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OTC inactive ingredients

This article was originally published in The Rose Sheet

Executive Summary

Listing should be confined to outer packaging, NDMA suggests in March 31 comments to FDA. The decision to use an OTC is "ordinarily made at point-of-purchase, therefore the [ingredient] listing generally should be visible at that point," the trade group said. The comments address a section in the FDA Modernization Act that requires OTC manufacturers to quantitatively list active ingredients and alphabetically list inactive ingredients on labels for products, including sunscreens, toothpaste and antidandruff shampoos. NDMA's comments also offer recommendations for small packages, suggesting a container less than 12 square inches should list inactives on accompanying labeling. Furthermore, in situations where it "may not be realistic to demand that the inactive ingredient listing be visible at the point-of-purchase," NDMA advises that accompanying labeling take the form of hang tags, inserts or tear-offs...
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