Otc - Active Ingredient
ACETIC ACID 17%
Fungal Nail Repair
FDA Label NDC 84445-001
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 Furuizhilian Keji Co., Ltd. for the product Fungal Nail Repair (NDC 84445-001). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Otc - Keep Out Of Reach Of Children
Keep out ofreach ofchildren
Indications & Usage
For all caused by nail fungus
nail discoloration
nail thickening
nail splitting
nail crumbling
Warnings
Flammable, keep away from fire and flames
For external use only
Dosage & Administration
Apply it in the day and night
Before using it for the first time, soak thediseased nail with warm water to soften it,use the nail file to polish the nail, make itthin visibly, and scrape off the dirt on thenail (be careful not to hurt the nail bed),then apply the liquid
After first use, every 2-3 days, use the nailfille to polish the surface of the diseasednail and then continue to use it
Storage And Handling
Store at 59-86 °F(15-30°C)
Inactive Ingredient
Water, Alcohol, Phryma Leptostachya Extract,Salicylic Acid, Sophora Flavescens RootExtract, Garden Balsam (Impatiens Balsamina)Leaf Extract
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