id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
FDA-2016-N-0124-0413,FDA,FDA-2016-N-0124,FINAL Third Extension Deferral Letter,Other,Letter(s),2022-05-31T04:00:00Z,2022,5,2022-05-31T04:00:00Z,,2022-05-31T14:54:57Z,,0,0,0900006483e57838
FDA-2016-N-0124-0410,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small
Entity Compliance Guide; Availability",Notice,Notice of Availability,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2020-12-31T14:14:51Z,2020-28929,0,0,09000064849d654d
FDA-2016-N-0124-0411,FDA,FDA-2016-N-0124,"Consumer Antiseptic Rub Final Rule; Finding of Ineligibility for Inclusion in Final Monograph Questions and Answers; Guidance for Industry; Small
Entity Compliance Guide; Availability",Other,Guidance,2020-12-31T05:00:00Z,2020,12,2020-12-31T05:00:00Z,,2024-11-12T23:26:51Z,,1,0,09000064849d6159
FDA-2016-N-0124-0409,FDA,FDA-2016-N-0124,The American CIeaning Institute Progress Report,Other,Report,2020-12-04T05:00:00Z,2020,12,2020-12-04T05:00:00Z,,2020-12-04T16:13:10Z,,0,0,0900006484986dd5
FDA-2016-N-0124-0408,FDA,FDA-2016-N-0124,FDA Updated Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi),Other,Letter(s),2020-11-23T05:00:00Z,2020,11,2020-11-23T05:00:00Z,,2020-11-23T13:08:25Z,,0,0,0900006484970496
FDA-2016-N-0124-0407,FDA,FDA-2016-N-0124,FDA Response to ACI July 2020 Progress Report (ethanol bzk pmcx bzec pi),Other,Agency Response,2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2020-11-20T14:38:40Z,,0,0,090000648496ca62
FDA-2016-N-0124-0406,FDA,FDA-2016-N-0124,ACI Advice November 18 2020,Other,Letter(s),2020-11-20T05:00:00Z,2020,11,2020-11-20T05:00:00Z,,2020-11-20T14:34:16Z,,0,0,090000648496ca5c
FDA-2016-N-0124-0405,FDA,FDA-2016-N-0124,ACI BZT Monograph Meeting Minutes Written Responses,Supporting & Related Material,Meeting Materials,2020-10-06T04:00:00Z,2020,10,,,2020-10-06T14:59:41Z,,0,0,09000064848de180
FDA-2016-N-0124-0404,FDA,FDA-2016-N-0124,Meeting Minutes for Lonza & Henkel’s benzalkonium chloride consumer antiseptic hand wash July 30 2020,Other,Minutes,2020-08-26T04:00:00Z,2020,8,2020-08-26T04:00:00Z,,2020-08-26T13:56:29Z,,0,0,09000064848202dd
FDA-2016-N-0124-0395,FDA,FDA-2016-N-0124,Lonza Inc. Data Listing 16.2.7.1: Adverse Events Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:09:31Z,,0,0,0900006484719149
FDA-2016-N-0124-0389,FDA,FDA-2016-N-0124,"Lonza, Inc. and Henkel Corporation, Inc. Signatures of Authors, Principal Investigator, and Sponsor's Medical Officer re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:51:09Z,,0,0,0900006484719143
FDA-2016-N-0124-0403,FDA,FDA-2016-N-0124,Lonza Inc. Table 14.1.1: Summary of Subject Enrollment and Disposition re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:27:08Z,,0,0,0900006484719220
FDA-2016-N-0124-0393,FDA,FDA-2016-N-0124,"Lonza Inc. Listing 16.2.5.1: Plasma Concentration (ng/L) - C12 homologs
Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:04:49Z,,0,0,0900006484719147
FDA-2016-N-0124-0386,FDA,FDA-2016-N-0124,"Henkel Corporation, Inc. Lonza Inc. Case Report Form Booklet
Final Version # 1.0 November 04, 2019 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:42:31Z,,0,0,0900006484719140
FDA-2016-N-0124-0390,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.1 Subject Disposition and Population Inclusion All Enrolled Subjects (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:59:15Z,,0,0,0900006484719144
FDA-2016-N-0124-0399,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.11: Childbearing Potential and Urine Pregnancy Test Results All Female Subjects (N= 20) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:17:26Z,,0,0,090000648471921c
