Hello,
Product is a travel kit containing a manual toothbrush (class 1 exempt), an otc sodium fluoride toothpaste supplied by a leading manufacturer, and a toothbrush cover all packed into a clear pouch with a backing card.
1) Is a separate NDC number required or recommended for this kit? The toothpaste unit itself has an existing NDC from the manufacturer, naturally.
2) If the pouch is assembled outside the US (backing card, pouch, toothbrush cover manufactured outside of US, toothpaste and toothbrush made in US), how is this kit classified for import purposes (e.g., combination device, etc.).
Thanks,
Aaron
-------------------------------------------
Aaron Onglingswan
Director Product Development & Regulatory Affairs
Dr. Fresh, LLC
Buena Park CA
United States
-------------------------------------------