SPL v2
SPL
SPL Set ID 3f9c682a-f9e6-b11c-e063-6394a90a1dcd
Route
TOPICAL
Published
Effective Date 2025-09-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (25 mg)
Inactive Ingredients
Simmondsia Chinensis (jojoba) Seed Oil Cyclopentasiloxane Eugenia Caryophyllus (clove) Bud Oil Lavandula Angustifolia (lavender) Oil Helianthus Annuus (sunflower) Seed Oil Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2025-10-06 Until 2026-09-29

Description

Undecylenic Acid 25%


Medication Information

Warnings and Precautions

For external use only.For external use only Keep away from fire and flame

Indications and Usage

Apply the treatment to the affected area of the nails

Dosage and Administration

Twice each day,4 sprays (1ml)each time. 15 days supply

Description

Undecylenic Acid 25%

Section 50565-1

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

Section 50566-9

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7

1. Do not apply on other parts of the body

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

Section 50570-1

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines .Ask a doctor before use if you hace heart disease.

Section 51727-6

Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Cyclopentasiloxane, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil.

Section 51945-4

Section 55105-1

Nail treatment

Section 55106-9

Undecylenic Acid 25%


Structured Label Content

Indications and Usage (34067-9)

Apply the treatment to the affected area of the nails

Dosage and Administration (34068-7)

Twice each day,4 sprays (1ml)each time. 15 days supply

Warnings and Precautions (34071-1)

For external use only.For external use only Keep away from fire and flame

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Chest pain, rapid heart beat, faintness, or dizziness occurs sudden, unexplained weight gain occurs,your hands or feet swell.

Section 50567-7 (50567-7)

1. Do not apply on other parts of the body

2. Avoid contact with the eyes in case of accidental contact rinse eyes with large arnounts of cool tap water.

Section 50570-1 (50570-1)

You ae under 18 years of age, Do not use it on babies and children your scalp is red.inflamed.infected, irritated, or painful

You use other medicines .Ask a doctor before use if you hace heart disease.

Section 51727-6 (51727-6)

Aloe Vera Extract, Helianthus Annuus (Sunflower) Seed Oil, Cyclopentasiloxane, Prunus Armeniaca (Apricot) Kernel Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Eugenia Caryophyllus (Clove) Bud Oil, Lavandula Angustifolia (Lavender) Oil, Hakka Yu, Tocopherol, Origanum Vulgare Oil, Simmondsia Chinensis (Jojoba) Seed Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Nail treatment

Section 55106-9 (55106-9)

Undecylenic Acid 25%


Advanced Ingredient Data


Raw Label Data

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