FDA Label for Fungal Nail Nighttime Renewal Patches
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- DOSAGE & ADMINISTRATION
- WARNINGS
- OTC - DO NOT USE
- OTC - WHEN USING
- OTC - ASK DOCTOR
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Fungal Nail Nighttime Renewal Patches Product Label
The following document was submitted to the FDA by the labeler of this product 100 Karma Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Tolnaftate 1%
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
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