Otc - Active Ingredient
UNDECYLENIC ACID 25%
Fungal Nail Treatment Liquid
FDA Label NDC 76986-031
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 Fungal Nail Treatment (NDC 76986-031). 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
Renew Nails
Indications & Usage
For the treatment of fungal infections of the nails Helps relieve itching, scaling, and discomfort associated with fungal infections
Warnings
For external use only.
Otc - Do Not Use
If you expenence any signs of sensitivity or imitation,discontinue use and consult a doctor
Otc - When Using
When using this product Avoid contact with eyes
Otc - Stop Use
Stop use and ask a doctor iflf discomfort persists
Otc - Keep Out Of Reach Of Children
if the product gets into your eyes, flush with water for 15 minutes.
if swallowed, get medical help or contact a Poison Control Center right away
Dosage & Administration
Use daily for at least 4 weeks or as directed by a doctor
Before use, clean the affected nail(s) and dry thoroughly.
Apply a thin layer of the product directly onto the affected nail, including the nail surface, edges, and cuticle area
Use twice daily (moming and evening)
Allow the solution to fully dry before covering the nail or wearing shoes/socks
For best results, continue use as directed
Supervise children in the use of this product.
This product is not intended for use on the scalpor skin other than around the nail
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
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Label (Label)
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