Hi Anon.
In addition to Anne's valuable input here - there is also a guidance document from FDA that nicely shows how the graphics are expected to show on different package types, sizes, and configurations.
As for your question about gift boxes - the same rules apply to these as would apply to the standard individual item in the set. So if there is an OTC product in the gift box, then the gift box will require an acceptable Drug Facts Box with all of the necessary information in the correct order. The cosmetics in the gift box will also require all of the necessary information as if they were being sold as an individual item. So if you have a lipstick, an eyeshadow and an SPF-containing foundation in the box you will need a drug facts box for the SPF-containing foundation plus you will need an ingredient list for the lipstick, an ingredient list for the eyeshadow, and will need all of your standard information like net contents, directions for use and warnings for the cosmetic products if necessary, and the address of the company.
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Victor Mencarelli MS
Global Director Regulatory Affairs
New YorkNY
United States
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Original Message:
Sent: 24-Jun-2024 12:29
From: Anonymous Member
Subject: OTC Medical devices Labelling requirements & OTC / cosmetic Gift box labelling requirements US
This message was posted by a user wishing to remain anonymous
Hi Team ,
I will like your help finding the most up to date accurate information to create an infographic on the labelling requirements for both OTC medical devices and explanation on the statement of identity for MD , as well as the requirements for OTC/ Cosmetic gift boxes.
Thank you in advance.