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Interchangeability reg

This article was originally published in The Tan Sheet

Executive Summary

J&J unit Advanced Care Products urges in a June 4 letter to FDA that the interchangeability of terms in OTC product labeling such as "doctor" and "physician" be expanded to the phrase "consult (ask) your doctor (physician) or pharmacist." Advanced Care, which markets Monistat-7, noted that including "pharmacist" is appropriate because "these are OTC products" and pharmacists are generally more available to the consumer than doctors. The firm also suggested that FDA allow the interchangeability of "assistance" and "help" in the warning: "in case of accidental ingestion, seek professional assistance or contact a poison control center immediately." FDA proposed allowing the interchangeability of terms in OTC labeling in a recent notice ("The Tan Sheet" April 5, p. 9).

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