Label: MEIJER JOCK ITCH RELIEF ANTIFUNGAL- miconazole nitrate spray

  • NDC Code(s): 23667-808-01
  • Packager: Formulated Solutions, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • Drug Facts

  • Active ingredient

    Miconazole Nitrate 2%

    Purpose

    Antifungal

  • Uses

    • proven clinically effective in the treatment of most Jack itch (tinea cruis) 
    • for effective relief if itching, cracking, burning, scalling and discomfort, and chating associated with jock itch
  • Warnings

    For external use only

    Flammable: Do not use while smoking or near heat or flame

    Do not use

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

    When using this product

    • avoid contact with the eyes
    • use only as directed intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
    • contents under pressure. Do nor punture or incinerate. Do not store at temperature above 120°F (49°C).

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 2 weeks

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • 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
    • use daily for 2 weeks
    • if condition persist longer, ask a doctor
    • this product is not effective on the scalp or nails
    • in case of clpgging, clean nozzle with a pin
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive Ingredients

    alcohol denat, aluminum starch octenylsuccinate, isobutane, isopropyl myristate, propylene carbonate, sorbitan monoleate, stearalkonium hectorite, talc

  • Questions or comments?

    1-800-719-9260

  • Package Labeling:

    Miconazole 808

  • INGREDIENTS AND APPEARANCE
    MEIJER JOCK ITCH RELIEF ANTIFUNGAL 
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:23667-808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ISOBUTANE (UNII: BXR49TP611)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    SORBITAN (UNII: 6O92ICV9RU)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23667-808-01130 g in 1 CAN; Type 0: Not a Combination Product01/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00501/20/2017
    Labeler - Formulated Solutions, LLC (143266687)
    Establishment
    NameAddressID/FEIBusiness Operations
    Formulated Solutions, LLC143266687manufacture(23667-808)
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