Active Ingredient
Active ingredient: Undecylenic Acid 25%
Lakeim Fungal Nail Repair Pen Liquid
FDA Label NDC 87408-007
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Jingliang Cosmetics Co., Ltd. for the product Lakeim Fungal Nail Repair Pen (NDC 87408-007). 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, ask doctor, do not use, keep oot of reach of children, purpose, stop use, when using, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Ask Doctor
if irritation or symptoms worsen or last for more than 4 weeks.
Do Not Use
• If you are pregnant or breastfeeding
• your skin is injured or cracked.
• you are under 18 years of age.
• irritation or discomfort occurs.
• you are using other medicines on your nails.
Keep Oot Of Reach Of Children
Store out of reach of children
Purpose
Antifungal
Stop Use
if irritation or symptoms worsen or last for more than 4 weeks.
When Using
Avoid making eye contact. In case of accidental eye contact, flush eyes with copious amounts of cold tap water.
Avoid applying to damaged skin to prevent potential discomfort or pain
Inactive Ingredients
Mineral Oil, Tea Tree Oil, Vitamin E, Jojoba Seed Oil, Shea Butter, Myrrh, Lavender Oil, Chrysanthellum Indicum Extract, Phytosteryl Oleate, Ethylene/Propylene/Styrene Copolymer
Directions
Wash your feet thoroughly with warm water.
Gently smooth the thickened nail surface using a nail file until even
Apply the nail treatment liquid evenly across the affected nail.
Make sure the treated area is fully dry before continuing
For best results, use the treatment twice daily morning and evening for at least 1 to 3 months
Since recovery time may differ depending on the severity of the fungal infection and individual conditions, consulting a specialist is recommended if needed
Warnings
For external application solely on fungal-affected nails, refrain from using on healthy nails
Avoid applying to damaged skin to prevent potential discomfort or pain
Store out of reach of children
Do not ingest and avoid contact with eyes.
In case of eye exposure, rinse thoroughly with water for 15 minutes
If ingested, seek immediate medical assistance or contact a Poison Control Center without delay.
Uses
Prevents fungal and bacterial infections.
Reduces itching and Cleanses the skin.
Package Label.Principal Display Panel
Product Name: Lakeim Nail Fungus Repair Pen
Net Contents:
4 ml/ pen
3 pens in 1 PACKAGE
* Please review the disclaimer below.
