Active Ingredient
Undecylenic Acid 25%
Lunavia Antifungal Spray
FDA Label NDC 85210-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xf Agencija Limited for the product Lunavia Antifungal (NDC 85210-002). 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 active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antifungal
Uses
For the treatment of athlete's foot, jock itch, and ringworm.
Warnings
For external use only.
Directions
■ Read all warnings and directions.
■ Use only as directed.
■ Clean the affected area with soap and water and dry thoroughly.
■ Remove cap from Bottle.
■ Spray the bottle on and inside shoes, socks, and feet until all areas are covered.
■ Spray a thin layer of the product over the contaminated area twice daily (morning and night) or as directed by a doctor.
■ For athlete's foot, pay special attention to spaces between the toes; wear well-fitting,ventilated shoe, and change shoes and socks at least once daily.
Other Information
■ Store at 15°-30°C (59° - 86°F)
■ Keep cap on bottle when not in use
Inactive Ingredients
Deionized water, Polypropylene Glycol, Melaleuca Alternifolia Leaf Oil (Tea Tree), Eucalyptus Globulus Leaf oil, Mentha Piperita (Peppermint) Oil, Citrus Limon (Lemon) Oil, Clove Bud Oil.
* Please review the disclaimer below.
