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  • 1.  OTC Labeling Requirments

    Posted 24-Jul-2018 07:45
    ​​Hello,

    I am trying to create the pouch artwork/label for a BZK Towelette, while trying to meet the requirements of 21 CFR 201.66 - Labeling Requirements for OTC Drugs.  I am struggling to get all the required information on the pouch, while meeting the minimum font size requirements. Has anyone had any experience with requesting a wavier of labeling requirements from the FDA? How strict is the FDA with enforcing the font size requirements. Will they consider the product misbranded if the font size is too small?

    Any insight to this topic would be greatly appreciated.

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    William Bagnasco
    QA/RA Manager
    Ronkonkoma NY
    United States
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  • 2.  RE: OTC Labeling Requirments

    Posted 24-Jul-2018 13:45
    ​Hi William.

    If you look deeply enough into the actual text of 201.66 there are certain allowances for "small packages" and the FDA defined what they consider a small package in the regulations.  Additionally, the regulations do state that if (I think) more than 60% of the total label area would be composed of the Drug Facts box, you have the ability to use alternate labeling (cards, attachments, etc.) or secondary labeling to fully comply.  I would also caution that you want to closely check whether your product still meets the requirements for the individual monograph here because there have been some significant and serious changes to the monograph I suspect you are using.

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    Victor Mencarelli
    Director Regulatory Affairs
    United States
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    Original Message


  • 3.  RE: OTC Labeling Requirments

    Posted 25-Jul-2018 02:47
    Hello William,

    The labeling (wording and size) is very important in OTC.
    You always have to look at it as you are the intended user in aspect of safety and effectiveness.
    I would prepare a partly risk analysis for the items that you feel that the reviewer may have questions about (like size) and provide the rational for each.

    Yoram Levy, Qsite
    Israel

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    [Yoram] [Levy]
    [General Manager]
    [Qsite]
    [Binyamina]
    [Israel]
    ------------------------------

    Original Message


  • 4.  RE: OTC Labeling Requirments

    Posted 26-Jul-2018 07:28
    Hi William

    We have you used peel-back labels for small packages. So the product name, strength, ingredients, net contents remain on the front with a peel-back sign and remaining drug facts go on back of the label.

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    Vini Modi, MS
    RA/Compliance
    PA
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    Original Message


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