SPL v1
SPL
SPL Set ID 23620e08-7c5a-1d3b-e063-6394a90a43a2
Route
EXTRACORPOREAL
Published
Effective Date 2024-07-17
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 Water Allantoin Glycerin Cnidium Monnieri Fruit

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-05

Description

Tolnaftate 1%

Purpose

Anti-fungal


Medication Information

Purpose

Anti-fungal

Description

Tolnaftate 1%

Use

Proven effective in the treatment of most athlete’s foot (tinea pedis)and ringworm(tinea corporis).

Section 51945-4

Stop Use

If discomfort persists.

Warnings

For external use only

Ask Doctor

before you use If you have diabetes or poor blood circulation.

Do Not Use

■On irritated skin and any area that is infected or reddened.

■If pregnant or if there is any allergic reaction to this product.

When Using

avoid contact witheyes

Active Ingredients

Tolnaftate 1%

Inactive Ingredients

Melaleuca Alternifolia (Tea Tree)Leaf Oil , Water ,Glycerin , Allantoin,Allium Sativum (Garlic) Bulb Extract ,Cnidium Monnieri Fruit Extract ,Trimethoxysilylpropyl Steardimonium Chloride

Keep Out of Reach of Children

■If product gets into eyes, flush with water for 15 minutes

■If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration Section

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


Structured Label Content

Use

Proven effective in the treatment of most athlete’s foot (tinea pedis)and ringworm(tinea corporis).

Section 51945-4 (51945-4)

Purpose

Anti-fungal

Stop Use

If discomfort persists.

Warnings

For external use only

Ask Doctor

before you use If you have diabetes or poor blood circulation.

Do Not Use (Do not use)

■On irritated skin and any area that is infected or reddened.

■If pregnant or if there is any allergic reaction to this product.

When Using

avoid contact witheyes

Active Ingredients (Active ingredients)

Tolnaftate 1%

Inactive Ingredients (Inactive ingredients)

Melaleuca Alternifolia (Tea Tree)Leaf Oil , Water ,Glycerin , Allantoin,Allium Sativum (Garlic) Bulb Extract ,Cnidium Monnieri Fruit Extract ,Trimethoxysilylpropyl Steardimonium Chloride

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

■If product gets into eyes, flush with water for 15 minutes

■If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

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


Advanced Ingredient Data


Raw Label Data

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