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

  • NDC Code(s): 41250-196-46
  • Packager: Meijer Distribution Inc
  • 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 January 11, 2023

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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 can be harmful or fatal.

    When using this product

    • avoid contact with the 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.

    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) 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 persists, consult a doctor
    • this product is not effective on the scalp or nails
    • if nozzle clogs, clean with a pin
  • Other information

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

  • Inactive ingredients

    disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    meijer

    MEDICATED

    athlete's foot

    Miconazole Nitrate | Antifungal

    Powder Spray

    TALC-FREE

    Cures most athlete's foot

    Relieves itching, cracking & burning

    NET WT 4.6 OZ (130g)

    AF Miconazole Powder Spray

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    athletes foot powder spray talc free aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-196
    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:41250-196-46130 g in 1 CAN; Type 0: Not a Combination Product04/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/04/2018
    Labeler - Meijer Distribution Inc (006959555)
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