215d92d5-7a5d-792b-e063-6394a90af6e6

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
Purpose

Anti-fungal

Description

Tolnaftate 1%

Medication Information

Warnings

For external use only

Purpose

Anti-fungal

Inactive Ingredients

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

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.

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%

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

Warnings

For external use only

Purpose

Anti-fungal

Inactive Ingredients (Inactive ingredients)

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

Use

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

Section 51945-4 (51945-4)

Stop Use

If discomfort persists.

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%

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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:32.368416 · Updated: 2026-03-14T23:03:39.501835