SPL v1
SPL
SPL Set ID 9c823e27-8bb3-4ccd-bf7e-a99d45908e88
Route
TOPICAL
Published
Effective Date 2025-04-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 g)
Inactive Ingredients
Aloe Vera Leaf Canola Oil Clove Oil Lavender Oil Jojoba Oil Manuka Oil Oregano Leaf Oil Peppermint Oil Propolis Wax Almond Oil Tea Tree Oil .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-26

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25%

Uses 

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only.

Directions

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautios not to harm the nail bed. For best results file nails every 2-3 days.

3. Use the Nail Repair pen brush to apply the solution on the affected areas.

4. Visible results will be seen in as little as 7 days, continue regular usage to prevent fungus regrowth.

Do Not Use
  •  on children under 2 years of age unless directed by a doctor.
Ndc 83691 011 02

Active Ingredient

Undecylenic Acid 25%

Ndc 83691 011 01

Inactive Ingredients

Aloe Vera Extract, Canola Oil, Clove bud oil, Lavender oil, Jojoba Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond oil, Tea tree oil, Tocopheryl Acetate (Vitamin E)

When Using This Product
  • avoid contact with eyes.
Stop Use and Ask A Doctor If
  •  irritation occurs or there is no improvement within 4 weeks.

Structured Label Content

Uses 

For the Effective treatment of nail fungus, discoloration, thickening, splitting, crumbling and britteleness 

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antifungal

Warnings

For external use only.

Directions

1. Apply the product twice a day, in the morning and at night.

2. For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove dirt, being cautios not to harm the nail bed. For best results file nails every 2-3 days.

3. Use the Nail Repair pen brush to apply the solution on the affected areas.

4. Visible results will be seen in as little as 7 days, continue regular usage to prevent fungus regrowth.

Do Not Use (Do not use)
  •  on children under 2 years of age unless directed by a doctor.
Ndc 83691 011 02 (NDC 83691-011-02)

Active Ingredient (Active ingredient)

Undecylenic Acid 25%

Ndc 83691 011 01 (NDC 83691-011-01)

Inactive Ingredients

Aloe Vera Extract, Canola Oil, Clove bud oil, Lavender oil, Jojoba Oil, Manuka Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Sweet Almond oil, Tea tree oil, Tocopheryl Acetate (Vitamin E)

When Using This Product (When using this product)
  • avoid contact with eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  •  irritation occurs or there is no improvement within 4 weeks.

Advanced Ingredient Data


Raw Label Data

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