76986-016

76986-016
SPL v1
SPL
SPL Set ID 44f5c1bc-decf-beef-e063-6394a90ab562
Route
topical
Published
Effective Date 2025-12-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
undecylenic acid (11 g)
Inactive Ingredients
melaleuca alternifolia (tea tree) leaf oil zanthoxylum bungeanum fruit salicylic acid alcohol water propylene glycol glycolic acid urea menthol hydroxypropylcellulose edetate disodium

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-12-02

Purpose

Antifungal

Description

Undecylenic Acid (11%)


Medication Information

Warnings



• For external use only.

Purpose

Antifungal

Directions

• Clean and dry affected area.

• Apply a thin layer twice daily (morning and night).

• Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8–12 weeks.

Other Information

•Store at 20°-25C(68°-77°F).

•Protect from light.

•Keep container tightly closed.

•See bottom of package for lot number and expiration date.

Inactive Ingredients

Alcohol,Water‌,‌Urea‌,Propylene Glycol,Salicylic Acid‌,‌Menthol‌ ,Hydroxypropylcellulose‌ ,‌Zanthoxylum Bungeanum Fruit Extract,Melaleuca Alternifolia (Tea Tree) Leaf Oil,‌Disodium EDTA‌,Glycolic Acid‌

Description

Undecylenic Acid (11%)

Principal Display Panel

Use

• For the relief of itching, burning, and irritation associated with these conditions.

• Helps in the treatment of antifungal infections on skin around nails.

Stop Use

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Questions

Tel.400-055-8876

Manufacturerd: Guangdong Quadrant Ecological Technology Co.,Ltd.

Address: Building B, General Plant, North Shanfen Road, West Songshan Road,Longhu,Shantou,Guangdong,China

Ask Doctor

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Do Not Use

• Do not use on children under 2 years of age unless directed by a doctor.

When Using

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic Acid (11%)

Keep Out of Reach of Children

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


Structured Label Content

Warnings



• For external use only.

Purpose

Antifungal

Directions

• Clean and dry affected area.

• Apply a thin layer twice daily (morning and night).

• Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8–12 weeks.

Other Information (Other information)

•Store at 20°-25C(68°-77°F).

•Protect from light.

•Keep container tightly closed.

•See bottom of package for lot number and expiration date.

Inactive Ingredients (Inactive ingredients)

Alcohol,Water‌,‌Urea‌,Propylene Glycol,Salicylic Acid‌,‌Menthol‌ ,Hydroxypropylcellulose‌ ,‌Zanthoxylum Bungeanum Fruit Extract,Melaleuca Alternifolia (Tea Tree) Leaf Oil,‌Disodium EDTA‌,Glycolic Acid‌

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Use

• For the relief of itching, burning, and irritation associated with these conditions.

• Helps in the treatment of antifungal infections on skin around nails.

Stop Use

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Questions

Tel.400-055-8876

Manufacturerd: Guangdong Quadrant Ecological Technology Co.,Ltd.

Address: Building B, General Plant, North Shanfen Road, West Songshan Road,Longhu,Shantou,Guangdong,China

Ask Doctor

• Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Do Not Use (Do not use)

• Do not use on children under 2 years of age unless directed by a doctor.

When Using

• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Active Ingredient

Undecylenic Acid (11%)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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