The FDA proposed that certain ingredients in over-the-counter (OTC) drug products are not generally recognized as safe and effective (GRASE) or are misbranded. The FDA issued the proposed rule because it did not receive any data on these ingredients in response to a request on December 31, 2003 (68 Federal Register 75585). The FDA noted that the names of several active ingredients changed from the way they appeared in the December 31, 2003 Federal Register notice. Based on submissions received from the 2003 notice, certain products including: lubricants and vaginal moisturizers, nasal moisturizers, urinary/analgesics/antiseptics, wrinkle removers, lanolin for use as a nipple protectant, and ichthammol for use in drawing salves, were not included in the proposed rule.
SOURCE: FDA Proposal
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