Otc - Active Ingredient
Undecylenic Acid 25%
Fungal Nail Repair Pen Liquid
FDA Label NDC 84763-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Fungal Nail Repair Pen (NDC 84763-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Indications & Usage
Mainly used to control and reduce nail fungus issues, and improve discoloration, thickening,
layering brittleness, and ingrown nails
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor
Otc - When Using
Avoid contact with eyes
Otc - Stop Use
Stop use and consult a doctor if irritation occurs or if there is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
Ask a doctor before use if you are pregnant, have sensitive skin, or are using this product on a child.
Keep out of reach of children
Dosage & Administration
Read all warnings and directions carefully
Use only as directed
Wash the affected area and dry thoroughly.
Remove cap from pen
Twist the base of the pen, with the brush pointing downward, until the product dispenses.
Apply a thin layer 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 toes; wear well-fitting, ventilated shoes,and change shoes and socks at least once daily
Inactive Ingredient
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)
Package Label.Principal Display Panel
Label1 (Label)
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