Label: MICONAZOLE NITRATE- athletes foot 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 January 13, 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.

    Extremely 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

    • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
    • irritation occurs

    ​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) or as directed by a doctor
    • supervise children in the use of this productfor 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
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if conditions persist, consult a doctor
    • this product is not effective on the scalp or nails
  • ​Other information

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

  • ​Inactive ingredients

    acetone, ethoxyglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate

  • ​ ​Questions?

    call 1-866-964-0939

  • ​Principal Display Panel

    CVS Health

    Antifungal

    Athlete's Foot Spray
    Liquid Spray

    Miconazole Nitrate 2%

    • Cures most athlete's foot
    • Relieves itching, burning, scaling and cracking

    NET WT 5.3 OZ (150g)

    CVS_Antifungal Miconazole Athletes Foot Liquid Spray_50-069CV.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    athletes foot spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-097
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE3 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-097-53150 g in 1 CAN; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2014
    Labeler - CVS Pharmacy (062312574)
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