Miconazole Nitrate
FDA Label NDC 63868-180

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association for the product Miconazole Nitrate (NDC 63868-180). 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, flammable:, when using this product, stop use and ask a doctor if, keep out of reach of children., 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 symptoms of athlete's foot, including itching burning and cracking

Warnings

For external use only.

Flammable:

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120°F

When Using This Product

  • do not get into eyes or mouth
  • use only as directed

    • Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

Stop Use And Ask A Doctor If

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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

Directions

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over affected area twice daily (morning and night)
  • 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
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
  • this product is not effective on the scalp or nails
  • in case clogging, clear nozzle under running water

Other Information

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

Inactive Ingredients

SD alcohol 40-B(10%w/w), isobutane (propellant), stearalkonium hectorite, talc

Questions?

call 1-866-964-0939

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Quality Choice

Talc- Free

Athlete's Foot

Antifungal Powder Spray

Miconazole Nitrate 2%

  • Cures Most Athlete's Foot
  • Relieves Itching, Cracking, and Burning

    • NET WT 4.6 OZ (130 g)

* Please review the disclaimer below.