Label: MICONAZOLE NITRATE- antifungal miconazole powder spray aerosol, spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 20, 2021

If you are a consumer or patient please visit this version.

  • 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)

    Artwork

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazole powder spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-7418
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M) 18.2 g  in 130 g
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-7418-00130 g in 1 CANISTER; Type 0: Not a Combination Product10/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/14/2021
    Labeler - Walgreens Company (008965063)