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FUNGAL NAIL TREATMENT MAXIMUM STRENGTH Liquid
Fungal Nail Treatment Maximum Strength Liquid
FDA Label NDC 83767-501
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 Ruijiu Electronic Technology Co., Ltd. for the product Fungal Nail Treatment Maximum Strength Liquid (NDC 83767-501). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Tolnaftate 1%
Undecylenic Acid 25%
Otc - Purpose
Anti-fungal and Nail Renewal
Indications & Usage
Antifungal use on fingemails, toenails, and the immediately adjacent skin.
Prevents the recurence of most athlete's foot with daily use
For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling.
Warnings
For external use only.
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor
Otc - When Using
avoid contact with the eyes.
Otc - Stop Use
Imitation occurs
There is no improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
If accidental ingestion occurs, get medical help or contact a PoisonControl Center right away.
Dosage & Administration
Apply once daily, preferably at bedtime or at least eight hours beforewashing. Clean and thoroughly dry the affected area, then use theapplicator brush provided to cover all affected nails. Ensure that theapplication is evenly distrnbuted across the entire nail plate
Storage And Handling
Store at room temperature 15--30°C(59°-86°F)
Protect from freezing; if freezingoccurs, wamm to room temperature
Keep tightly closed when not in use
Inactive Ingredient
ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER
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