22ca0c1d-3f5c-8565-e063-6394a90a7115

SPL v1
SPL
SPL Set ID 22ca0c1d-3f5c-8565-e063-6394a90a7115
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

Purpose

Anti-fungal

Description

Tolnaftate 1%


Medication Information

Warnings

For external use only

Purpose

Anti-fungal

Inactive Ingredients

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

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)

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

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)