Remedy Antifungal Powder
FDA Label NDC 53329-169

11 label sections · Submitted to the FDA by Medline Industries, Lp · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Lp for the product Remedy Antifungal (NDC 53329-169). 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, do not use, when using this product, stop use and ask a doctor, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Miconazole nitrate 2.0% w/w

Purpose

Antifungal

Uses

  • for the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis)
  • relieves most itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Warnings

For external use only

Do Not Use

  • on children under 2 years of age unless directed by a doctor
  • on scalp or nails

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control center right away.

Directions

  • Clean the affected area and dry thoroughly
  • Apply a thin layer of powder 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 between spaces in toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • For athlete'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 Information

  • protect from freezing. Avoid excessive heat.
  • do not use if package is damaged
  • keep dry

Inactive Ingredients

Aphanizomenon Flos-Aquae (Algae) Extract, Camellia Sinensis (Green Tea) Leaf Extract, Caprylic/Capric Triglycerides, 7-Dehydrocholesterol, Dipotassium Glycyrrhizate, Ethylene Brassylate, Eugenia Caryophyllus (Clove) Flower Extract, Fragrance, Glycerin, Hydrolyzed Soy Protein, Phospholipids, Silica, Sodium Benzoate, Tocopheryl Acetate, Water, Yeast Ferment Extract, Zea Mays (Corn) Oil, Zea Mays (Corn) Starch

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