FDA-2016-N-0124-0402,FDA,FDA-2016-N-0124,"Lonza Inc. Figure 14.2.2.1: Individual Subject Plasma Levels, Linear for C12 and C14 homologs, PK Population Subject Number: 0001 at Day 1 re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:25:07Z,,0,0,090000648471921f
FDA-2016-N-0124-0400,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.12: Comments Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:19:32Z,,0,0,090000648471921d
FDA-2016-N-0124-0387,FDA,FDA-2016-N-0124,Lonza Inc. INFORMED CONSENT DOCUMENT AGREEMENT TO BE IN A RESEARCH STUDY re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:45:15Z,,0,0,0900006484719141
FDA-2016-N-0124-0385,FDA,FDA-2016-N-0124,"Henkel Corporation, Inc. Lonza Inc. A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:42:03Z,,0,0,0900006484718cdb
FDA-2016-N-0124-0391,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.2 Protocol Deviations Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:01:01Z,,0,0,0900006484719145
FDA-2016-N-0124-0396,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.8: Vital Signs Test Results Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:11:56Z,,0,0,0900006484719219
FDA-2016-N-0124-0398,FDA,FDA-2016-N-0124,"Lonza Inc. Listing 16.2.10.1: Laboratory Test Results, Chemistry, Part 1 Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:15:35Z,,0,0,090000648471921b
FDA-2016-N-0124-0397,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.9: Physical Examination Results - Abnormal Findings Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:13:50Z,,0,0,090000648471921a
FDA-2016-N-0124-0401,FDA,FDA-2016-N-0124,"Henkel Corporation, Inc. Lonza Inc.A Pilot Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin with Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:23:13Z,,0,0,090000648471921e
FDA-2016-N-0124-0394,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.6.1: Hand Wash and Packaging Weights Details Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:07:10Z,,0,0,0900006484719148
FDA-2016-N-0124-0384,FDA,FDA-2016-N-0124,Lonza Inc. A Pivotal Maximal Use Study to Measure the Systemic Absorption of Benzalkonium Chloride (BAC) after Exaggerated Use of the Antimicrobial Soap on Intact Skin in Healthy Volunteers re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:42:18Z,,0,0,0900006484718cd5
FDA-2016-N-0124-0392,FDA,FDA-2016-N-0124,Lonza Inc. Listing 16.2.4.1: Demographics and Baseline Characteristics Safety Population (N=42) re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T21:02:58Z,,0,0,0900006484719146
FDA-2016-N-0124-0388,FDA,FDA-2016-N-0124,Curriculum Vitaes re Safety and Effectiveness of Consumer Antiseptics: Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2020-06-29T04:00:00Z,2020,6,,,2020-06-29T20:48:34Z,,0,0,0900006484719142
FDA-2016-N-0124-0370,FDA,FDA-2016-N-0124,16-5-4-representative-chromatograms,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:34Z,,0,0,090000648470d5dd
FDA-2016-N-0124-0383,FDA,FDA-2016-N-0124,16-6-ba-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:37:09Z,,0,0,090000648470d617
FDA-2016-N-0124-0375,FDA,FDA-2016-N-0124,16-5-2-coas-of-reference-standards,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:30:08Z,,0,0,090000648470d52b
FDA-2016-N-0124-0361,FDA,FDA-2016-N-0124,Appendix 3_lonza_pmut_052019_csr,Supporting & Related Material,Background Material,2020-06-25T04:00:00Z,2020,6,,,2020-06-25T17:15:28Z,,0,0,090000648470bb28
FDA-2016-N-0124-0367,FDA,FDA-2016-N-0124,16-5-7-incurred-samples-reanalysis-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:05Z,,0,0,090000648470d5d1
FDA-2016-N-0124-0376,FDA,FDA-2016-N-0124,16-5-3-representative-chromatograms,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:31:05Z,,0,0,090000648470d52c
FDA-2016-N-0124-0369,FDA,FDA-2016-N-0124,16-5-5-result-tables-of-all-runs,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:24Z,,0,0,090000648470d5d5
