Otc - Active Ingredient
Undecylenic Acid 25%
Nail Repair Pen Liquid
FDA Label NDC 84763-008
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 Nail Repair Pen (NDC 84763-008). 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, cracking
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
When using this product avoid contact with eyes.
Pregnant women, people with sensitive skin, or children should consult a professional before use.
Otc - Stop Use
Stop use and ask a doctor lf irritation occurs or if there is no improvement within 2 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & 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.
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
Label (Label)
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