Label: JOCK ITCH- miconazole nitrate 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 October 13, 2020

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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® AF Powder Spray active ingredient

    Jock Itch Powder Spray

    MICONAZOLE NITRATE 2% / ANTIFUNGAL

    GOES ON DRY

    Clinically proven to cure most jock itch

    Relieves itching, burning, scaling & chafing

    NEW WT 4.6 OZ (130 g)

    Jock Itch Powder Spray Label
  • INGREDIENTS AND APPEARANCE
    JOCK ITCH 
    miconazole nitrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1497
    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:0363-1497-90130 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/23/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/23/2018
    Labeler - Walgreen Company (008965063)