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Toenail Fungus Treatment Extra Strength Pen
Toenail Fungus Treatment Extra Strength Pen Liquid
FDA Label NDC 85038-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Lianjiang Shanlilai E-commerce Co., Ltd. for the product Toenail Fungus Treatment Extra Strength Pen (NDC 85038-001). 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 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
Indications & Usage
For the effective treatment of nail fungus,discoloration,thick-ening,splitting,crumbling and brittleness.
Warnings
For external use only.
Otc - Do Not Use
children under 2 years of age.
pregnant or if there is any allergic reaction to this produce.
Otc - When Using
Avoid contact with eyes. in case of contact, rinse thoroughly
with water.
Otc - Stop Use
lrritation occurs or discomfort persists.
Otc - Keep Out Of Reach Of Children
In case of accidental ingestion, seek medical advice
immediately or contact a Poison Control center right away.
Dosage & Administration
Wash and dry your nails before use, Remove the capcovering the brush of the pen.
Twist the end of the pen clockwise to dispense the liquidonto the brush.
Apply the liquid 3 times over the areas that need to berepalred, and make sure to cover all affected parts.
Use 2-3 times daily for 2-4 week s, depending on thecondition of the area that needs repair.
Storage And Handling
Store between 15° to 30 °C (59 °to 86 °F)Avoid freezing andexcessive heat above 40C°(104F).
Inactive Ingredient
ALCOHOL
DIMETHICONE
CETOSTEARYL ALCOHOL
TEA TREE OIL
PROPYLENE GLYCOL
TOCOPHEROL
SAFFLOWER OIL
WATER
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Label (Label)
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