MICONAZOLE NITRATE (JOCK ITCH SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]

MICONAZOLE NITRATE (JOCK ITCH SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]
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NDC 49035-135-46
Set ID 76259769-9923-4856-a160-a738bc8a72f0
Category HUMAN OTC DRUG LABEL
Packager Wal-Mart Stores, Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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 delibrately 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 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 conditions 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 20 oC and 30 oC (68 o and 86 oF)

  • Inactive ingredient

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

  • Questions?

    1-888-287-1915

  • Principal Display Panel

    equate

    Jock Itch

    Powder Spray

    Miconazole Nitrate 2%

    Antifungal

    Cures Most Jock Itch

    Talc-free

    Relieves itching, chafing and burning

    NET WT 4.6 OZ (130 g)

    jock itch

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    jock itch spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.3 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49035-135-46130 g in 1 PACKAGE; Type 0: Not a Combination Product02/28/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/28/2019
    Labeler - Wal-Mart Stores, Inc. (051957769)

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