83818-019 Update Manufacturer

83818-019 Update Manufacturer
SPL v3
SPL
SPL Set ID 3a08ec6c-03ae-b9e5-e063-6394a90a0afb
Route
TOPICAL
Published
Effective Date 2025-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-16

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

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

Questions

Email us: [email protected]

Ask Doctor

if irritation, redness, or symptoms worsen or persist

Directions

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

■ For toenail fungus:

▸ Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed)

▸ Apply a thin layer over the entire nail surface, under the nail edge, and around the cuticle

■ Use twice daily-morning and evening for at least 6 weeks

■ For best results, continue use for 3-6 months or as directed by a doctor

■ For athlete's foot: Apply to affected areas and between toes

■ Allow product to dry fully before putting on socks or shoes

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

If swallowed, rinse mouth and seek medical attention or contact a Poison Control Center right away.


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

Antifungal

Stop Use

if irritation, redness, or symptoms worsen or persist

Warnings

For external use only

Questions

Email us: [email protected]

Ask Doctor

if irritation, redness, or symptoms worsen or persist

Directions

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

■ For toenail fungus:

▸ Gently file thickened areas of the nail every 2-3 days (avoid damaging nail bed)

▸ Apply a thin layer over the entire nail surface, under the nail edge, and around the cuticle

■ Use twice daily-morning and evening for at least 6 weeks

■ For best results, continue use for 3-6 months or as directed by a doctor

■ For athlete's foot: Apply to affected areas and between toes

■ Allow product to dry fully before putting on socks or shoes

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)

If swallowed, rinse mouth and seek medical attention or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)