Otc - Active Ingredient
Tolnaftate 1%
Fungal Nail Nighttime Renewal Patches Patch
FDA Label NDC 85569-009
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 100 Karma Inc for the product Fungal Nail Nighttime Renewal Patches (NDC 85569-009). 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, dosage & administration, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Antifungal
Dosage & Administration
- Helps inhibit the growth of fungus.
- lmproves the appearance of nails affected by fungus,including discoloration,thickening, splitting, crumbing, and brittleness.
Warnings
For external use only
Otc - Do Not Use
on children under 2 years ofage unless directed by a doctor on diaper rash
Otc - When Using
Avoid contact with eyes. do not exceed the recommended daly dosage unless directed by a doctor.
Otc - Ask Doctor
- mirritation occurs.
- there is no improvement within 4 weeks.
Otc - Pregnancy Or Breast Feeding
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
in case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Indications & Usage
▪ Clean & prepare the affected nail.
▪ Apply the antifungal solution to the affected nail.
▪ Apply the fungus nail patch. Firmly secure the patch to the sides of the toes or fingers, folding the remaining adhesive part to fully cover the toes/fingertips.
▪ Leave the patch on for 6–8 hours. Frequency: Use the patches consistently before bed.
▪ Maintain good foot hygiene.
Other Safety Information
store at 20-25°C (68-77°F)
Inactive Ingredient
Water, Glycerin, Sodium Carboxymethy Cellulose, Butylene clycol, Urea
Otc - Questions
Email: [email protected]
Package Label.Principal Display Panel
Patch (Patch)
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