MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE POWDER JOCK ITCH SPRAY) AEROSOL, POWDER [PREMIER BRANDS OF AMERICA INC.]

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  • MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE POWDER JOCK ITCH SPRAY) AEROSOL, POWDER [PREMIER BRANDS OF AMERICA INC.]

MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE POWDER JOCK ITCH SPRAY) AEROSOL, POWDER [PREMIER BRANDS OF AMERICA INC.]
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NDC 56104-301-46
Set ID 0b760890-2767-4d1b-9357-6db1178eccf7
Category HUMAN OTC DRUG LABEL
Packager Premier Brands of America Inc.
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

    ​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 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) or as directed by a doctor
    • supervise children in the use of this product
    • use daily for 2 weeks; if conditions persist, consult a doctor
    • in case of clogging, clear nozzle under running water
    • this product is not effective on scalp or nails
  • ​Other information

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

  • ​Inactive ingredient

    isobutane (propellent), SD alcohol 40-B (14%w/w), stearalkonium hectorite, talc

  • ​Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Premier

    Medicated
    Jock Itch
    Powder Spray
    Miconazole Nitrate 2%

    • Cures most jock itch
    • Relieves itching, chafing, & burning

    NET WT 4.6 FL OZ (130g)

    PB Jock Itch Mic Nit Powder.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazole powder jock itch spray aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOBUTANE (UNII: BXR49TP611)  
    ALCOHOL (UNII: 3K9958V90M)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-301-46130 g in 1 CANISTER; Type 0: Not a Combination Product01/01/201312/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/201312/31/2021
    Labeler - Premier Brands of America Inc. (080051232)
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