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  • 1.  Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    This message was posted by a user wishing to remain anonymous
    Posted 09-Jul-2021 09:09
    This message was posted by a user wishing to remain anonymous

    How would I determine what is the appropriate, current nomenclature for an inactive ingredient in an OTC drug?  Would it be CTFA dictionary, even though it isn't a cosmetic, or some other resource?  Thank you in advance.


  • 2.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    Posted 10-Jul-2021 14:13
    This depends on the claims. If there are no cosmetic claims, the inactive must be in the USP and use the correct names in alphabetical order. If you make any cosmetic claims, you must use INCI designations in predominate order down to 1%  and any order below 1%

    David C. Steinberg, FRAPS

    ------------------------------
    David Steinberg,FRAPS
    President
    Steinberg & Associates, Inc.
    Pompton Plains NJ
    USA
    609-902-8860
    ------------------------------

    Original Message


  • 3.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    This message was posted by a user wishing to remain anonymous
    Posted 12-Jul-2021 08:45
    This message was posted by a user wishing to remain anonymous

    Thank you.  The ingredient is USP and is listed in the UNII database with synonyms.  Can any of those synonyms be used?
    Original Message


  • 4.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    Posted 12-Jul-2021 08:54
    It depends on the claims made

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    David Steinberg,FRAPS
    President
    Steinberg & Associates, Inc.
    Pompton Plains NJ
    USA
    609-902-8860
    ------------------------------

    Original Message


  • 5.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jul-2021 08:07
    This message was posted by a user wishing to remain anonymous

    There aren't cosmetic claims.  It is an OTC monograph product.
    Original Message


  • 6.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    This message was posted by a user wishing to remain anonymous
    Posted 13-Jul-2021 08:10
    This message was posted by a user wishing to remain anonymous

    There wouldn't be an cosmetic claims.  It's is an OTC monograph drug without only monograph claims.
    Original Message


  • 7.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    Posted 13-Jul-2021 10:08
    Hi Anon.

    My opinion is that the UNII name listed should be the name used for labeling purposes if the name is listed in the FDA's website.  Since the product does not contain cosmetic claims, the use of INCI ("CTFA") names would be inappropriate and the listing must be in alphabetical order.  By using the UNII name listed it avoids questions later from FDA both in terms of nomenclature itself and in the order of the inactive ingredients on the label in the Drug Facts Box.  I usually don't like using the synonyms in general because the UNII name is rather specific and the reg actually references the UNII names.

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    Victor Mencarelli
    Global Director Regulatory Affairs
    MelvilleNY
    United States
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    Original Message


  • 8.  RE: Established name (appropriate nomenclature) for inactive ingredient in OTC drug.

    This message was posted by a user wishing to remain anonymous
    Posted 14-Jul-2021 13:55
    This message was posted by a user wishing to remain anonymous

    Thank you!
    Original Message


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