Otc - Active Ingredient
UNDECYLENIC ACID 25%
Soothesense Toenail Fungus Treatment Liquid
FDA Label NDC 76986-027
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Soothesense Toenail Fungus Treatment (NDC 76986-027). 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 relief of itching, burningand irritation associated with these conditions
Helps in the treatment of antifungal infections on skin around nails
Warnings
For external use only.
Otc - Do Not Use
Do not use on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product, avoid contact with eyes. lf contact occurs rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor ifirritation occurs or 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
Clean and dry affected area
Apply a thin layer twice daily (morning and night).
Continue treatment for at least 4 weeks. For nail fungus, treatment may be required for 8-12 weeks
Inactive Ingredient
ALCOHOL
WATER
UREA
PROPYLENE GLYCOL
SALICYLIC ACID
MENTHOL
HYDROXYPROPYLCELLULOSE
ZANTHOXYLUM BUNGEANUM FRUIT EXTRACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL
DISODIUM EDTA
GLYCOLIC ACID
Package Label.Principal Display Panel
Label1 (Label1)
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