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TOENAIL FUNGUS TREATMENT MAXIMUM STRENGTH Liquid
Toenail Fungus Treatment Maximum Strength Liquid
FDA Label NDC 84614-002
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 Ctrip Technology Co., Ltd. for the product Toenail Fungus Treatment Maximum Strength Liquid (NDC 84614-002). 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 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%
Otc - Purpose
Anti-fungal and Nail Renewal
Indications & Usage
Antifungal use on fingemails, toenails, and the immediately adjacent skin.
Fungal nails, Athlete's Foot, Tinea Manuum, Ringwomcaused byfungus and bacterial infection.
For all caused by nail fungus, nail discoloration, nail thickening,nailsplitting, nail crumbling
Warnings
Keep away from fire and flame.
Keep out of reach of children.
For use on nails and the immediately adjacent skin only.
Otc - Do Not Use
If a reaction suggesting sensitivity or iritation occurs.
Otc - When Using
Not for ophthalmic, oral, or intravaginal use
Otc - Stop Use
lf the area of application shows signs of increased iritation.
There is no improvement within 8 weeks.
When Pregnant or breast-feeding
Otc - Keep Out Of Reach Of Children
If accidental ingestion occurs, seek medical assistance or contact a Poison Control Center immediately.
Dosage & Administration
Use once daily, preferably before bedtimeUnscrew the cap and tilt the bottle to apply the medicine directly to thenail. The medication will then penetrate deeply into the nail.If the nail area is infected, spray the medication onto the affected toearea.
Storage And Handling
SHAKE WELL BEFORE USE
Store at room temperature 5--30°C(41°-86°F), Please store in a cool,dry place away from direct sunlight.
Keep tightly closed when not in use
Inactive Ingredient
UNDECYLENIC ACID
ALCOHOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
TOCOPHEROL
EDETATE DISODIUM
PHENOXYETHANOL
WATER
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Label (Label)
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