SPL v1
SPL
SPL Set ID 15aa510b-31d4-e158-e063-6394a90a3c2c
Route
TOPICAL
Published
Effective Date 2024-04-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1.8 g)
Inactive Ingredients
Angelica Dahurica Leaf Water Alcohol Laurocapram Poliglusam Propanediol Chlorhexidine Sorbitol Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-09

Description

TOLNAFTATE 1%

Purpose

Fungal Nail Renewal


Medication Information

Purpose

Fungal Nail Renewal

Description

TOLNAFTATE 1%

Dosage

Repeat this process 2-3 times daily until a healthy nail starts regenerating gradually.

For optimal effects, maintain usage for continuous 6 weeks.

Section 51945-4

Storage

Keep away from direct sunlight or heat!

Store at room temperature of 15°-30℃ (59°-86℉)

Warnings

For external use only, do not eat.

Avoid eye contact. Keep your skin dry and clean.

No use on severely ulcerated skin.

This product is not a substitute for medication.

Do not use it for children under 2 years old unless with a doctor's advice.

How to Use

1. First soak your feet in warm water for 5 minutes. Then dry your toes thoroughly.

2. Employ a fingernail clipper (not included) and a nail file to meticulously eliminate as much damaged nail area as possible. This key step maximizes the absorption potential of our nail fungus treatment liquid.

3. Apply a proper dosage of the liquid to the areas requiring repair.

Active Ingredient

TOLNAFTATE 1%

Inactive Ingredient

ALCOHOL 9ml

ANGELICA DAHURICA LEAF 1.8g

SORBITOL 15g

SALICYLIC ACID 4.7g

LAUROCAPRAM 0.3g

PROPANEDIOL 6g

CHLORHEXIDINE 0.2g

POLIGLUSAM 3.4g

WATER 58.6ml

When Using This Product

This product can facilitate the recovery of nails suffering from nail fungus. It can aid in averting recurrent athlete's foot through daily usage.

Stop Use and Ask A Doctor If

You are pregnant or have a plan to get pregnant while using the product.

You are allergic to this product (such as itching, rash swelling of the lips, eyelids and shortness of breath).

Keep Out of Reach of Children

Do not use it for children under 2 years old unless with a doctor's advice.


Structured Label Content

Dosage (DOSAGE)

Repeat this process 2-3 times daily until a healthy nail starts regenerating gradually.

For optimal effects, maintain usage for continuous 6 weeks.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Fungal Nail Renewal

Storage (STORAGE)

Keep away from direct sunlight or heat!

Store at room temperature of 15°-30℃ (59°-86℉)

Warnings (WARNINGS)

For external use only, do not eat.

Avoid eye contact. Keep your skin dry and clean.

No use on severely ulcerated skin.

This product is not a substitute for medication.

Do not use it for children under 2 years old unless with a doctor's advice.

How to Use (HOW TO USE)

1. First soak your feet in warm water for 5 minutes. Then dry your toes thoroughly.

2. Employ a fingernail clipper (not included) and a nail file to meticulously eliminate as much damaged nail area as possible. This key step maximizes the absorption potential of our nail fungus treatment liquid.

3. Apply a proper dosage of the liquid to the areas requiring repair.

Active Ingredient (ACTIVE INGREDIENT)

TOLNAFTATE 1%

Inactive Ingredient (INACTIVE INGREDIENT)

ALCOHOL 9ml

ANGELICA DAHURICA LEAF 1.8g

SORBITOL 15g

SALICYLIC ACID 4.7g

LAUROCAPRAM 0.3g

PROPANEDIOL 6g

CHLORHEXIDINE 0.2g

POLIGLUSAM 3.4g

WATER 58.6ml

When Using This Product (WHEN USING THIS PRODUCT)

This product can facilitate the recovery of nails suffering from nail fungus. It can aid in averting recurrent athlete's foot through daily usage.

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

You are pregnant or have a plan to get pregnant while using the product.

You are allergic to this product (such as itching, rash swelling of the lips, eyelids and shortness of breath).

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

Do not use it for children under 2 years old unless with a doctor's advice.


Advanced Ingredient Data


Raw Label Data

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