Otc - Active Ingredient
TERBINAFINE HYDROCHLORIDE 1%
UNDECYLENIC ACID 25%
Antifungal Pen Liquid
FDA Label NDC 87571-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hanyang Qisheng (shenzhen) Technology Co., Ltd. for the product Antifungal Pen (NDC 87571-001). 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, 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
For the effective treatment of nail fungus,discoloration, thickening,splitting,crumbling and brittleness.
Warnings
For externaluse only.
Otc - Do Not Use
Do not use children under 2years 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,discontinue use and consulta doctor.
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
Use twice a day for 4 weeks.
For initial use, soak the affected nail in warm water to soften it. Gentlyf ile thenail to make it thinner and remove dirt, being cautious not to harm the nail bed.For best results f ile nails every 2-3 days.
Rotate clockwise, after the solution f lows out,apply the solution to the affected area.
Inactive Ingredient
ETHYLHEXYL PALMITATE
SQUALANE
CAPRYLIC/CAPRIC TRIGLYCERIDE
BISABOLOL
TOCOPHEROL
TEA TREE OIL
Package Label.Principal Display Panel
Label (Label)
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