84763-008 Nail Repair Pen

84763-008 Nail Repair Pen
SPL v1
SPL
SPL Set ID 45814b84-0e51-6c9d-e063-6394a90a2905
Route
TOPICAL
Published
Effective Date 2025-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (0.25 g)
Inactive Ingredients
Lavender Oil Aloe Vera Leaf Olive Oil White Pine Oil .alpha.-tocopherol Acetate Propolis Wax Borage Seed Oil Jojoba Oil Leptospermum Petersonii Leaf Oil Almond Oil Manuka Oil Clove Oil Oregano Leaf Oil Peppermint Oil Linseed Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-09

Description

Undecylenic Acid 25%


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

Mainly used to control and reduce nail fungus issues, and improve discoloration, thickening, layering, cracking

brittleness, and ingrown nails.

Dosage and Administration



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 laver 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-ftting, ventilated shoe. and change shoes and socks at least once daily.

Description

Undecylenic Acid 25%

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor lf irritation occurs or if there is no improvement within 2 weeks.

Section 50567-7

When using this product avoid contact with eyes.

Pregnant women, people with sensitive skin, or children should consult a professional before use.

Section 50570-1

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

Section 51727-6

Aloe Vera Extract

Sweet Almond Oil

Jojoba Oil

Tea Tree Oil

Manuka Oil

Clove Bud Oil

Lavender Oil

Oregano Oil

Peppermint Oil

Pine Oil

Olive Fruit Oil

Flaxseed Oil

Borage Seed Oil

Leptospermum Petersonii Leaf Oil

Propolis Extract

Tocopheryl Acetate (Vitamin E)

Section 51945-4

Section 55105-1

Antifungal

Section 55106-9

Undecylenic Acid 25%


Structured Label Content

Indications and Usage (34067-9)

Mainly used to control and reduce nail fungus issues, and improve discoloration, thickening, layering, cracking

brittleness, and ingrown nails.

Dosage and Administration (34068-7)



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 laver 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-ftting, ventilated shoe. and change shoes and socks at least once daily.

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor lf irritation occurs or if there is no improvement within 2 weeks.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes.

Pregnant women, people with sensitive skin, or children should consult a professional before use.

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Aloe Vera Extract

Sweet Almond Oil

Jojoba Oil

Tea Tree Oil

Manuka Oil

Clove Bud Oil

Lavender Oil

Oregano Oil

Peppermint Oil

Pine Oil

Olive Fruit Oil

Flaxseed Oil

Borage Seed Oil

Leptospermum Petersonii Leaf Oil

Propolis Extract

Tocopheryl Acetate (Vitamin E)

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Antifungal

Section 55106-9 (55106-9)

Undecylenic Acid 25%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)