Active Ingredient
Undecylenic Acid 10%
Neomen Nail Repair Pen Liquid
FDA Label NDC 83887-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Changsha Beiliang E-commerce Co., Ltd for the product Neomen Nail Repair Pen (NDC 83887-006). 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 active ingredient, purpose, use, warnings, do not use, when using, stop use, ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Use
• Improves nail appearance.
• For the treatment of fungal infections such as Candida albicans and other fungi, helps relieve symptoms caused by nail fungus, including discoloration and brittleness.
Warnings
For external use only (for nail fungus/onychomycosis only).
This product is not a substitute for prescription medicine.
Do Not Use
• On damaged skin (cuts, abrasions, eczema, or sunburn).
• If you are allergic to any of the ingredients.
• If you are pregnant or breastfeeding.
When Using
Avoid contact with eyes.
Stop Use
You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).
Ask Doctor
You develop symptoms of an allergic reaction (such as itching, rash, swelling of lips, eyelids, or difficulty breathing).
Keep Oot Of Reach Of Children
Keep Oot Of Reach Of Children
Directions
Wash and dry nails before application. Remove the cap covering the brush.
Twist the end of the pen clockwise to dispense liquid onto the brush.
Using the brush, apply a thin layer of liquid onto the affected area.
Let the area dry, then reapply another thin layer. Do this two more times.
Repeat this process 3 times daily for 6-8 weeks, or until the infection is gone.
Other Information
Store at 20° to 25°C (68° to 77°F).
Inactive Ingredients
Deacetylation Chitin , Salicylic Acid , Angelica Dahurica Root
Questions
www.neomenstore.com
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