Funglara Anti Fungal Solution
FDA Label NDC 87028-876

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Funglara Llc for the product Funglara Anti Fungal (NDC 87028-876). 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 drug facts, active ingredient, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Undecylenic Acid 25.0%

Purpose

Anti-fungal

Uses:

  • Proven effective in the treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis).
  • Helps prevent most athlete's foot with daily use.
  • For effective relief of itching, burning and cracking.

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 Use And Ask A Doctor If

  • irritation occurs.
  • There is no improvement within 4 weeks.

Keep Out Of Reach Of Children.

In case of accidental ingestion, contact a physician, emergency medical care facility or Poison Control Center immediately for advice.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions:

• Clean affected areas with soap and warm water and dry thoroughly. • Apply a thin layer of Funglara over affected area twice daily (morning and night) or as directed by a doctor. • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. • For athlete's foot pay special attention to spaces between the toes. • For athlete's foot and ringworm, use daily for 4 weeks. • To prevent athlete's foot, apply once
or twice daily (morning and/or night). If condition persists longer, consult a doctor. • This product is not effective on the scalp or nails.

Other Information:

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Acetic Acid, Aloe Barbadensis Leaf Juice, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Thymus Vulgaris (Thyme) Extract, Water (Aqua)

Package Labeling:

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