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Guidance for Industry and Food and Drug Administration Staff
Recommendations for Labeling Medical Products to Inform Users that
the Product or Product Container is not Made with Natural Rubber Latex

Document issued on: December 2, 2014

4. Recommended Labeling Statement

Currently, there are no regulations requiring a manufacturer to state that natural rubber latex was not used as a material in their medical product, its container and/or its packaging. If a manufacturer elects to include a statement in medical product labeling indicating that natural rubber latex or synthetic derivatives of natural rubber latex were not used as materials in the manufacture of their medical product and container, FDA recommends the use of the statement "Not made with natural rubber latex." If this statement is made without any qualification, it would apply to the medical product, its container, and any packaging. In certain cases, statements regarding not made with natural rubber latex may be appropriate only for certain components. In this case a manufacturer may elect to make a statement that the specific component is not made with natural rubber latex. For example, if the particular presentation or part of the presentation (e.g., vial stopper or syringe) is not made with natural rubber latex, FDA recommends the statement "The vial stopper is not made with natural rubber latex."

These statements "Not made with natural rubber latex" and "The vial stopper is not made with natural rubber latex" communicate that natural rubber latex was not used as a material in the finished product or as a material in a specific component, respectively. At the same time, the statement does not make the unsupportable claim that the medical product is free of or does not contain natural rubber latex (i.e., materials or contamination), which may promote a false sense of safety to users who are allergic to natural rubber latex. Finally, use of a consistent scientifically supportable labeling statement will reduce confusion among FDA staff, medical product manufacturers, and medical product users.

Dynarex product labeling that currently includes statements such as latex free or does not contain latex will be updated as soon as possible to show the recommended labeling statement Not made with natural rubber latex.

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