Update-85569-005-01

Drug Facts

Composition & Product

Active Ingredients

Undecylenic Acid (25 g)

Inactive Ingredients

Tea Tree Oil Isopropyl Myristate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-31

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

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

Dosage and 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.

Description

25% Undecylenic Acid

Section 50565-1

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

Section 50566-9

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

Section 50567-7

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

Section 50570-1

Do not use

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

Section 51727-6

Isopropyl Myristate, Tea Tree Oil

Section 51945-4

Section 53413-1

Email: [email protected]

Section 53414-9

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

Section 55105-1

Antifungal

Section 55106-9

25% Undecylenic Acid

Section 60561-8

store at 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

▪ 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.

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

Do not use

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

Section 51727-6 (51727-6)

Isopropyl Myristate, Tea Tree Oil

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email: [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

25% Undecylenic Acid

Section 60561-8 (60561-8)

store at 20-25°C (68-77°F)

Advanced Ingredient Data

[{"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Helps inhibit the growth of fungus. Improves the appearance of nails affected by fungus, including discoloration, thickening, splitting, crumbing, and brittleness.", "34068-7": "▪ 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.", "34071-1": "For external use only", "50565-1": "Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.", "50566-9": "Stop and ask a doctor if ▪ irritation occurs. ▪ there is no improvement within 4 weeks.", "50567-7": "avoid contact with eyes. Do not exceed the recommended daily dosage unless directed by a doctor.", "50570-1": "Do not use on children under 2 years of age unless directed by a doctor on diaper rash", "51727-6": "Isopropyl Myristate, Tea Tree Oil", "53413-1": "Email: service@treatonic.com", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55105-1": "Antifungal", "55106-9": "25% Undecylenic Acid", "60561-8": "store at 20-25°C (68-77°F)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information