Label: ACL4SP SINGLE SHOT EPIDURAL- kit

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

Drug Label Information

Updated April 1, 2015

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  • Drug Facts

    Povidone-iodine

  • PURPOSE

    Antiseptic

    Antiseptic skin preparation

  • 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

    Stop use and ask a doctor if

    -redness, irritation, swelling or pain persists or increases

    -infection occurs

    Avoid pooling beneath patient

    Avoid excessive heat. Store at room temperature.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • INSTRUCTIONS FOR USE

    Apply locally as needed.

  • OTHER SAFETY INFORMATION

    1% titratable iodine latex free for hospital or professional use only

  • INACTIVE INGREDIENT

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • QUESTIONS

    1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST)

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    Povidone Iodine Solution

  • PRINCIPAL DISPLAY PANEL

    Package Label Display Panel

    ACL4SP

  • INGREDIENTS AND APPEARANCE
    ACL4SP SINGLE SHOT EPIDURAL 
    regional anesthesia kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55553-445
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:55553-445-0230 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.137835299manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.107255002manufacture
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