Active Ingredient
Active ingredient: Undecylenic Acid 25%
Lakeim Fungal Nail Renewal Kit Liquid
FDA Label NDC 87408-009
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 Renewal Kit (NDC 87408-009). 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 out 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 Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Purpose
Antifungal
Stop Use
if irritation or symptoms worsen or last for more than 4 weeks.
When Using
• Do not apply to other parts of the body.
• Avoid making eye contact. In case of accidental eye contact, flush eyes with copious amounts of cold tap water.
• This product may not work for everyone.
Inactive Ingredients
Mineral oil, Apricot Kernel Oil, Tea Tree Oil,Tocopherol, Peppermint Oil, Lavender Oil
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 FUNGAL NAIL RENEWAL KIT
Net Contents: 2x15ml (0.5 fl.oz.) Bottles
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