Miconazole Nitrate Aerosol, Powder
FDA Label NDC 56104-907

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Premier Brands Of America Inc. for the product Miconazole Nitrate (NDC 56104-907). 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, do not use, 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 (tinea pedis), ringworm (tinea corporis) and jock itch (tinea 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. Intentional misuse by deliberately concentrating and inhaling 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; 2 weeks for jock itch

Do Not Use

on children under 2 years of age unless directed by a doctor.

Directions

  • wash the affected area and dry thoroughly
  • shake can well and spray a thin layer of the product 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
  • 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
  • if nozzle clogs, clean with a pin

Other Information

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

Inactive Ingredients

DISTEARDIMONIUM HECTORITE, ISOBUTANE, KAOLIN, SD ALCOHOL 40-B, ZEA MAYS (CORN) STARCH,

Questions?

Call 1-866-964-0939

Principal Display Panel

Soothing

Feet!

"Your Daily Foot Spa"

In a Can

Antifungal

Powder Spray

Miconazole Nitrate 2%

Cures most athlete's foot

Relieves itching,cracking

& burning

Talc- free

NET WT 4.6 OZ. (130 g)

* Please review the disclaimer below.