Docket Management
Docket: 80N-0280 - Over-the-Counter Vaginal Contraceptive Drug Products Containing Nonoxynol 9; Required Labeling
Comment Number: EC -103

Accepted - Volume 14

Comment Record
Commentor Mrs. Marianne Marlow Date/Time 2003-02-19 09:30:44
Organization Winnebago County Health Dept
Category Health Professional

Comments for FDA General
1. General Comments For several our HIV/STD Counselors have been discouraging clients from using any product containing Nonoxynol-9 because there has been evidence that excessive use of Nonoxynol-9 causes vaginal irritation which may make a person more likely to contract HIV and other STD's if they come in contact with someone who is infected. We have been distributing condoms without the Nonoxynol-9, along with the condoms we have been including other lubricants such as K-Y because studies have shown that extra lubricant helps keep the condom from breaking which is what is necessary to prevent HIV. I personally believe that Nonoxynol-9 still helps prevent pregnancey when combined with a condom or a diaphraghm and therefore should remain on the market for those individuals who use these methods to prevent pregnancy. The warning on the label for Nonoxynol-9 should probably read that if used excessively ie; several times a day, that it's use could cause vaginal and penile irritation. PS: I have been working in this field for 23 years.

EC -103