SPL v1
SPL
SPL Set ID 1513d791-6b4b-1394-e063-6394a90a98a7
Route
TOPICAL
Published
Effective Date 2024-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mL)
Inactive Ingredients
Alcohol Angelica Dahurica Leaf Sorbitol Salicylic Acid Laurocapram Propanediol Chlorhexidine Poliglusam Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-02

Description

Tolnaftate 1%

Purpose

Fungal Nail Renewal


Medication Information

Purpose

Fungal Nail Renewal

Description

Tolnaftate 1%

Dosage

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

Section 51945-4

Storage

Store at room temperature

15°-30℃(59°-86℉).

Warnings

For extemmal use only, do not ingest.

Avoid eye contact: maintaln dry and clean skin.

Exercise caution when using on severely ulcerated skin.

This product is not a substitute for medication.

Do not use on children under 2 years of age unless directed by a doctor.

How to Use

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

Active Ingredient

Tolnaftate 1%

Inactive Ingredient

WATER 58.6 mL

POLIGLUSAM 3.4 g

CHLORHEXIDINE 0.2 g

PROPANEDIOL 6 g

LAUROCAPRAM 0.3 g

SALICYLIC ACID 4.7 g

SORBITOL 15 g

ANGELICA DAHURICA LEAF 1.8 g

ALCOHOL 10 mL

When Using This Product

Fungal nails, Athlete's Foot, Tinea ManuumJock ltch, Ringworm caused by fungus andbacterial.

Helps prevent most athlete's foot with daily use.

For effective relief of itching, burning and cracking.

Stop Use and Ask A Doctor If

You become pregnant or are planning.to get pregnant while using the product.

You are allergic to this product (such a itching, rash swelling of the lips, eyelidsand shortness of breath).

Keep Out of Reach of Children

Keep away from direct sunlight or heat!


Structured Label Content

Dosage (DOSAGE)

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Fungal Nail Renewal

Storage (STORAGE)

Store at room temperature

15°-30℃(59°-86℉).

Warnings (WARNINGS)

For extemmal use only, do not ingest.

Avoid eye contact: maintaln dry and clean skin.

Exercise caution when using on severely ulcerated skin.

This product is not a substitute for medication.

Do not use on children under 2 years of age unless directed by a doctor.

How to Use (HOW TO USE)

1.Apply the product twice a day, in themorning and at night.

2.For initial use, soak the affected nail inwam water to soften it. Gently file the naito make it thinner and remove dirt. beingcautious not to harm the nail bed. Applythe product after this step.

3.After the first application, repeat ever2-3 days. File the surface of the affectednail and continue regular usage.w'In case of ingestion, seek medical.assistance or contact a poison controlcenter immediately.

Active Ingredient (ACTIVE INGREDIENT)

Tolnaftate 1%

Inactive Ingredient (INACTIVE INGREDIENT)

WATER 58.6 mL

POLIGLUSAM 3.4 g

CHLORHEXIDINE 0.2 g

PROPANEDIOL 6 g

LAUROCAPRAM 0.3 g

SALICYLIC ACID 4.7 g

SORBITOL 15 g

ANGELICA DAHURICA LEAF 1.8 g

ALCOHOL 10 mL

When Using This Product (WHEN USING THIS PRODUCT)

Fungal nails, Athlete's Foot, Tinea ManuumJock ltch, Ringworm caused by fungus andbacterial.

Helps prevent most athlete's foot with daily use.

For effective relief of itching, burning and cracking.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

You become pregnant or are planning.to get pregnant while using the product.

You are allergic to this product (such a itching, rash swelling of the lips, eyelidsand shortness of breath).

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Keep away from direct sunlight or heat!


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)