Miconazole Nitrate Aerosol, Spray
FDA Label NDC 68016-516

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 Consortium, Llc for the product Miconazole Nitrate (NDC 68016-516). 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:, 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 (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.

Extremely 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 cans 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

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

Do Not Use

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

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 persist, consult a doctor
  • this product is not effective on the scalp or nails

Other Information

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

Inactive Ingredients

acetone, ethoxyglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate

Questions?

call 1-866-964-0939

Principal Display Panel

Premier Value

Continuous

Antifungal Liquid Spray

Miconazole Nitrate 2%

Cures most athlete's foot

Relieves itching, scaling and burning

Net WT 5.3 OZ (150 g)

* Please review the disclaimer below.