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Japan Requires Mandatory Precautions on Packages for Quasi-Drugs Containing Chlorhexidine Gluconate

  •   25 Dec 2017
  •    Jo Zhou
  •  442
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    Takehome:

    Japan stipulated that if chlorhexidine gluconate or chlorhexidine is used in quasi-drugs as an active ingredient, certain "use precautions" should be listed on the product container.

    This decision addresses the allergy or shock (anaphylaxis) associated with chlorhexidine use. Normally this ingredient is used in outer skin disinfectants and scratch disinfectants. For those products, precautions should be added on containers or encapsulations as follows:

    1. Those who have allergy symptoms due to chlorhexidine please do not use this product;
    2. In rare cases, severe symptoms of shock (anaphylaxis) may occur. If urticarial lesion, breathlessness, loss of consciousness happened, please immediately stop using the product and visit the doctor as soon as possible; for people who have never experienced such symptoms, it is highly suggested to consult with a doctor before using.

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