a Otc medication manufactured, distributed, or labeled by 100 KARMA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

25% Undecylenic Acid
1% Tolnaftate

PURPOSE

Anti-fungal

INDICATIONS & USAGE

• Helps Inhibit the growth of fungus.
• Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.
  

WARNINGS

For external use only

• on children under 2 years of age unless directed by a doctor.
• on diaper rash

when using this product:
avoid contact with eyes. Do not exceed the recommended daily dosge unless directed by a doctor.

Stop use and ask a doctor if

• irritation occurs
• this is no improvement within 4 weeks.

If pregnant or breast feeding, ask a health professional before use.

In case of accidental ingestion, seek medical advice immediately or contact a poison control center right away.

DOSAGE & ADMINISTRATION

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

(Treatment) Isopropyl Myristate, Tea Tree Oil

(Patch) Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea

QUESTIONS

Email: service@treatonic.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TREATONIC TOENAIL FUNGUS TREATMENT KIT 
toenail fungus treatment kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85569-010

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85569-010-01	1 in 1 KIT; Type 0: Not a Combination Product	09/10/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1		1
Part 2		2

Part 1 of 2

FUNGAL NAIL NIGHTTIME RENEWAL PATCHES 
tolnaftate 1% patch

Product Information
Item Code (Source)	NDC: 85569-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	1 g  in 100

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
UREA (UNII: 8W8T17847W)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/31/2025

Part 2 of 2

TOENAIL FUNGUS TREATMENT 
25% undecylenic acid liquid

Product Information
Item Code (Source)	NDC: 85569-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TEA TREE OIL (UNII: VIF565UC2G)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	08/31/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M005	09/10/2025

Labeler - 100 KARMA INC (120186232)