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Outer Label for Case Carton Box

  • 1.  Outer Label for Case Carton Box

    Posted 02-Mar-2017 10:53

    Can anyone direct me to specific requirements for the outer labelling for the shipping case carton box?  I have already looked through all the FDA Guidance for Industry pertaining to general labeling requirements, as well as the blue book memo on medical device labeling.

    BACKGROUND: the device in the case carton is a liquid which is flammable and presents a small health hazard.  The device labeling and package insert contain the required symbology and explanantions.  The shipping packaging has been UN 4G certified for hazardous goods shipment.

    Again, this would be for the outer label you put on the case carton box used for shipping.  Any guidance would be appreciated.

    Will Coulston | M.S., PMP
    Quality and Regulatory Manager

    Wrk: 210-375-9349
    Cell:  210-870-6534

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