83766-108 Erwcnmie Toenail Fungus Treatment Pen

83766-108 Erwcnmie Toenail Fungus Treatment Pen
SPL v1
SPL
SPL Set ID 3dce0c33-d4f3-5135-e063-6394a90a85a6
Route
TOPICAL
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g) Undecylenic Acid (25 g)
Inactive Ingredients
Ethylhexylglycerin Propylene Glycol Laurocapram Dimethicone Glycerin C12-15 Alkyl Lactate Phenoxyethanol Sophora Flavescens Root Tocopherol Water Polyethylene Glycol, Unspecified Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-02
Description

Tolnaftate 1% UNDECYLENIC ACID 25%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the effective treatment of nail fungus-including discoloration,.

thickening, splitting, crumbling, and brittleness.

Dosage and Administration

1.Wash and dry your nails thoroughly before applying the product.Remove the cap that covers the brush.

2.Twist the end of the pen clockwise to dispense the liquid onto thebrush.

3.Apply the liquid three times to the areas requiring treatment,ensuring complete coverage of all affected parts.

4.Use 2 times daily for 2-4 weeks, depending on the condition beingtreated.

Description

Tolnaftate 1% UNDECYLENIC ACID 25%

Section 50565-1

If accidental ingestion occurs, seek medical attention immediatelyand contact a Poison Control Center.

Section 50566-9

lrritation occurs or discomfort persists.

Section 50567-7

Avoid contact with eyes. lf in eyes, rinse thoroughly with water.

Section 50570-1

Children under 2 years of age.

Pregnant or if there is any allergic reaction to this produce.

Section 51727-6

ALCOHOL

POLYETHYLENE GLYCOL

PROPYLENE GLYCOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

GLYCERIN

LAUROCAPRAM

SOPHORA FLAVESCENS ROOT

TOCOPHEROL

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)

For the effective treatment of nail fungus-including discoloration,.

thickening, splitting, crumbling, and brittleness.

Dosage and Administration (34068-7)

1.Wash and dry your nails thoroughly before applying the product.Remove the cap that covers the brush.

2.Twist the end of the pen clockwise to dispense the liquid onto thebrush.

3.Apply the liquid three times to the areas requiring treatment,ensuring complete coverage of all affected parts.

4.Use 2 times daily for 2-4 weeks, depending on the condition beingtreated.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

If accidental ingestion occurs, seek medical attention immediatelyand contact a Poison Control Center.

Section 50566-9 (50566-9)

lrritation occurs or discomfort persists.

Section 50567-7 (50567-7)

Avoid contact with eyes. lf in eyes, rinse thoroughly with water.

Section 50570-1 (50570-1)

Children under 2 years of age.

Pregnant or if there is any allergic reaction to this produce.

Section 51727-6 (51727-6)

ALCOHOL

POLYETHYLENE GLYCOL

PROPYLENE GLYCOL

DIMETHICONE

C12-15 ALKYL LACTATE

ETHYLHEXYLGLYCERIN

GLYCERIN

LAUROCAPRAM

SOPHORA FLAVESCENS ROOT

TOCOPHEROL

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.407937 · Updated: 2026-03-14T23:09:57.827589