85817-007

85817-007
SPL v1
SPL
SPL Set ID 413f6399-dda1-8dd9-e063-6394a90a573d
Route
TOPICAL
Published
Effective Date 2025-10-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-16

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25%

Use

Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

Stop Use

Stop use and ask a doctor If discomfort persists.​​

Warnings

For external use only.

Questions

Email at [email protected]

Ask Doctor

If you have diabetes or poor blood circulation.

Directions

Wash feet thoroughly with warm water, and gently file the thickened part of the fungal nail with a nail file until it's flat.

Apply a layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail.

Repeat the process twice a day. Use it continuously for at least 4 weeks to see the effect. And if you want complete improvement, we recommend using it for 6 weeks or more.

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 with eyes.

Active Ingredient

Undecylenic Acid 25%

Other Information

Store at room temperature and out of direct sunlight.

Skin discoloration may occur during or after use.

Inactive Ingredients

Mineral oil, Apricot Kernel Oil, Tea Tree Oil, Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil.

Principal Display Panel

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.


Structured Label Content

Use

Hinder fungal and bacterial growth, reduce itching, cleanse skin tissue.

Purpose

Antifungal

Stop Use

Stop use and ask a doctor If discomfort persists.​​

Warnings

For external use only.

Questions

Email at [email protected]

Ask Doctor

If you have diabetes or poor blood circulation.

Directions

Wash feet thoroughly with warm water, and gently file the thickened part of the fungal nail with a nail file until it's flat.

Apply a layer of the liquid to the surface of the fungal nail and allow it to be absorbed into the nail.

Repeat the process twice a day. Use it continuously for at least 4 weeks to see the effect. And if you want complete improvement, we recommend using it for 6 weeks or more.

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 with eyes.

Active Ingredient

Undecylenic Acid 25%

Other Information (Other information)

Store at room temperature and out of direct sunlight.

Skin discoloration may occur during or after use.

Inactive Ingredients (Inactive ingredients)

Mineral oil, Apricot Kernel Oil, Tea Tree Oil, Tocopherol, Peppermint Oil, Camphor Oil, Jojoba Oil, Bergamot Oil, Lavender Oil.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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.


Advanced Ingredient Data


Raw Label Data

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