85834-001

85834-001
SPL v1
SPL
SPL Set ID 38c2639f-43db-d05c-e063-6394a90a0bc8
Route
TOPICAL
Published
Effective Date 2025-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Glycerin Euphorbia Hirta Whole Hydracrylic Acid Pseudolarix Amabilis Bark Resorcinol Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-30

Description

Tolnaftate 1%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Tolnaftate 1%

Use

For the effective treatment of nailfungus, discoloration, thickening,splitting, crumbling, and brittleness.

Stop Use

If irritation occurs. If an allergic reaction occurs.

Warnings

Avoid contact with eyes, mouth, andopen wounds. Rinse immediately ifexposed.If irritation persists, seekmedical help.keep out of reach ofchildren and pets.

Questions
Ask Doctor

if you are pregnant or breastfeeding.

if you have diabetes.

Directions

Soak the affected nail inwarm water to soften it. Gently file thenail to thin it and remove dirt, beingcautious not to harm the nail bed.

Application: Apply full layers of thesolution with the brush onto affectedareas on, around, and under the nails.A light tingle or burn is normal for thefirst 10 minutes until absorbed.

Frequency: Use twice daily (morningand night). Visible results may appearin 6 weeks. Continue regular use toprevent regrowth.

Do Not Use

On damaged skin (cuts, abrasions,eczema, sunburn).

lfyou have diabetes or poor bloodcirculation.

When Using

Skin discoloration may occur during or after use.

Active Ingredient

Tolnaftate 1%

Other Information

Store between 15°C to 30'C(59'F to86°F). Avoid freezing and excessiveheat above 40°C (104°F).

Inactive Ingredients

Euphorbia hirta whole, Glycerin, Hydracrylic Acid, Pseudolarix amabilis bark, Resorcinol, Water

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Children should use under adult supervision.


Structured Label Content

Use

For the effective treatment of nailfungus, discoloration, thickening,splitting, crumbling, and brittleness.

Purpose

Antifungal

Stop Use

If irritation occurs. If an allergic reaction occurs.

Warnings

Avoid contact with eyes, mouth, andopen wounds. Rinse immediately ifexposed.If irritation persists, seekmedical help.keep out of reach ofchildren and pets.

Questions
Ask Doctor

if you are pregnant or breastfeeding.

if you have diabetes.

Directions

Soak the affected nail inwarm water to soften it. Gently file thenail to thin it and remove dirt, beingcautious not to harm the nail bed.

Application: Apply full layers of thesolution with the brush onto affectedareas on, around, and under the nails.A light tingle or burn is normal for thefirst 10 minutes until absorbed.

Frequency: Use twice daily (morningand night). Visible results may appearin 6 weeks. Continue regular use toprevent regrowth.

Do Not Use (Do not use)

On damaged skin (cuts, abrasions,eczema, sunburn).

lfyou have diabetes or poor bloodcirculation.

When Using

Skin discoloration may occur during or after use.

Active Ingredient

Tolnaftate 1%

Other Information (Other information)

Store between 15°C to 30'C(59'F to86°F). Avoid freezing and excessiveheat above 40°C (104°F).

Inactive Ingredients (Inactive ingredients)

Euphorbia hirta whole, Glycerin, Hydracrylic Acid, Pseudolarix amabilis bark, Resorcinol, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Children should use under adult supervision.


Advanced Ingredient Data


Raw Label Data

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