Label: MODEL AA-1218PAN- kit

  • NHRIC Code(s): 27860-005-02
  • Packager: Aerospace Accessory Service, Inc
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated May 5, 2021

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  • Aerospace Accessory Service

    Aerospace Accessory Service

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    Label

  • INGREDIENTS AND APPEARANCE
    MODEL AA-1218PAN 
    first aid kit with drug kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:27860-005
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:27860-005-021 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Item Code (Source)NDC:46414-7777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/14/1976
    Part 2 of 2
    BZK PADS 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:67777-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/05/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceABC01/01/2015
    Labeler - Aerospace Accessory Service, Inc (859100547)
    Registrant - Aerospace Accessory Service, Inc (859100547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aerospace Accessory Service, Inc859100547manufacture, repack