Label: MICONAZOLE NITRATE- anti-fungal miconazole athletes foot spray talc free aerosol, powder

  • Category: HUMAN OTC DRUG LABEL

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 December 3, 2019

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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. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    When using this product

    • do not get into eyes or mouth
    • use only as directed

    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 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

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

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    CareOne

    ANTIFUNGAL

    ATHLETE'S FOOT

    POWDER SPRAY

    MICONAZOLE NITRATE 2%

    CURES MOST ATHLETE'S FOOT

    RELIEVES ITCHING, CRACKING, AND BURNING

    TALC- FREE

    NET WT 4.6 (130 g)

    Care One_Antifungal Miconazole AF Powder Spray_50-031CO-01-01.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    anti-fungal miconazole athletes foot spray talc free aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-565
    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
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41520-565-46130 g in 1 CAN; Type 0: Not a Combination Product10/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/20/2017
    Labeler - Foodhold USA (809183973)