Label: ACL13KC SINGLE SHOT EPIDURAL- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated June 25, 2013

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  • DESCRIPTION

    APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution
    [Aplicare, Inc.]

    3/4 Ounce Povidone Iodine Packet

  • WARNINGS

    Povidone-iodine 10%

    Antiseptic

    Warnings

                Do not use

    • if allergic to iodine
    • in the eyes

                For external use only

                Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

                Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

                Avoid pooling beneath patient

                Keep out of reach of children.  In case of accidental ingestion, seek professionalassistance or consult a poison control center immediately.

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Povidone Iodine Solution

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    ACL13KC

  • INGREDIENTS AND APPEARANCE
    ACL13KC SINGLE SHOT EPIDURAL 
    regional anesthesia kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55553-439
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:55553-439-0230 in 1 CASE
    11 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 PACKET 22.5 mL
    Part 1 of 1
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source)NDC:52380-0001
    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 (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0001-322.5 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/1984
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK96501712/14/2005
    Labeler - Clint Pharmaceuticals, Inc. (609197785)
    Registrant - Smiths Medical ASD, Inc. (137835299)
    Establishment
    NameAddressID/FEIBusiness Operations
    Smiths Medical ASD, Inc.137835299relabel, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.107255002manufacture