Update-85569-009-01

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (1 g)

Inactive Ingredients

Water Glycerin Butylene Glycol Carboxymethylcellulose Sodium Urea

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-31

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

▪ 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.

Dosage and Administration

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

Description

Tolnaftate 1%

Section 50565-1

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Section 50567-7

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

Section 50569-3

mirritation occurs.
there is no improvement within 4 weeks.

Section 50570-1

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

Section 51727-6

Water, Glycerin, Sodium Carboxymethy Cellulose, Butylene clycol, Urea

Section 51945-4

Section 53413-1

Email: [email protected]

Section 53414-9

ask a health professional before use.

Section 55105-1

Antifungal

Section 55106-9

Tolnaftate 1%

Section 60561-8

store at 20-25°C (68-77°F)

Structured Label Content

Indications and Usage (34067-9)

▪ 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.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

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

Section 50569-3 (50569-3)

mirritation occurs.
there is no improvement within 4 weeks.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Water, Glycerin, Sodium Carboxymethy Cellulose, Butylene clycol, Urea

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Email: [email protected]

Section 53414-9 (53414-9)

ask a health professional before use.

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Tolnaftate 1%

Section 60561-8 (60561-8)

store at 20-25°C (68-77°F)

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "1"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UREA", "unii": "8W8T17847W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "▪ 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.", "34068-7": "Helps inhibit the growth of fungus. lmproves the appearance of nails affected by fungus,including discoloration,thickening, splitting, crumbing, and brittleness.", "34071-1": "For external use only", "50565-1": "in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.", "50567-7": "Avoid contact with eyes. do not exceed the recommended daly dosage unless directed by a doctor.", "50569-3": "mirritation occurs. there is no improvement within 4 weeks.", "50570-1": "on children under 2 years ofage unless directed by a doctor on diaper rash", "51727-6": "Water, Glycerin, Sodium Carboxymethy Cellulose, Butylene clycol, Urea", "53413-1": "Email: service@treatonic.com", "53414-9": "ask a health professional before use.", "55105-1": "Antifungal", "55106-9": "Tolnaftate 1%", "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