85817-006

85817-006
SPL v1
SPL
SPL Set ID 413e76b5-263c-62fa-e063-6294a90a9214
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
Bergamot Oil Jojoba Oil Tocopherol Camphor Oil Peppermint Oil Lavender Oil Mineral Oil Apricot Kernel Oil Tea Tree 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

and consult a doctor / health care professional if

irritation or symptoms worsen.

Warnings

For external use only.

Questions

Visit : Arflom.com email to [email protected]

Directions

■ Before using it, clean the affected area with soap and soak the nail with warm water to soften it.

■ For toe fungus,

- scrape off the dirt on the nail, and gently file the thickened part of the fungal nail with a nail file until it's flat. (be careful not to hurt the nail bed)

-You can use a nail file every 2-3 days to polish the surface of the affected area.

-Apply the liquid with a thin layer over the affected area, the skin under the nail, and around the cuticle area.

■ For athlete's foot, pay special attention to spaces between toes.

■ Use it twice daily, in the morning and evening, for at least 6 weeks to see results. For complete improvement, we recommend using it for 3 to 6 months or longer.

■ You can use this product preventively for fungus in hot and humid conditions.

Do Not Use

■ if you are pregnant

■ if you are allergic to vinegar (such as itching, rash swelling of the lips, eyelids, and shortness of breath).

■ on children under 2 years of age unless otherwise 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 and out of direct sunlight.

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 swallowed, call a poison control centre or get medical help right away.


Structured Label Content

Use

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

Purpose

Antifungal

Stop Use

and consult a doctor / health care professional if

irritation or symptoms worsen.

Warnings

For external use only.

Questions

Visit : Arflom.com email to [email protected]

Directions

■ Before using it, clean the affected area with soap and soak the nail with warm water to soften it.

■ For toe fungus,

- scrape off the dirt on the nail, and gently file the thickened part of the fungal nail with a nail file until it's flat. (be careful not to hurt the nail bed)

-You can use a nail file every 2-3 days to polish the surface of the affected area.

-Apply the liquid with a thin layer over the affected area, the skin under the nail, and around the cuticle area.

■ For athlete's foot, pay special attention to spaces between toes.

■ Use it twice daily, in the morning and evening, for at least 6 weeks to see results. For complete improvement, we recommend using it for 3 to 6 months or longer.

■ You can use this product preventively for fungus in hot and humid conditions.

Do Not Use (Do not use)

■ if you are pregnant

■ if you are allergic to vinegar (such as itching, rash swelling of the lips, eyelids, and shortness of breath).

■ on children under 2 years of age unless otherwise 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 and out of direct sunlight.

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 swallowed, call a poison control centre or get medical help right away.


Advanced Ingredient Data


Raw Label Data

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