Otc - Active Ingredient
Tolnaftate1%
Undecylenic Acid 25%
Rdvhdlw Extra Strength Nail Repair Pen Liquid
FDA Label NDC 83766-001
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 Joyuflsh Technology Co.,ltd. for the product Rdvhdlw Extra Strength Nail Repair Pen (NDC 83766-001). 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
Anti-fungal and Nail Renewal
Indications & Usage
STRENGTH PENS: Targets foot fungus & discoloration, Fast-drying & easy application, For daily antifungal care.
REPAIR PENS: Hydrates dry, cracked skin, Soothes & restores rough feet,Improves overall foot appearance.
Warnings
For external use only.
Otc - Do Not Use
Children under 2 years of age.
Pregnant or if there is any allergic reaction to this produce.
Otc - When Using
Avoid contact with eyes. If in eyes, rinse thoroughly with water.
Otc - Stop Use
Irritation occurs or discomfort persists.
Otc - Keep Out Of Reach Of Children
If accidental ingestion occurs, seek medical attention immediately and contact a Poison Control Center.
Dosage & Administration
1.Wash and dry your nails thoroughly before applying the product. Remove the cap thatcovers the brush.
2.Press the button at the end of the pen to dispense the liquid onto the brush.
3.Apply the liquid three times to the areas requiring treatment, ensuring complete coverageof all affected parts.
4.Use 2-3 times daily for 2-4 weeks, depending on the condition being treated.
Inactive Ingredient
ALCOHOL
POLYETHYLENE GLYCOL
PROPYLENE GLYCOL
DIMETHICONE
C12-15 ALKYL LACTATE
ETHYLHEXYLGLYCERIN
GLYCERIN
LAUROCAPRAM
SOPHORA FLAVESCENS ROOT
TOCOPHEROL
PHENOXYETHANOL
WATER
Package Label.Principal Display Panel
Label1 (Label1)
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