IBSPOT.com Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA confirmed through laboratory analyses that “Taoscare Motion Sickness Patch” and “Navabelle Motion Sickness Patches” purchased on www.ibspot.com contained the ingredients diphenhydramine, diphenhydramine N-oxide, and diclofenac, which are not listed on the product labels.

Passage 2

No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs and the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).