Otc - Active Ingredient
Undecylenic Acid 25%
Luovue Antifungal Pen Gel
FDA Label NDC 88022-001
12 label sections · Submitted to the FDA by Deosperavi Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Deosperavi Llc for the product Luovue Antifungal Pen (NDC 88022-001). 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 - keep out of reach of children, indications & usage, 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
Otc - Do Not Use
on children under 2 years of age unless directed by a doctor.
Otc - When Using
When using this product
avoid contact with the eyes.
Stop and ask a doctor if
irritation occurs or if there is no 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 athlets'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, HydracrylicAcid, Isopropyl Myristate, Tea Tree Oil, PseudolarixAmabilis Bark, Resorcinol
Otc - Questions
Email: [email protected]
Visit www.vigorwells.com
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