RX-SPECIMEN COLLECTION KIT (SPECIMEN COLLECTION KIT) KIT [MAS MANAGEMENT GROUP INC.]

RX-SPECIMEN COLLECTION KIT (SPECIMEN COLLECTION KIT) KIT [MAS MANAGEMENT GROUP INC.]
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NDC 10819-3740-1, 33358-0149-1, 69677-030-01
Set ID a44b385e-7060-4c19-933a-7565319de438
Category HUMAN PRESCRIPTION DRUG LABEL
Packager MAS Management Group Inc.
Generic Name
Product Class
Product Number
Application Number ANDA078010
  • WARNINGS AND PRECAUTIONS

    Rx Only

  • COMPONENTS

    Kit Contains

    1 x Furosemide 20mg Tablet

    3 x Benzalkonium Chloride Towelettes

    1 x Sterile Urine Collection Cup with Temperature Strip

    1 x Specimen Bag

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DIAGRAM OF DEVICE

    specimen cup

  • PRINCIPAL DISPLAY PANEL

    image description

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  • INGREDIENTS AND APPEARANCE
    RX-SPECIMEN COLLECTION KIT 
    specimen collection kit kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69677-030
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69677-030-011 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package07/23/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKAGE
    Part 21 PACKET 3 mL
    Part 1 of 2
    FUROSEMIDE 
    furosemide pill
    Product Information
    Item Code (Source)NDC:33358-0149
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5) FUROSEMIDE20 mg
    Inactive Ingredients
    Ingredient NameStrength
    MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code RE22
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33358-0149-11 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07801007/23/2015
    Part 2 of 2
    BENZALKONIUM CHLORIDE 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:10819-3740
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0013 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3740-13 mL in 1 PACKET; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07801007/23/2015
    Labeler - MAS Management Group Inc. (079363782)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAS Management Group Inc.079363782manufacture(69677-030)
    Establishment
    NameAddressID/FEIBusiness Operations
    RxChange Co781126805manufacture(33358-0149)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposable International, Inc800777117manufacture(10819-3740)

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