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In 1978 FDA published a tentative final monograph (TFM) for topical antimicrobial products. The record was re-opened in March 1979 to take into account six comments the agency received during the period for submitting objections to the TFM, including new data submitted by Procter & Gamble on the safety and effectiveness of triclocarban and by Ciba-Geigy on the proliferation of use of triclosan. The document states that, “significant amounts of new and previously unconsidered data were submitted with each of the above petitions.” [69] It was re-opened again in October of that year to permit interested persons to submit further data establishing conditions for the safety, effectiveness and labeling of over-the-counter topical antimicrobial products for human use.

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