Otc - Active Ingredient
Undecylenic Acid 25%
Toenail Fungus Treatment Liquid
FDA Label NDC 84763-018
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 Toenail Fungus Treatment (NDC 84763-018). 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
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 broken or severely irritated skin.
Do not use on children under 2 years of age except under the advice and supervision of a doctor.
Otc - When Using
When using this product,avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation occurs or if there is no improvement within 2 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
Clean and thoroughly dry the affected area.
Apply a thin layer to the affected toenail and surrounding skin twice daily, in the morning and evening.
Pay special attention to the spaces between the toes.
Wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
Use for 2 weeks, or as directed by a doctor.
Inactive Ingredient
Acetyl Hexapeptide-8
Allantoin
Aloe Yohjyu Matsu Ekisu
Bisabolol
Caprylic/Capric Triglyceride
Centella Asiatica Extract
Ethylhexyl Palmitate
Glycerin
Melaleuca Alternifolia (Tea Tree) Leaf Oil
Niacinamide
Origanum Vulgare Oil
Palmitoyl Tetrapeptide-7
Palmitoyl Tripeptide-1
Piper Methysticum Root Extract
Sodium Hyaluronate
Tocopherol
Package Label.Principal Display Panel
Label1 (Label)
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