FDA-2016-N-0124-0359,FDA,FDA-2016-N-0124,Appendix 1_Lonza FINAL July 3_2019 Prelim Meeting Preliminary Commt for July 2019 MTG,Supporting & Related Material,Background Material,2020-06-25T04:00:00Z,2020,6,,,2020-06-25T17:15:13Z,,0,0,090000648470bb2a
FDA-2016-N-0124-0378,FDA,FDA-2016-N-0124,16-5-5-Criteria-for-sample-reanalysis-and-reporting-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:32:46Z,,0,0,090000648470d2b0
FDA-2016-N-0124-0362,FDA,FDA-2016-N-0124,16-6-ba-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:21:06Z,,0,0,090000648470d1e6
FDA-2016-N-0124-0379,FDA,FDA-2016-N-0124,16-5-6-incurred-samples-reanalysis-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:33:33Z,,0,0,090000648470d2b6
FDA-2016-N-0124-0371,FDA,FDA-2016-N-0124,16-5-3-multianalyte-reanalysis-batches-data,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:43Z,,0,0,090000648470d5df
FDA-2016-N-0124-0372,FDA,FDA-2016-N-0124,16-5-2-coas-of-reference-standards,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:54Z,,0,0,090000648470d5e1
FDA-2016-N-0124-0364,FDA,FDA-2016-N-0124,16-6-2-ba-2nd-add-to-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:21:26Z,,0,0,090000648470d1ea
FDA-2016-N-0124-0374,FDA,FDA-2016-N-0124,16-5-1-preparation-acceptance-criteria-for-cc-qc-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:29:21Z,,0,0,090000648470d52a
FDA-2016-N-0124-0357,FDA,FDA-2016-N-0124,Briefing Document BAC June 2020_Final,Other,Memo,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T17:12:57Z,,0,0,090000648470c918
FDA-2016-N-0124-0368,FDA,FDA-2016-N-0124,16-5-6-Criteria-for-sample-reanalysis-and-reporting-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:22:15Z,,0,0,090000648470d5d3
FDA-2016-N-0124-0381,FDA,FDA-2016-N-0124,16-6-1-ba-1st-add-to-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:35:16Z,,0,0,090000648470d2b8
FDA-2016-N-0124-0373,FDA,FDA-2016-N-0124,16-5-1-preparation-acceptance-criteria-for-cc-qc-sop,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:23:04Z,,0,0,090000648470d5e3
FDA-2016-N-0124-0358,FDA,FDA-2016-N-0124,Lonza Study No_TKL MC000520 CSP Final v1.0 19June2020 - signed,Other,Studies,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T17:13:28Z,,0,0,090000648470c91a
FDA-2016-N-0124-0360,FDA,FDA-2016-N-0124,Appendix 2_BAC IVDP Foaming  Liquid Handwashes 06.2020 CRL FINAL Report,Supporting & Related Material,Background Material,2020-06-25T04:00:00Z,2020,6,,,2020-06-25T17:15:20Z,,0,0,090000648470bb29
FDA-2016-N-0124-0377,FDA,FDA-2016-N-0124,16-5-4-result-tables-of-all-runs,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:32:00Z,,0,0,090000648470d52d
FDA-2016-N-0124-0365,FDA,FDA-2016-N-0124,16-6-1-ba-1st-add-to-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:21:36Z,,0,0,090000648470d5cd
FDA-2016-N-0124-0380,FDA,FDA-2016-N-0124,16-5-bioanalyt-pmut-052019,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:34:23Z,,0,0,090000648470d2b7
FDA-2016-N-0124-0363,FDA,FDA-2016-N-0124,16-6-3-ba-3rd-add-to-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:21:15Z,,0,0,090000648470d1e8
FDA-2016-N-0124-0382,FDA,FDA-2016-N-0124,16-6-2-ba-2nd-add-to-validationreport,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:36:15Z,,0,0,090000648470d2b9
FDA-2016-N-0124-0366,FDA,FDA-2016-N-0124,16-5-bioanalyt-pmut-052019,Other,Report,2020-06-25T04:00:00Z,2020,6,2020-06-25T04:00:00Z,,2020-06-25T19:21:55Z,,0,0,090000648470d5cf
FDA-2016-N-0124-0356,FDA,FDA-2016-N-0124,MONOGRAPH Meeting Granted Letter Lonza and Henkel  2020 Benzalkonium Hand Soaps,Other,Request,2020-06-24T04:00:00Z,2020,6,2020-06-24T04:00:00Z,,2020-06-24T13:02:40Z,,0,0,0900006484704aad
