TOENAIL FUNGUS TREATMENT- 25% undecylenic acid liquid

TOENAIL FUNGUS TREATMENT by

Drug Labeling and Warnings

TOENAIL FUNGUS TREATMENT 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

PURPOSE

Antifungal

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

Do not use

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

avoid contact with eyes. Do not exceed the recommended daily dosage unless directed by a doctor.

Stop and ask a doctor if ▪ irritation occurs. ▪ there is no improvement within 4 weeks.

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

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

▪ 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

Isopropyl Myristate, Tea Tree Oil

QUESTIONS

Email: service@treatonic.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOENAIL FUNGUS TREATMENT 
25% undecylenic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	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
TEA TREE OIL (UNII: VIF565UC2G)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85569-005-01	30 mL in 1 CARTON; Type 0: Not a Combination Product	08/31/2025

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

Labeler - 100 KARMA INC (120186232)

Registrant - 100 KARMA INC (120186232)