83818-026

83818-026
SPL v1
SPL
SPL Set ID 487d2e22-6328-893f-e063-6394a90a9dff
Route
TOPICAL
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Tocopherol Jojoba Oil Bergamot Oil Mineral Oil Peppermint Oil Camphor Oil Lavender Oil Apricot Kernel Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-16

Description

Undecylenic Acid 25%

Purpose

Toenail Fungus treatment


Medication Information

Purpose

Toenail Fungus treatment

Description

Undecylenic Acid 25%

Use

▪ Helps prevent fungal infections, including nail fungus and athlete's foot

▪ Helps reduce itching, burning, and discoloration

• Supports healthy nail and skin regeneration

▪ Helps cleanse and protect affected skin and nail surfaces

Stop Use

if irritation, redness, or symptoms worsen or persist

Warnings

For external use only

• Do not use on children under 2 years of age unless directed by a doctor

■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Purpose ....Antifungal

▪ Stop use and ask a doctor if irritation, redness, or symptoms worsen or persist

■ Keep out of reach of children

■ If swallowed, rinse mouth and seek medical attention or contact a Poison Control

Center right away.

Questions

email us at [email protected]

Ask Doctor

irritation, redness, or symptoms worsen or persist

Directions

Wash the affected area with soap and water. Soak the nail to soften it

Do Not Use

Do not use on children under 2 years of age unless directed by a doctor

When Using

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Active Ingredient

Undecylenic Acid 25%

Other Information

Store at room temperature (59°-86°F/15°-30°C)

▪ Keep away from direct sunlight and excessive moisture

Close cap tightly after each use

Inactive Ingredients

Apricot Kernel Oil, Bergamot Oil, Camphor Oil, Jojoba Oil, Lavender Oil, Mineral Oil, Peppermint Oil, Tea Tree Oil, Tocopherol (Vitamin E)

Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Use

▪ Helps prevent fungal infections, including nail fungus and athlete's foot

▪ Helps reduce itching, burning, and discoloration

• Supports healthy nail and skin regeneration

▪ Helps cleanse and protect affected skin and nail surfaces

Purpose

Toenail Fungus treatment

Stop Use

if irritation, redness, or symptoms worsen or persist

Warnings

For external use only

• Do not use on children under 2 years of age unless directed by a doctor

■ Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Purpose ....Antifungal

▪ Stop use and ask a doctor if irritation, redness, or symptoms worsen or persist

■ Keep out of reach of children

■ If swallowed, rinse mouth and seek medical attention or contact a Poison Control

Center right away.

Questions

email us at [email protected]

Ask Doctor

irritation, redness, or symptoms worsen or persist

Directions

Wash the affected area with soap and water. Soak the nail to soften it

Do Not Use (Do not use)

Do not use on children under 2 years of age unless directed by a doctor

When Using

Avoid contact with eyes. If contact occurs, rinse thoroughly with water

Active Ingredient

Undecylenic Acid 25%

Other Information (Other information)

Store at room temperature (59°-86°F/15°-30°C)

▪ Keep away from direct sunlight and excessive moisture

Close cap tightly after each use

Inactive Ingredients (Inactive ingredients)

Apricot Kernel Oil, Bergamot Oil, Camphor Oil, Jojoba Oil, Lavender Oil, Mineral Oil, Peppermint Oil, Tea Tree Oil, Tocopherol (Vitamin E)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)