Otc - Active Ingredient
Terbinafine 1%
Toenail Fungus Treatment Liquid
FDA Label NDC 87413-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shenzhen Wankelai E-commerce Co., Ltd. for the product Toenail Fungus Treatment (NDC 87413-002). 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 external use only.
Otc - Do Not Use
If on children under 2 years of age unless directed by a doctor.
Otc - When Using
·Avoid contact with eyes.
Otc - Stop Use
Irritation occurs or if there is no improvement within 4 weeks.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Apply the product twice a day, in the morning and at night.
Soak nails in warm water to soften, then gently file affected nails.
Clean the affected area with soap and water and dry thoroughly.
Directly to affected nail
Allow a few minutes to dry after each.
Use daily for 4-6 weeks, depending on the condition of the area needing repair.
Inactive Ingredient
ALCOHOL,DIMETHICONE,CETOSTEARYL ALCOHOL,TEA TREE OIL,PROPYLENE GLYCOL,TOCOPHEROL,SAFFLOWER OIL,WATER
Package Label.Principal Display Panel
Label (Label)
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