Miconazole Nitrate Aerosol, Spray
FDA Label NDC 0363-7418

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Walgreens Company for the product Miconazole Nitrate (NDC 0363-7418). 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, indications & usage, 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

Miconozole nitrate2%

Purpose

Antifungal

Indications & Usage

Uses

  • cures most athlete's foot (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
  • relieves symtoms 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 o F

When Using This Product

  • do not get into eyes or mouth
  • use only as directed Intentional misues by deliberatley concentrating and inhaling comtents can 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 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 condition persists, consult a doctor
  • this product is not effective on scalp or nails
  • in case of clogging, clear nozzle under running water

Other Infomation

Store between 20 o and 30 o C (68 o and 86 o F)

Inactive Ingredients

isobutane (propellant), SD alcohol 40-B (14% w/w), stearalkonium hectorite, talc

Questions

Call 1-866-964-0939

Principal Display Panel

Leader

Medicated

Miconazole Nitrate 2%

Powder Spray

  • Cures Most Jock Itch
  • Relieves Itching, Chafing and Burning

    • NET WT 4.6 OZ (130g)

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