Otc - Active Ingredient
Undecylenic Acid 25%
Treatonic Antifungal Pen Gel
FDA Label NDC 85569-017
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 Antifungal Pen (NDC 85569-017). 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 - keep out of reach of children, indications & usage, other safety information, inactive ingredient, 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 treatment of most athlete's foot(tinea pedis), jock itch(tinea cruris) and ringworm(tinea corporis).
- For effective relief of itching, cracking and burning skin.
Warnings
For external use only
Do not use
on children under 2 years of age unless directed by a doctor.
When using this product
avoid contact with the eyes
Stop and ask a doctor if
irritation occurs or if there isno improvement within 4 weeks
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
- Clean the affected area and dry thoroughly.
- Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor.
- Supervise children in the use of this product.
- For athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily.
- For athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks.If condition persists longer,consult a doctor. This product is not effective on the scalp or nails.
Other Safety Information
store at room temperature.
Inactive Ingredient
Water, Euphorbia Hirta Whole, Glycerin, Hydracrylic Acid,Isopropyl Myristate, Tea Tree Oil, Pseudolarix Amabilis Bark, Resorcinol
Otc - Questions
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