Otc - Active Ingredient
Undecylenic Acid 25%
Tolnaftate 1%
Antifungal Nail Solution Liquid
FDA Label NDC 84763-019
11 label sections · Submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yunqi Cosmetics (shenzhen) Co., Ltd for the product Antifungal Nail Solution (NDC 84763-019). 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
Anti fungal
Indications & Usage
Helps improve the appearance of toenails affected by fungal infection,including discoloration, thickening,splitting, crumbling, and brittleness.
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product, avoid contact with the eyes.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if there is no improvement within 6 weeks.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
1.Apply the product twice a day, in the morning and at night.
2.For initial use, soak the affected nail in warm water to soften it. Gently file the nail to make it thinner and remove debris, being cautious not to harm the nail bed. For best results,file nails every 2-3 days.
3.Dropper prevents re-dipping a brush and contaminating the bottle;squeeze the dropper 1-3 times onto a cotton swab, then apply to the affected area.
4.Visible results will be seen in as littleas 4 weeks, continue regular usage to prevent fungus regrowth.
Inactive Ingredient
Caprylic/Capric Triglyceride
Ethylhexyl Palmitate
Glycerin
Niacinamide
Tocopherol
Allantoin
Sodium Hyaluronate
Palmitoyl Tetrapeptide-7
Acetyl Hexapeptide-8
Palmitoyl Tripeptide-1
Origanum Vulgare Oil
Aloe Yohjyu Matsu Ekisu
Piper Methysticum Root Extract
Centella Asiatica Extract
Sophora Flavescens Root Extract
Propolis Extract
Package Label.Principal Display Panel
Label (Label)
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