85817-009

85817-009
SPL v1
SPL
SPL Set ID 45f92be2-0677-5989-e063-6394a90af280
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Misoprostol (10 g)
Inactive Ingredients
Peppermint Oil Tea Tree Oil Apricot Kernel Oil Tocopherol Bergamot Oil Lavender Oil Jojoba Oil Camphor Oil Mineral Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

Description

Undecylenic acid 10%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic acid 10%

Use

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

Stop Use

■ Stop use and consult a doctor / health care professional if irritation or symptoms worsen.

Warnings

■ For external use only.

Questions
Ask Doctor

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

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 in the morning and evening for at least 8 weeks to see the effect. And if you want complete improvement, we recommend using it for 3-6 months.

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

Do Not Use

■ Do not use it if pregnant or on children under 2 years of age unless otherwise directed by a doctor.

When Using

■ When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic acid 10%

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

■ Keep out of reach of children.


Structured Label Content

Use

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

Purpose

Antifungal

Stop Use

■ Stop use and consult a doctor / health care professional if irritation or symptoms worsen.

Warnings

■ For external use only.

Questions
Ask Doctor

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

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 in the morning and evening for at least 8 weeks to see the effect. And if you want complete improvement, we recommend using it for 3-6 months.

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

Do Not Use (Do not use)

■ Do not use it if pregnant or on children under 2 years of age unless otherwise directed by a doctor.

When Using

■ When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic acid 10%

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)

■ Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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