Otc - Active Ingredient
Glacial Acetic Acid 10.5% w/wFor the removal of fungal nails.
Fungal Nail Treatment Liquid
FDA Label NDC 87083-020
7 label sections · Submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guchutang Biotechnology (longyan) Co., Ltd for the product Fungal Nail Treatment (NDC 87083-020). 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, otc - keep out of reach of children, warnings, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Use: This product is suitable for treating fungal infections of the fingernails or toenails (onychomycosis, commonly known as fungal nails) caused by dermatophytes, yeasts, and other fungi.
Otc - Keep Out Of Reach Of Children
Keep this product out of reach of children to prevent accidental ingestion. If swallowed, seek immediate medical help or contact a Poison Control Center.
Warnings
Warnings For external use only. Do not take by mouth. Avoid contact with eyes, oral mucosa, and other sensitive areas.
Dosage & Administration
Apply evenly to the entire surface of the affected nail and the inner nail edge (the junction between the nail plate and the skin). Use 1 to 2 times daily. The application frequency may be adjusted appropriately according to individual conditions.
Indications & Usage
Do not use if you are allergic to any ingredient in this product. Pregnant or breastfeeding women should use only under the guidance of a doctor. The safety and effectiveness for children have not been established; use under a doctor's guidance is required.
Inactive Ingredient
Inactive Ingredients: Ethanol, Glycerin, Purified Water.
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