Otc - Active Ingredient
25% Undecylenic Acid (Treatment)
Tolnaftate 1% (Patch)
Treatonic Tonenail Fungus Treatonic Kit. Kit
FDA Label NDC 85569-016
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 Treatonic Tonenail Fungus Treatonic Kit. (NDC 85569-016). 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.
Improves the appearance of nails affected by fungus, including discoloration, thickening,splitting, crumbing, and brittleness.
Warnings
For external use only
Otc - Do Not Use
- on childrenunder 2 years of age unless directed by a doctor
- on diaper rash
Otc - When Using
Avoid contact with eyes. Do not exceed the recommended daily dosage unless directed bya doctor.
Otc - Ask Doctor
- Irritation 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 PoisonControl Center right away.
Indications & Usage
Directions (Treatment)
- Wash affected area and dry thoroughly.
- Apply a thin layer of the product over the affected area(around the nails and underneath nail tips) twice daily or directed by a doctor.
- Supervise children in the use of this product.
- Clean & prepare the affected nail.
- Apply the antifungal solution to the affected nall.
- Apply the fungusnail 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.
Directions (Patch)
Other Safety Information
Store at 20-25°C (68-77°F)
Inactive Ingredient
Inactive ingredients (Treatment): Isopropyl Myristate, Tea Tree Oil
Inactive ingredients (Patch): Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea
Otc - Questions
Email: [email protected]
Package Label.Principal Display Panel
Package (Package)
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