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SIDINOX TOENAIL FUNGUS TREATMENT Liquid
Sidinox Toenail Fungus Treatment Liquid
FDA Label NDC 83767-801
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Ruijiu Electronic Technology Co., Ltd. for the product Sidinox Toenail Fungus Treatment Liquid (NDC 83767-801). 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 - when using, otc - stop use, 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
Antifungal treatment for fingernails, toenails, and surrounding skin.Efective against fungal nails, athlete's fcot, tinea manuum,and ringworm caused by fungi.Addresses nail fungus, discoloralionthickening, splitling, and crumbling.
Warnings
Keep away from fire and flames.
Keep out of reach of children.
For external use on nails and the immediately adjacent skin only.
Otc - Do Not Use
Do not use ifyou experience any signs of sensitivity or irritation
Otc - When Using
While using this product:Not for use in the eyes, mouth, or vaginal area.
Otc - Stop Use
Stop use and consult a doctor if:
If the area of application shows increased irritation
If there is no improvement within 8 weeks.
If pregnant or breaslleeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children:
If accidental ingestion occurs, seek medical assistance or contact aPoison Control Center immediately.
Dosage & Administration
Use once daily, preferably before bedtime.
Unscrew the bottle cap and use the brush to apply the medicine directlyto the nail.The medication will then penetrate deeply into the nail.
If the nail area is infected, spray the medication onto the affected area.
Storage And Handling
SHAKE WELL BEFORE USE.
Store at 5'C to 30°0(41'F to 86°F) in a cool
dry place. Keep tighosedand away from sunlight.
Inactive Ingredient
ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
EDETATE DISODIUM
PHENOXYETHANOL
WATER
Package Label.Principal Display Panel
Label (111)
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