Label: JOCK ITCH RELIEF- miconazole nitrate spray

  • NDC Code(s): 41250-497-90
  • 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 November 29, 2018

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    •
    proven clinically effective in the treatment of most jock itch (tinea cruris)
    •
    for effective relief of itching, burning, scaling and discomfort, and chafing 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 not puncture 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 persists longer, ask a doctor
    •
    this product is not effective on the scalp or nails
    •
    in case of clogging, 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 monooleate, stearalkonium hectorite, talc

    Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Compare to Lotrimin® active ingredient

    jock itch relief

    Miconazole nitrate 2%

    Antifungal

    Clinically Proven to Cure Most Jock Itch Fungus

    POWDER SPRAY | GOES ON DRY

    Relieves Itching, Burning, Scaling and Chafing

    NET WT 4.6 OZ (130 g)

    jock itch relief image
  • INGREDIENTS AND APPEARANCE
    JOCK ITCH RELIEF 
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41250-497
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2 g  in 100 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 MONOOLEATE (UNII: 06XEA2VD56)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorWHITE (off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41250-497-90130 g in 1 CAN; Type 0: Not a Combination Product03/29/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C03/29/2017
    Labeler - Meijer Distribution Inc (006959555)
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