Label: MICONAZOLE NITRATE 2%- jock itch 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 October 28, 2021

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruris)
    • relieves itching, burning and chafing associated with jock itch
  • Warnings

    For external use only.

    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. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    When using this product

    • do not get into eyes or mouth
    • use only as directed

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 2 weeks

    Do not use

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

    Keep out of the 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
    • use daily for 2 weeks; if condition persists, consult a doctor
    • this product is not effective on the scalp or nails
    • if nozzle clogs, clean with a pin
  • Other Information

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

  • Inactive ingredients

    disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    ANTIFUNGAL

    Jock Itch

    Powder Spray

    Miconazole Nitrate 2%

    • Cures most jock itch
    • Relieves itching, chafing and burning
    • Talc-free

    NET WT 4.6 OZ (130g)

    artwork

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 2% 
    jock itch spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5353
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.3 g  in 131 g
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5353-00131 g in 1 CAN; Type 0: Not a Combination Product10/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/28/2021
    Labeler - Walgreens Company (008965063)