Miconazole Nitrate Aerosol, Spray
FDA Label NDC 56104-903

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 56104-903). 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 itching, burning and scaling

Warnings

For external use only.

Flammable:

Keep away from heat, sparks, and open flame. Contents under pressure.Do not puncture or incinerate. Do not store at temperature above 120°F.

When Using This Product

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

​Stop Use And Ask A Doctor If

  • irritation occurs
  • there is 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.

​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
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • if conditions persist, 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

SD ALCOHOL 40-B, ETHOXYGLYCOL, PROPYLENE GLYCOL, ACETONE, TOCOPHERYL ACETATE

​ ​Questions?

call 1-866-964-0939

​Principal Display Panel

premier ​

solutions

Antifungal

ATHLETE'S

FOOT

Continuous Liquid Spray

MICONAZOLE NITRATE 2% /

ANTIFUNGAL

CURES MOST
ATHLETE'S FOOT

Relieves itching, scaling & burning

Comforts & refreshes

SPRAYS AT ANY ANGLE

NET WT. 5.3 OZ. (150g)

* Please review the disclaimer below.