Do Warnings Apply to Condoms and Sexual Lubricants?
2. Are Condoms Lubricated With N9 Safe To Use? 3. How Do Warnings Apply to N9 Products Used With Barrier Methods? G. Is N9 Safe for Women at Low Risk for HIV/AIDS and STDs? H. Is N9 Safe for Rectal Use? I. Does N9 Increase the Risk of STDs Other Than HIV? J. What Issues Did Other Comments Discuss? 1. Why Did FDA Define Frequent Use of N9 as “More Than Once a Day”? 2. Should “Pharmacist” or “Health Care Provider” Be Included on the Label? 3. What Does “Unprotected Sex” Mean? 4. What Does the Word “Irritation” Mean When Referring To “Vaginal Irritation” in the Warning Language? 5. Should Warnings Be Printed in Both English and Spanish? III. FDA’s Final Conclusions on Warnings and Other Labeling Information for OTC Vaginal Contraceptive and Spermicide Drug Products Containing N9 A. New Labeling Requirements B. Statement About Warnings IV. Analysis of Impacts V. Paperwork Reduction Act of 1995 VI. Environmental Impact VII. Federalism VIII. References I. Background In the Federal Register o
