Otc - Active Ingredient
TEA TREE OIL
Elaimei Fungal Nail Patches Patch
FDA Label NDC 83804-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Shandian Jingling Technology Co., Ltd. for the product Elaimei Fungal Nail Patches (NDC 83804-011). 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
Lofuanna Fungal Nail Patches offers a quick repair solution that works overnight in just 8 hours, Ourpatches are hypoallergenic and specifically designed to fight fungal infections by addressing the rootcause, strengthening brittle nails, and visibly reducing discoloration. The patches are easy to applyand will securely adhere to the nail.
Warnings
For external use only.
Otc - Do Not Use
Not recommended while pregnant or breastfeeding.
Otc - When Using
For external use only. Avoid contact with eves, mouth, mucous membranes and wounds. Discontinue use if an allergic reaction occurs. Not recommended while pregnant or breastfeeding.
Store in a cool dry place, away from direct sunlight. Keep out of reach of children and pets
Otc - Stop Use
Discontinue use if an allergic reaction occurs.
Discontinue use if irritation occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets
Dosage & Administration
Clean and dry the affected area before application. Remove the protective film and peel off the releasepaper from the patch. Place the sticky side of the patch directly onto the infected area of the nalil. Gentlyfold the sides of the patch around your toe or finger for secure adherence. Leave the patch on for 6-8hours, ideally overnight, to allow for effective treatment.
Inactive Ingredient
Polyester
WATER
Glycerin
Package Label.Principal Display Panel
Label (Label)
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