Americans expect and deserve consistent healthcare product labeling, no matter what state they buy or use the items in. It is in every citizen's best interest for the federal government to retain authority over safety labeling standards. Centralized regulation removes variability and guarantees the reliability of health data listed on consumer product packaging from coast to coast.
Request for agency exercise of enforcement discretion regarding the addition of new Warning language to Drug Facts labeling for Over-the-Counter benzocaine liquid/gel products indicated for relieving oral discomfort.
FDA Announcement of a proposed safety-based Administrative Order that proposes to add a skin allergy warning to labeling requirements for acetaminophen-containing drug products.
Members of the Consumer Healthcare Products Association who market dietary supplements containing St. John's wort initiated a voluntary labeling program on April 2, 2000.
The advertising of nonprescription, over-the-counter medicines helps acquaint the public with these products and must be truthful, not misleading, and must meet high standards reflecting the nature of the product advertised.
Safe use of acetaminophen is a top priority for manufacturers of OTC medicines. Manufacturers work closely with FDA, healthcare provider groups, pharmacist groups, and consumer health advocates to drive safe and responsible use of acetaminophen.
This proposed safety administrative order addresses the GRASE status of OTC oral health care drug products containing benzocaine alone or with phenol preparations labeled for anesthetic/analgesic indications (21 CFR 356).
