85150-002

85150-002
SPL v1
SPL
SPL Set ID 2ba241cc-2767-1190-e063-6294a90ac66b
Route
TOPICAL
Published
Effective Date 2025-01-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (10 g)
Inactive Ingredients
Microcrystalline Wax Almond Oil Bergamot Oil Mentha Arvensis Leaf Simmondsia Chinensis (jojoba) Seed Oil Petrolatum Beeswax Camphor (synthetic) Ceresin Salicylic Acid Tea Tree Oil Lavender Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-14

Description

Undecylenic Acid 10%

Purpose

Anti fungal


Medication Information

Purpose

Anti fungal

Description

Undecylenic Acid 10%

Use

1 Proven clinically effective in the treatment of most jock itch, ringworm, eczema, and athlete's foot.

2 For effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Stop Use

irritation occurs or a condition persists

Warnings

For external use only.

Ask Doctor

there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Directions

• clean the affected area and dry thoroughly

• apply a thin layer of the product over affected area twice daily or as directed by doctor

• supervise children in the use of this product

• for athlete's foot, pay special attention to the spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily

• for jock itch, use daily for 2 weeks

• not effective on the scalp or nails

Do Not Use

Children less than 2 years of age unless directed by a doctor.

When Using

• Avoid contact with eyes.

• Do not exceed recommended dose.

Active Ingredient

Undecylenic Acid 10%

Other Information

store at room temperature and out of direct sunlight.

Inactive Ingredients

Tea Tree Oil, Lavender Oil, Petrolatum, Mineral Oil.Microcrystalline Wax, Beeswax, Ceresin, Hydrogenated Sweet Almond Oil, Salicylic Acid, Melaleuca Alternifolia, Hakka Yu.Camphor, Bergamot Fruit Oil

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

1 Proven clinically effective in the treatment of most jock itch, ringworm, eczema, and athlete's foot.

2 For effective relief of itching, scaling, burning and discomfort that can accompany these conditions.

Purpose

Anti fungal

Stop Use

irritation occurs or a condition persists

Warnings

For external use only.

Ask Doctor

there is no improvement of athlete's foot or ringworm within 4 weeks or jock itch within 2 weeks.

Directions

• clean the affected area and dry thoroughly

• apply a thin layer of the product over affected area twice daily or as directed by doctor

• supervise children in the use of this product

• for athlete's foot, pay special attention to the spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily

• for jock itch, use daily for 2 weeks

• not effective on the scalp or nails

Do Not Use (Do not use)

Children less than 2 years of age unless directed by a doctor.

When Using

• Avoid contact with eyes.

• Do not exceed recommended dose.

Active Ingredient

Undecylenic Acid 10%

Other Information (Other information)

store at room temperature and out of direct sunlight.

Inactive Ingredients (Inactive ingredients)

Tea Tree Oil, Lavender Oil, Petrolatum, Mineral Oil.Microcrystalline Wax, Beeswax, Ceresin, Hydrogenated Sweet Almond Oil, Salicylic Acid, Melaleuca Alternifolia, Hakka Yu.Camphor, Bergamot Fruit Oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot 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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