85817-008

85817-008
SPL v1
SPL
SPL Set ID 435c7973-8a67-8f51-e063-6394a90af58f
Route
TOPICAL
Published
Effective Date 2025-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (20 g)
Inactive Ingredients
Lavandula Angustifolia (lavender) Oil Ethylene .alpha.-tocopherol Acetate Dihydrophytosteryl Octyldecanoate Melaleuca Alternifolia (tea Tree) Leaf Oil Simmondsia Chinensis (jojoba) Seed Oil Mineral Oil Butyrospermum Parkii (shea) Butter Commiphora Myrrha Oil Chrysanthellum Indicum Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-12

Description

Undecylenic Acid 20%

Purpose

Anti-Fungal


Medication Information

Purpose

Anti-Fungal

Description

Undecylenic Acid 20%

Use

For the treatment of most athlete’s foot (tinea pedis)

For the treatment of ringworm (tinea corporis)

Helps prevent recurrence of these fungal infections

Stop Use

If you have diabetes or poor blood circulation

Warnings

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 condition persists.

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

Ask Doctor

If discomfort persists.

Directions

Clean the affected area and dry thoroughly.

Apply a thin layer over affected area twice daily (morning and night).

Use daily for 4 weeks; if condition persists, consult a doctor.

Do Not Use

On irritated skin and any area that is infected or reddened.

If pregnant or if there is any allergic reaction to this product.

When Using

Avoid contact with eyes.

Active Ingredient

Undecylenic Acid 20%

Other Information

Skin discoloration may occur during or after use. Protect from excessive heat (above 40°C / 104°F)

Inactive Ingredients

Mineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel

Keep Out of Reach of Children

If product gets into eyes, flush with water for 15 minutes

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


Structured Label Content

Use

For the treatment of most athlete’s foot (tinea pedis)

For the treatment of ringworm (tinea corporis)

Helps prevent recurrence of these fungal infections

Purpose

Anti-Fungal

Stop Use

If you have diabetes or poor blood circulation

Warnings

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 condition persists.

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

Ask Doctor

If discomfort persists.

Directions

Clean the affected area and dry thoroughly.

Apply a thin layer over affected area twice daily (morning and night).

Use daily for 4 weeks; if condition persists, consult a doctor.

Do Not Use (Do not use)

On irritated skin and any area that is infected or reddened.

If pregnant or if there is any allergic reaction to this product.

When Using

Avoid contact with eyes.

Active Ingredient

Undecylenic Acid 20%

Other Information (Other information)

Skin discoloration may occur during or after use. Protect from excessive heat (above 40°C / 104°F)

Inactive Ingredients (Inactive ingredients)

Mineral Oil, Ethylene/Propylene/Styrene Copolymer, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopheryl Acetate, Simmondsia Chinensis (Jojoba) Seed Oil, Butyrospermum Parkii (Shea) Butter, Commiphora Myrrha Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Lavandula Angustifolia (Lavender) Oil.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

If product gets into eyes, flush with water for 15 minutes

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


Advanced Ingredient Data


Raw Label Data

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