SPL v1
SPL
SPL Set ID 215d92d5-7a5d-792b-e063-6394a90af6e6
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

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

Water,Glycerin, Allantoin, Alum Sativum (Garlic) Bulb Extact, Melaleuca Alternifolia (Tea Tree) Leaf Oil

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)

Water,Glycerin, Allantoin, Alum Sativum (Garlic) Bulb Extact, Melaleuca Alternifolia (Tea Tree) Leaf Oil

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

All Sections (JSON)