SPL v2
SPL
SPL Set ID 1bf024c8-666d-3315-e063-6294a90a24f6
Route
TOPICAL
Published
Effective Date 2024-06-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (10 mg)
Inactive Ingredients
Garlic Melaleuca Alternifolia (tea Tree) Leaf Oil Allantoin Glycerin Cnidium Monnieri Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-25

Description

TOLNAFTATE 1%

Purpose

bacteriostatic, sterilizing


Medication Information

Purpose

bacteriostatic, sterilizing

Description

TOLNAFTATE 1%

Use

Use for fungal nail infections

Stop Use

Stop use and ask a doctor if irritation or rash occurs

Warnings

For external use only

Ask Doctor

Do not put in eyes,lfit accidentally gets into your eyes, rinse with water or seek medical advice.lfirritation or rash occurs, discontinue use and ask a doctor. if swallowed, get medical help orcontact a Poison Control Centerimmediate.

Directions

Apply this product to the desired nail area, 1-2 times a day. Keep using it.

Avoid light, airtight, and store in a cool and dry place.

Do Not Use

It is prohibited for those who are allergic to this product and pregnant women, and should be used with caution on open wounds.

When Using

Do not put in eyes,If it accidentally gets into your eyes, rinse with water or seek medical advice.If irritation or rash occurs, discontinue use and ask a doctor. If swallowed, get medical help or contact a Poison Control Center immediately

Active Ingredient

TOLNAFTATE 1%

Inactive Ingredients

Glycerin, Allantoin,Allium Sativum (Garlic) Bulb Extract,Cnidium,Monnieri Fruit Oil,Melaleuca Alternifolia (Tea Tree) Leaf oil

Keep Out of Reach of Children

Please keep this product out of reach of children

Dosage & Administration Section

One patch per day, each patch contains 1 mg of tolnaftate

Package Label.principal Display Panel


Structured Label Content

Use

Use for fungal nail infections

Purpose

bacteriostatic, sterilizing

Stop Use

Stop use and ask a doctor if irritation or rash occurs

Warnings

For external use only

Ask Doctor

Do not put in eyes,lfit accidentally gets into your eyes, rinse with water or seek medical advice.lfirritation or rash occurs, discontinue use and ask a doctor. if swallowed, get medical help orcontact a Poison Control Centerimmediate.

Directions

Apply this product to the desired nail area, 1-2 times a day. Keep using it.

Avoid light, airtight, and store in a cool and dry place.

Do Not Use (Do not use)

It is prohibited for those who are allergic to this product and pregnant women, and should be used with caution on open wounds.

When Using

Do not put in eyes,If it accidentally gets into your eyes, rinse with water or seek medical advice.If irritation or rash occurs, discontinue use and ask a doctor. If swallowed, get medical help or contact a Poison Control Center immediately

Active Ingredient (ACTIVE INGREDIENT)

TOLNAFTATE 1%

Inactive Ingredients (Inactive ingredients)

Glycerin, Allantoin,Allium Sativum (Garlic) Bulb Extract,Cnidium,Monnieri Fruit Oil,Melaleuca Alternifolia (Tea Tree) Leaf oil

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Please keep this product out of reach of children

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

One patch per day, each patch contains 1 mg of tolnaftate

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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