Lunavia Antifungal Foot Balm Ointment
FDA Label NDC 85210-003

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 Foot Balm (NDC 85210-003). 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, directions, warnings, when using this product, stop use and ask doctor if, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Zinc Undecylenate 10%

Purpose

Antifungal

Uses

  • For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • For effective relief of itching, cracking, burning, redness, soreness, irritation and discomfort

Directions

Apply a thin layer over affected area twice daily (morning & night) or as directed by a doctor.

Warnings

For External Use only.

When Using This Product

  • Do not get into eyes

Stop Use And Ask Doctor If

  • irritation occurs or allergic reaction

Inactive Ingredients

Macadamica Oil, Organic Coconut Oil, Organic Shea Butter, Safflower Seed Oil, Sweet Almond Oil, Beeswax, Olive Oil, Essential Oils (Tea Tree, Eucalyptus, Lavender, Rosemary, Geranium), Tocopherol (Vit-E)

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