Conclusions: Label Comprehension Study
Over half of the acute hives study subjects appropriately de-selected the product in the personal use question and scenario responses demonstrate that this population understands the warnings.
- Notably this result was achieved with draft labeling that requires refinement
- We are committed to work with FDA to refine the labeling to improve comprehension among these consumers
Based on self-selection and response to scenarios, consumers with a physician diagnosis of CIU understand that this product is for them and are likely to use it correctly.