1-888-DYNAREX (396-2739)
FAX: 1-845-365-8201
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.

Disclaimer: Dynarex will make every effort to inform our customers of any changes made to a specific product, catalog copy or marketing collateral material. Dynarex cannot be held responsible for these changes. Dynarex reserves the right to make changes to the technical specs, dimensions, look or any other product change at any time without prior notice except as required by the US FDA Code of Federal Regulations for changes made to medical devices, OTC drugs and other foreign government regulations. Please note:  All products on the Dynarex website may not be licensed in all countries. Customers are hereby directed to consult with their Customer Services Representative before placing a purchase order.

Product sizes may vary slightly based on production tolerances using the metric system and are stated for marketing purposes only.

Information provided about Dynarex advanced wound care products should be considered as general guidelines to product usage and none of the information is intended to be construed as medical advice. Medical conditions should be evaluated and treated by licensed practitioners. Please see your local wound care clinician for treatment of your wound.

Dynarex's Privacy Policy

10 Glenshaw Street, Orangeburg, NY 10962 1.888.DYNAREX
Copyright 2018 Corporation, All Rights Reserved