Otc - Active Ingredient
25% Undecylenic Acid
1% Tolnaftate
Treatonic Toenail Fungus Treatment Kit
FDA Label NDC 85569-010
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 Toenail Fungus Treatment Kit (NDC 85569-010). 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 - 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
Anti-fungal
Indications & Usage
- 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 children under 2 years of age unless directed by a doctor.
- on diaper rash
Otc - When Using
when using this product:
avoid contact with eyes. Do not exceed the recommended daily dosge unless directed by a doctor.
Otc - Stop Use
Stop use and ask a doctor if
- irritation occurs
- this is no improvement within 4 weeks.
Otc - Pregnancy Or Breast Feeding
If pregnant 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.
Dosage & Administration
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 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.
Directions (Patch)
Other Safety Information
Store at 20-25°C (68-77°F)
Inactive Ingredient
(Treatment) Isopropyl Myristate, Tea Tree Oil
(Patch) Water, Glycerin, Sodium Carboxymethyl Cellulose, Butylene Glycol, Urea
Otc - Questions
Email: [email protected]
Package Label.Principal Display Panel
Kit (Kit)
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