SPL v1
SPL
SPL Set ID 1ca6cb6f-778b-bc6b-e063-6394a90a7b72
Route
TOPICAL
Published
Effective Date 2024-06-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Garlic Melaleuca Alternifolia (tea Tree) Leaf Oil Allantoin Cnidium Monnieri Fruit Oil Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-07

Description

Tolnaftate 1%

Purpose

bacteriostatic, sterilizing.


Medication Information

Purpose

bacteriostatic, sterilizing.

Description

Tolnaftate 1%

Use

Use for fungal nail infections.

Section 51945-4

Stop Use

Stop use and ask a doctor if irritation or rash occurs.

Warnings

For external use only

Ask Doctor

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

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 eves,lf it accidentally gets into your eyes, rinse with water or seek medical advice,f irritation or rash occurs, discontinye use and ask a doctor. lf swallowed, get medical help or contact a Poison Control Center immediately

Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Glycerin, Alantoin,Alium Sativum (Garlic) Bulb Extract, Cnidium,Monnieri Fruit Oil,Melaleuca Alternifolia (Tea Tree) Leaf oi

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


Structured Label Content

Use

Use for fungal nail infections.

Section 51945-4 (51945-4)

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 eves,lfit accidentally gets into your eyes, rinse with water or seekmedical advice.lfirritation or rash occurs, discontinue use and ask a doctor. if swallowed, get medical help orcontact a Poison Control Centerimmediatel

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 eves,lf it accidentally gets into your eyes, rinse with water or seek medical advice,f irritation or rash occurs, discontinye use and ask a doctor. lf swallowed, get medical help or contact a Poison Control Center immediately

Active Ingredients (Active ingredients)

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

Glycerin, Alantoin,Alium Sativum (Garlic) Bulb Extract, Cnidium,Monnieri Fruit Oil,Melaleuca Alternifolia (Tea Tree) Leaf oi

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)