Label: A2628 NERVE BLOCK - regional anesthesia kit   

  • Label RSS
  • NDC Code(s): 51688-8637-2, 52380-0001-3
  • Packager: Smiths Medical ASD, Inc.
  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 11/12

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  • DESCRIPTION

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

    3/4 Ounce Povidone Iodine Packet

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  • 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.

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Povidone Iodine Solution

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  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    A2628

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  • INGREDIENTS AND APPEARANCE
    A2628 NERVE BLOCK 
    regional anesthesia kit kit
    Product Information
    Product Type MEDICAL DEVICE Item Code (Source) NHRIC:51688-8637
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:51688-8637-2 10 in 1 CASE
    1 1 in 1 PACKAGE, COMBINATION
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 PACKET 22.5 mL
    Part 1 of 1
    APLICARE POVIDONE-IODINE  
    povidone-iodine solution
    Product Information
    Item Code (Source) NDC:52380-0001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (IODINE) POVIDONE-IODINE 0.10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE  
    SODIUM PHOSPHATE, DIBASIC  
    SODIUM HYDROXIDE  
    NONOXYNOL-9  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:52380-0001-3 22.5 mL in 1 PACKET
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/01/1984
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    premarket notification K965017 12/14/2005
    Labeler - Smiths Medical ASD, Inc. (137835299)
    Establishment
    Name Address ID/FEI Business Operations
    Smiths Medical ASD, Inc. 137835299 relabel, manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Aplicare, Inc. 107255002 manufacture
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