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Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule.
Fed Regist. 2007 Dec 19; 72(243):71769-85.FR

Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention.

Authors

No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18159651

Citation

Food and Drug Administration, HHS. "Over-the-counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling. Final Rule." Federal Register, vol. 72, no. 243, 2007, pp. 71769-85.
Food and Drug Administration, HHS. Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule. Fed Regist. 2007;72(243):71769-85.
Food and Drug Administration, HHS. (2007). Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule. Federal Register, 72(243), 71769-85.
Food and Drug Administration, HHS. Over-the-counter Vaginal Contraceptive and Spermicide Drug Products Containing Nonoxynol 9; Required Labeling. Final Rule. Fed Regist. 2007 Dec 19;72(243):71769-85. PubMed PMID: 18159651.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Over-the-counter vaginal contraceptive and spermicide drug products containing nonoxynol 9; required labeling. Final rule. A1 - ,, PY - 2007/12/28/pubmed PY - 2008/4/12/medline PY - 2007/12/28/entrez SP - 71769 EP - 85 JF - Federal register JO - Fed Regist VL - 72 IS - 243 N2 - The Food and Drug Administration (FDA) is issuing a final rule establishing new warning statements and other labeling information for all over-the-counter (OTC) vaginal contraceptive drug products (also known as spermicides, hereinafter referred to as vaginal contraceptives or vaginal contraceptives/spermicides) containing nonoxynol 9 (N9). These warning statements will advise consumers that vaginal contraceptives/spermicides containing N9 do not protect against infection from the human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS), or against getting other sexually transmitted diseases (STDs). The warnings and labeling information will also advise consumers that use of vaginal contraceptives and spermicides containing N9 can irritate the vagina and rectum and may increase the risk of getting the AIDS virus (HIV) from an infected partner. This final rule is part of FDA's ongoing review of OTC drug products. FDA is issuing this final rule after considering public comments on its proposed regulation, and all relevant data and information on N9 that have come to our attention. SN - 0097-6326 UR - https://www.unboundmedicine.com/medline/citation/18159651/Over_the_counter_vaginal_contraceptive_and_spermicide_drug_products_containing_nonoxynol_9 L2 - http://edocket.access.gpo.gov/2007/pdf/07-6111.pdf DB - PRIME DP - Unbound Medicine ER -