Antfungal Pen-undecylenic Acid 25%

Antfungal Pen-undecylenic Acid 25%
SPL v1
SPL
SPL Set ID a15d4512-0fc6-424f-9dd3-ab433d9b7a26
Route
TOPICAL
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-28

Description

Undecylenic Acid 25%

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Undecylenic Acid 25%

Uses

For the treatment of athlete's foot, jock itch, and ringworm.

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product avoid contact with eyes.

Section 50570-1

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

Warnings

For external use only.

Directions

■ Read all warnings and directions

■ Use only as directed

■ Clean the affected area with soap and water and dry thoroughly

■ Remove cap from pen

■ Twist the base of the pen, with brush pointing downward, until product dispenses

■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Ndc 85210 001

Active Ingredient

Undecylenic Acid 25%

Other Information

■ Store at 15°-30°C (59° - 86°F)

■ Keep cap on pen when not in use

Inactive Ingredients

Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).

Ndc 85210 001 02 (03 Pens 9 Ml)

Ndc 85210 001 03 (06 Pens 18 Ml)


Structured Label Content

Uses

For the treatment of athlete's foot, jock itch, and ringworm.

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Section 50570-1 (50570-1)

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

Purpose

Antifungal

Warnings

For external use only.

Directions

■ Read all warnings and directions

■ Use only as directed

■ Clean the affected area with soap and water and dry thoroughly

■ Remove cap from pen

■ Twist the base of the pen, with brush pointing downward, until product dispenses

■ Apply a thin layer of the product over the affected area twice daily (morning and night) or as directed by a doctor

■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.

Ndc 85210 001 (NDC 85210-001)

Active Ingredient (Active ingredient)

Undecylenic Acid 25%

Other Information (Other information)

■ Store at 15°-30°C (59° - 86°F)

■ Keep cap on pen when not in use

Inactive Ingredients

Aloe Vera Extract, Sweet Almond Oil, Jojoba Oil, Tea Tree Oil, Manuka Oil, Clove Bud Oil, Lavender Oil, Oregano Oil, Peppermint Oil, Propolis Extract, Tocopheryl Acetate (Vitamin E).

Ndc 85210 001 02 (03 Pens 9 Ml) (NDC 85210-001-02 (03 Pens 9 mL))

Ndc 85210 001 03 (06 Pens 18 Ml) (NDC 85210-001-03 (06 Pens 18 mL))


Advanced Ingredient Data


Raw Label Data

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