Fungal Nail Treatment Maximum Strength Liquid

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (1 g) Undecylenic Acid (25 g)

Inactive Ingredients

Phenoxyethanol Sophora Flavescens Root Tocopherol Water Dimethicone C12-15 Alkyl Lactate Ethylhexylglycerin Alcohol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-19

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Antifungal use on fingernails, toenails, and the immediately adjacentskin.

·Prevents the recurrence of most athlete's foot with daily use.

·For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.

Dosage and Administration

Apply once daily, preferably at bedtime or at least eight hours before

washing. Clean and thoroughly dry the affected area, then use the

applicator brush provided to cover all affected nails. Ensure that the

application is evenly distributed across the entire nail plate.

Description

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID

Section 42229-5

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID

Section 44425-7

OTHER INFORMATIONSHAKE WELL BEFORE USEStore at room temperature 15°-30°C(59°- 86°F)

。Protect from freezing; if freezing occurs.warm to room temperatureKeep tightly closed when not in use

Section 50565-1

If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.

Section 50566-9

Irritation occurs

There is no improvement within 4 weeks

Section 50567-7

avoid contact with the eyes

Section 50570-1

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

Section 51727-6

ALCOHOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

TOCOPHEROL

SOPHORA FLAVESCENS ROOT

PHENOXYETHANOL

WATER

Section 51945-4

Section 55105-1

Anti-fungal and Nail Renewal

Section 55106-9

TOLNAFTATE 1%

UNDECYLENIC ACID 25%

Structured Label Content

Indications and Usage (34067-9)

Antifungal use on fingernails, toenails, and the immediately adjacentskin.

·Prevents the recurrence of most athlete's foot with daily use.

·For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.

Dosage and Administration (34068-7)

Apply once daily, preferably at bedtime or at least eight hours before

washing. Clean and thoroughly dry the affected area, then use the

applicator brush provided to cover all affected nails. Ensure that the

application is evenly distributed across the entire nail plate.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID

Section 44425-7 (44425-7)

OTHER INFORMATIONSHAKE WELL BEFORE USEStore at room temperature 15°-30°C(59°- 86°F)

。Protect from freezing; if freezing occurs.warm to room temperatureKeep tightly closed when not in use

Section 50565-1 (50565-1)

If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.

Section 50566-9 (50566-9)

Irritation occurs

There is no improvement within 4 weeks

Section 50567-7 (50567-7)

avoid contact with the eyes

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

ALCOHOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

TOCOPHEROL

SOPHORA FLAVESCENS ROOT

PHENOXYETHANOL

WATER

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anti-fungal and Nail Renewal

Section 55106-9 (55106-9)

TOLNAFTATE 1%

UNDECYLENIC ACID 25%

Advanced Ingredient Data

[{"name": "PHENOXYETHANOL", "unii": "HIE492ZZ3T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SOPHORA FLAVESCENS ROOT", "unii": "IYR6K8KQ5K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOCOPHEROL", "unii": "R0ZB2556P8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TOLNAFTATE", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "C12-15 ALKYL LACTATE", "unii": "GC844VRD7E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ETHYLHEXYLGLYCERIN", "unii": "147D247K3P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "UNDECYLENIC ACID", "unii": "K3D86KJ24N", "classCode": "ACTIB", "strengthNumerator": "25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Antifungal use on fingernails, toenails, and the immediately adjacentskin. ·Prevents the recurrence of most athlete's foot with daily use. ·For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.", "34068-7": "Apply once daily, preferably at bedtime or at least eight hours before washing. Clean and thoroughly dry the affected area, then use the applicator brush provided to cover all affected nails. Ensure that the application is evenly distributed across the entire nail plate.", "34071-1": "For external use only.", "42229-5": "FUNGAL NAIL TREATMENT MAXIMUM STRENGTH LIQUID", "44425-7": "OTHER INFORMATIONSHAKE WELL BEFORE USEStore at room temperature 15°-30°C(59°- 86°F) 。Protect from freezing; if freezing occurs.warm to room temperatureKeep tightly closed when not in use", "50565-1": "If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.", "50566-9": "Irritation occurs There is no improvement within 4 weeks", "50567-7": "avoid contact with the eyes", "50570-1": "on children under 2 years of age unless directed by a doctor", "51727-6": "ALCOHOL DIMETHICONE C12-15 ALKYL LACTATE ETHYLHEXYLGLYCERIN TOCOPHEROL SOPHORA FLAVESCENS ROOT PHENOXYETHANOL WATER", "55105-1": "Anti-fungal and Nail Renewal", "55106-9": "TOLNAFTATE 1% UNDECYLENIC ACID 25%"}

Fungal Nail Treatment Maximum Strength Liquid

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information