Miconazole Nitrate Aerosol, Spray
FDA Label NDC 50804-136

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geiss, Destin And Dunn, Inc. for the product Miconazole Nitrate (NDC 50804-136). 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, extremely flammable:, 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

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

Uses

  • cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
  • relieves itching, burning and scaling

Warnings

For external use only.

Extremely Flammable:

Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 120°F may cause burning, intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

When Using This Product

  • avoid contact with the eyes or mouth
  • use only as directed

Stop Use And Ask A Doctor If

  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm, and 2 weeks for jock itch

Keep Out Of Reach Of Children.

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

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer 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 to spaces between the 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 conditions persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

store between 20° and 30°C (68° and 86°F)

Inactive Ingredients

acetone, ethoxdiyglycol, propylene glycol, SD alcohol 40-B, tocopheryl acetate

Questions?

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