Regulatory Open Forum

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  • 1.  Zinc Oxide

    Posted 23-Mar-2017 08:00
    Can someone inform me about Zinc Oxide and anynew regulations regarding drug status.


  • 2.  RE: Zinc Oxide

    Posted 24-Mar-2017 08:28
    Hi Susan.

    I'm not aware of any major changes at this point to ZnO for drug products.  At least in the US it is a skin protectant and sunscreen by monograph.  I guess something might have changed in the EU or in Asia with respect to approvals of ZnO even in nano form in the EU for use in sunscreens (but then again sunscreens are cosmetics in the EU) but nothing that I have heard/seen that would implicate any major changes to ZnO in most of the world.  Canada maybe?  Or China?

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    Victor Mencarelli
    Director - Regulatory Affairs
    Hain Celestial Group
    United States
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    Original Message


  • 3.  RE: Zinc Oxide

    Posted 24-Mar-2017 13:27
     It is also used as a device in dental products.

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    Corey Jaseph RAC
    Regulatory Affairs Manager
    Ultradent Products, Inc.
    South Jordan UT
    United States
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    Original Message


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