Otc - Active Ingredient
25% Undecylenic Acid(Treatment)
Treatonic Nailtonic Repair Pens Gel
FDA Label NDC 85569-015
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 Nailtonic Repair Pens (NDC 85569-015). 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 - 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
Antifungal
Dosage & Administration
For the effective treatment of nail fungus, discoloration, thickening, splitting, crmbing, 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
Avoid contact with the eyes
Otc - Ask Doctor
- Irritation occurs.
- There is no improvement within 4 weeks.
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
- 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.
Other Safety Information
Store at 20-25°C(68-77°F)
Inactive Ingredient
Water, Euphorbia Hirta Whole, Glycerin, Hydracrylic Acid, Isopropyl Myristate,Tea Tree Oil, Pseudolarix Amabilis Bark, Resorcinol
Otc - Questions
Email: [email protected]
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