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Fungal Nail Patches
Fungal Nail Patches Patch
FDA Label NDC 85038-005
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 Fungal Nail Patches (NDC 85038-005). 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 - 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 - Active Ingredient
TOLNAFTATE 1%
UNDECYLENIC ACID 25%
Otc - Purpose
Anti-fungal
Indications & Usage
Repairs fungal nail damage and improves nail appearance.
Warnings
For external use only.
Otc - Do Not Use
Do not use on any skin with inflammation,infectlon, or redness.
Do not use if preqnant or if there is an allergic reaction to this product
Avoid contact with eyes.
Otc - Stop Use
Stop use and ask a doctor if lrritation occurs or discomfort persists
Otc - Keep Out Of Reach Of Children
in case of accidental ingestion, seek medical advice immediatelyor contact a Poison Control Center right away
Dosage & Administration
Clean and prepare the affected nail.
Apply the fungal nail patch. Firmly secure the patch tothe sides of the toes or fingers, folding the remainingadhesive part to fully cover the toesffingertips.
Leave the patch on for 6 -8 hours. Use the patchesconsistently before bed for 3 -é months.
Maintain good foot hygiene.
Storage And Handling
Store at room temperature and avoid excessive heat and direct sunlight.
Inactive Ingredient
Polyester Spandex
Acrylate Copolymer
Tackifying Resin
Glycerin
Water
Silicone Oil Paper
Package Label.Principal Display Panel
Label1 (Label1)
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