Otc - Active Ingredient
25% Undecylenic Acid
Toenail Fungus Treatment Liquid
FDA Label NDC 85569-005
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 Toenail Fungus Treatment (NDC 85569-005). 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
Antifungal
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
Do not use
- on children under 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 by a doctor.
Otc - Stop Use
Stop and ask a doctor if ▪ irritation occurs. ▪ there 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
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
▪ 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
Isopropyl Myristate, Tea Tree Oil
Otc - Questions
Email: [email protected]
Package Label.Principal Display Panel
Treatment (Liquid)
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