85308-002

85308-002
SPL v1
SPL
SPL Set ID 31dd1fb8-e661-eae8-e063-6394a90ab5e8
Route
TOPICAL
Published
Effective Date 2025-04-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-03

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25%

Use

For the effective treatment of nail fungus,discoloration, thickening, splitting,crumbling and brittleness.

Stop Use

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

Warnings

For external use only.

Do not use

● on children under 2 years of age unless directed by a doctor.

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

When using this product

●Possible

side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Keep out of reach of children.

If swallowed,get medical help or contacta Poison Control Center right away.

Questions
Ask Doctor

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

Directions

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 thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.

3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas.

4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.

Do Not Use

on children under 2 years of age unless directed by a doctor.

When Using

When using this product

●Possible

side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Active Ingredient

Undecylenic Acid 25%

Other Information

Preservation method

Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).

Inactive Ingredients

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.

Principal Display Panel

Keep Oot of Reach of Children

Keep out of reach of children.

If swallowed,get medical help or contacta Poison Control Center right away.


Structured Label Content

Use

For the effective treatment of nail fungus,discoloration, thickening, splitting,crumbling and brittleness.

Purpose

Antifungal

Stop Use

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

Warnings

For external use only.

Do not use

● on children under 2 years of age unless directed by a doctor.

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

When using this product

●Possible

side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Keep out of reach of children.

If swallowed,get medical help or contacta Poison Control Center right away.

Questions
Ask Doctor

Stop use and ask a doctor

●if irritation occurs or if there is no improvement within 4 weeks.

Directions

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 thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results file nails every 2-3 days.

3. Hold the bottle at an angle to pour 2-3 drops.Use the brush applicator to applythe solution on the affected areas.

4. For best results, use this product consistenthy for 3-6 months, as fungal nail infections require prolonged treatment. Visible improvements may appear in as little as 7 days, but complete healing takes longer.

Do Not Use (Do not use)

on children under 2 years of age unless directed by a doctor.

When Using

When using this product

●Possible

side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur.

Active Ingredient

Undecylenic Acid 25%

Other Information (Other information)

Preservation method

Store in a cool, shaded place away from direct sunlight. Store at room temperature between15-30°C(59-86°F).

Inactive Ingredients (Inactive ingredients)

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Keep out of reach of children.

If swallowed,get medical help or contacta Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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