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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 18, 2024

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  • 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.

    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 120ºF

    ​When using this product

    • avoid contact with the eyes or mouth
    • use only as directed

    Intentional misuse by deliberately concentrating and inhaling contents cans 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

    ​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
    • 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
    • in case clogging, clear nozzle under running water
  • ​Other information

    store between 20º and 30ºC (68ºF and 86º)

  • ​ ​Inactive ingredients

    isobutane (propellant), SD alcohol 40-B(10%w/w), stearalkonium hectorite, talc

  • ​Questions?

    call 1-866-964-0939

  • ​Principal Display Panel

    Athlete's Foot

    Antifungal Powder Spray

    Miconazole Nitrate 2%

    Cures most symptoms of athlete's foot

    Relieves itching, cracking and burning

    NET WT 4.6 OZ (130g)

    Artwork

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazole nitrate antifungal powder spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-212
    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
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-212-00130 g in 1 CAN; Type 0: Not a Combination Product09/27/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/27/2021
    Labeler - Better Living Brands (009137209)
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