Fungazol Athlete Foot Cream
FDA Label NDC 83004-025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rida Llc for the product Fungazol Athlete Foot (NDC 83004-025). 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, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Miconazole Nitrate USP, 2%

Purpose

Antifungal

Uses

  • cures most athlete’s foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany theses conditions

Warnings

For external use only

Do not use

  • on nails or scalp
  • in or near the mouth or eyes
  • for vaginal yeast infections

    • When using this product do not get into eyes. If eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if too much irritation occurs or gets worse.

    Keep out of the reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and over:

  • wash affected area with soap and water and dry completely before applying
  • for athlet's foo twear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
  • between the tose only:apply twice a day (morning and night) for 1 weekor as directed by doctor
  • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeksor as directed by doctor
  • for jock itch and ringworm: apply once a day (morning ornight) for 1 weekor as directed by a doctor
  • wash hands after each use
  • Children under 12 years: ask a doctor

Other Information

  • do not use if seal on the tube is broken or is not visible. 
  • store at controlled room temperature 20-25°C (68-77°F)

Inactive Ingredients

Organic tea tree oil, benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, olive oil, potassium hydroxide, propylene glycol, water, stearyl alcohol

Questions Or Comments?

(888) 885-6137

Product Label

Image Description (Image 13)

Image Description (Image 13)

* Please review the disclaimer below.