Active Ingredient
TEA TREE OIL 10X HPUS
Toenail Fungus / Nail Repair Pen
FDA Label NDC 82743-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vital Synergy Llc for the product Toenail Fungus / Nail Repair Pen (NDC 82743-101). 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, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
ANTIFUNGAL
Uses
STRONG NAILS FAST
YELLOW BROKEN BRITTLE TOENAILS & FINGERNAILS
Warnings
FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES. DISCONTINUE USE IF ADVERSE SKIN REACTION OCCURS. CONSULT YOUR HEALTH CARE PHYSICIAN IF PREGNANT, NURSING, OR FOR A CHILD UNDER THE AGE OF TWO.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Directions
TEST ON A SMALL PART OF A NAIL FIRST. APPLY TOPICALLY TWICE PER DAY ON THE AFFECTED AREA.
Inactive Ingredients
ALOE VERA EXTRACT, EUCALYPTUS OIL, LAVENDER OIL, SWEET ALMOND OIL, VITAMIN C, AND VITAMIN E
Package Label.Principal Display Panel
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