TUN-L-XL 191-2540 () KIT [EPIMED INTERNATIONAL]

TUN-L-XL 191-2540 () KIT [EPIMED INTERNATIONAL]
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NDC 60816-2540-1
Set ID a6e0cadc-0f48-4d1d-9a4c-f4c91c1171a1
Category MEDICAL DEVICE
Packager Epimed International
Generic Name
Product Class
Product Number
Application Number K954584
  • 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

    Wiley Spinal

  • INGREDIENTS AND APPEARANCE
    TUN-L-XL  191-2540
    catheter, conduction, anesthetic kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:60816-2540
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:60816-2540-11 in 1 PACKAGE
    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
    122.5 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK95458410/08/1996
    Labeler - Epimed International (799751953)
    Establishment
    NameAddressID/FEIBusiness Operations
    Epimed International799751953relabel, manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.107255002manufacture

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