Miconazole Nitrate Aerosol, Powder
FDA Label NDC 83324-233

14 label sections · Submitted to the FDA by Chain Drug Marketing Association · 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 83324-233). 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 (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • relieves itching, burning and cracking

Warnings

For external use only.

Extremely Flammable:

Keep away from fire, sparks, and heated surfaces.Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Do Not Use

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

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

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

Other Information

  • store between 20° and 30°C (68° and 86°F)
  • if nozzle clogs, clean with a pin

Inactive Ingredients

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

Questions?

Call 1-866-964-0939

Principal Display Panel

QC

Quality Choice

Athlete's

Foot

Powder

Spray

Miconazole Nitrate 2%

Antifungal

Cures Most Athlete's Foot

Comforts & Refreshes

Talc- Free

Relieves:

Itching

Burning

Cracking

NET WT.

4.6 OZ. (130 g)

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