MICONAZOLE NITRATE (JOCK ITCH SPRAY TALC FREE) AEROSOL, SPRAY [AMERICAN SALES COMPANY]

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MICONAZOLE NITRATE (JOCK ITCH SPRAY TALC FREE) AEROSOL, SPRAY [AMERICAN SALES COMPANY]
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NDC 41520-566-46
Set ID 4354b71e-6268-440d-b916-0403c6fc3ddb
Category HUMAN OTC DRUG LABEL
Packager American Sales Company
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • cures most jock itch (tinea cruris)
    • relieves symptoms of jock itch including 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.

    When using this product

    • do not get into eyes or mouth
    • use only as directed. Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 2 weeks for jock itch

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age. Do not use for diaper rash. Do not use on children under 2 years of age unless directed by a doctor.

  • 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 conditions persist, consult a doctor
    • this product is not effective on scalp or nails
    • in case of clogging, clear nozzle under running water
  • Inactive ingredient

    Disteardimonium Hectorite, Isobutane, Kaolin, SD Alcohol 40-B, Zea Mays (Corn) Starch

  • Questions?

    Call 1-866-964-0939

  • PRINCIPAL DISPLAY PANEL

    CareOne

    ANTIFUNGAL

    JOCK ITCH

    POWDER SPRAY

    MICONAZOLE NITRATE 2%

    CURES MOST JOCK ITCH

    RELIEVES ITCHING, CHAFING, AND BURNING

    TALC- FREE

    NET WT 4.6 OZ (130 g)

    Care One_Antifungal Miconazole Jock Itch Powder Spray_50-032CO-01.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    jock itch spray talc free aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-566
    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:41520-566-46130 g in 1 CAN; Type 0: Not a Combination Product10/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/20/2017
    Labeler - American Sales Company (809183973)
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