Label: MICONAZOLE NITRATE- antifungal miconazole liquid continuous spray aerosol, spray

  • 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 May 28, 2021

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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 itching, burning and scaling
  • Warnings

    For external use only.

    Extremely flammable:

    Contents under pressure. Keep away from fire, sparks, and heated surfaces. Do not puncture or incinerate container. Exposure to temperatures above 120ºF may cause burning, intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    Do not use

    on children under 2 years of age unless directed by a doctor

    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, and 2 weeks for jock itch

    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
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if conditions persists longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

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

  • Inactive ingredients

    acetone, ethoxdiyglycol, propylene glycol, SD alcohol 40-B, tocopheryl acetate

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    GOODSENSE

    Anti-

    Fungal

    Continuous Liquid Spray

    Miconazole Nitrate 2%

    Liquid Countinuous Spray

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

    NET WT. 5.3 OZ (150g)

    spray

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazole liquid continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-136
    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:50804-136-53150 g in 1 CANISTER; Type 0: Not a Combination Product05/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/28/2021
    Labeler - GEISS, DESTIN AND DUNN, INC. (076059836)
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