83887-006

83887-006
SPL v1
SPL
SPL Set ID 3356b681-f499-7d0e-e063-6294a90adaf6
Route
TOPICAL
Published
Effective Date 2025-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Chitin Angelica Dahurica Root Salicylic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-22

Description

Undecylenic Acid 10%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 10%

Use

• Improves nail appearance.

• For the treatment of fungal infections such as Candida albicans and other fungi, helps relieve symptoms caused by nail fungus, including discoloration and brittleness.

Stop Use

You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).

Warnings

For external use only (for nail fungus/onychomycosis only).

This product is not a substitute for prescription medicine.

Questions

www.neomenstore.com

Ask Doctor

You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).

Directions

Wash and dry nails before application. Remove the cap covering the brush.

Twist the end of the pen clockwise to dispense liquid onto the brush.

Using the brush, apply a thin layer of liquid onto the affected area.

Let the area dry, then reapply another thin layer. Do this two more times.

Repeat this process 3 times daily for 6-8 weeks, or until the infection is gone.

Do Not Use

• On damaged skin (cuts, abrasions, eczema, or sunburn).

• If you are allergic to any of the ingredients.

• If you are pregnant or breastfeeding.

When Using

Avoid contact with eyes.

Active Ingredient

Undecylenic Acid 10%

Other Information

Store at 20° to 25°C (68° to 77°F).

Inactive Ingredients

Deacetylation Chitin , Salicylic Acid , Angelica Dahurica Root

Principal Display Panel

Keep Oot of Reach of Children

Keep Oot Of Reach Of Children


Structured Label Content

Use

• Improves nail appearance.

• For the treatment of fungal infections such as Candida albicans and other fungi, helps relieve symptoms caused by nail fungus, including discoloration and brittleness.

Purpose

Antifungal

Stop Use

You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).

Warnings

For external use only (for nail fungus/onychomycosis only).

This product is not a substitute for prescription medicine.

Questions

www.neomenstore.com

Ask Doctor

You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).

Directions

Wash and dry nails before application. Remove the cap covering the brush.

Twist the end of the pen clockwise to dispense liquid onto the brush.

Using the brush, apply a thin layer of liquid onto the affected area.

Let the area dry, then reapply another thin layer. Do this two more times.

Repeat this process 3 times daily for 6-8 weeks, or until the infection is gone.

Do Not Use (Do not use)

• On damaged skin (cuts, abrasions, eczema, or sunburn).

• If you are allergic to any of the ingredients.

• If you are pregnant or breastfeeding.

When Using

Avoid contact with eyes.

Active Ingredient

Undecylenic Acid 10%

Other Information (Other information)

Store at 20° to 25°C (68° to 77°F).

Inactive Ingredients (Inactive ingredients)

Deacetylation Chitin , Salicylic Acid , Angelica Dahurica Root

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

Keep Oot Of Reach Of Children


Advanced Ingredient Data


Raw Label Data

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