FDA-2016-N-0124-0354,FDA,FDA-2016-N-0124,Request for Type C Meeting from Lewis and Harrison to FDA CDER/DNDP/ ODE IV,Other,Request,2020-03-13T04:00:00Z,2020,3,2020-03-13T04:00:00Z,,2020-03-13T20:20:10Z,,0,0,0900006484443e02
FDA-2016-N-0124-0353,FDA,FDA-2016-N-0124,FINAL Third Extension Deferral Letter from FDA CDER to American Cleaning Institute,Other,Letter(s),2019-10-17T04:00:00Z,2019,10,2019-10-17T04:00:00Z,,2019-10-17T15:39:32Z,,0,0,09000064840b4539
FDA-2016-N-0124-0352,FDA,FDA-2016-N-0124,Lonza FINAL July 3_2019 Prelim Meeting Preliminary Comment for July 2019 MTG (002),Other,Minutes,2019-09-19T04:00:00Z,2019,9,2019-09-19T04:00:00Z,,2019-09-19T18:24:21Z,,0,0,0900006483f9ee0c
FDA-2016-N-0124-0351,FDA,FDA-2016-N-0124,Letter from FDA CDER to American Cleaning Institute,Other,Letter(s),2019-08-09T04:00:00Z,2019,8,2019-08-09T04:00:00Z,,2019-08-09T12:57:05Z,,0,0,0900006483e1e09f
FDA-2016-N-0124-0350,FDA,FDA-2016-N-0124,Letter from FDA CDER to American Cleaning Institute,Other,Letter(s),2019-07-15T04:00:00Z,2019,7,2019-07-15T04:00:00Z,,2019-07-15T18:46:13Z,,0,0,0900006483d91e24
FDA-2016-N-0124-0349,FDA,FDA-2016-N-0124,LONZA Meeting Request for July 9 Cancelled,Other,Letter(s),2019-07-09T04:00:00Z,2019,7,2019-07-09T04:00:00Z,,2019-07-09T15:55:34Z,,0,0,0900006483d6f60a
FDA-2016-N-0124-0348,FDA,FDA-2016-N-0124,Letter from FDA CDER to Lewis & Harrison,Other,Letter(s),2019-06-12T04:00:00Z,2019,6,2019-06-12T04:00:00Z,,2019-09-19T16:52:24Z,,0,0,0900006483d09577
FDA-2016-N-0124-0307,FDA,FDA-2016-N-0124,"Reference 20 - Kolawole, D. O., Resistance Mechanisms of Mucoid-Grown Staphylococcus aureus to the Antibacterial Action of Some Disinfectants re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:42Z,,0,0,0900006483b6a60c
FDA-2016-N-0124-0318,FDA,FDA-2016-N-0124,"Reference 40 - Lanker Klossner, B., et al., Nondevelopment of Resistance by Bacteria During Hospital Use of Povidone-Iodine re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:52Z,,0,0,0900006483b6a95d
FDA-2016-N-0124-0294,FDA,FDA-2016-N-0124,Reference 2 – 6 – Volume_V_5_of_9_Published_Cited_References_Part_2_of_2_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:32Z,,0,0,0900006483b6a5f0
FDA-2016-N-0124-0325,FDA,FDA-2016-N-0124,"Reference 33 - Weber, D. J. and W. A. Rutala, Use of Germicides in the Home and the Healthcare re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:59Z,,0,0,0900006483b6a62c
FDA-2016-N-0124-0333,FDA,FDA-2016-N-0124,"Reference 49 - Copitch, J. L., et al., Prevalence of Decreased Susceptibility to Triclosan in Salmonella re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:59:07Z,,0,0,0900006483b6a63f
FDA-2016-N-0124-0344,FDA,FDA-2016-N-0124,"Reference 35 - Akinkunmi, E. O. and A. Lamikanra, Susceptibility of Community Associated Methicillin Resistant re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:48Z,,0,0,0900006483b6a62e
FDA-2016-N-0124-0297,FDA,FDA-2016-N-0124,Reference 2 – 3 – Volume_IV_3_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:34Z,,0,0,0900006483b6a4d3
FDA-2016-N-0124-0343,FDA,FDA-2016-N-0124,"Reference 36 - Kawamura-Sato, K., et al., Reduction of Disinfectant Bactericidal Activities in Clinically Isolated Acinetobacter species in the re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:48Z,,0,0,0900006483b6a959
FDA-2016-N-0124-0341,FDA,FDA-2016-N-0124,"Reference 41 - Oggioni, M. R., et al., Significant Differences Characterize the Correlation Coefficients Between Biocide and Antibiotic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:46Z,,0,0,0900006483b6a960
FDA-2016-N-0124-0312,FDA,FDA-2016-N-0124,"Reference 15 - Nagai, I. and H. Ogase, Absence of Role for Plasmids in Resistance to Multiple Disinfectants in Three re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:46Z,,0,0,0900006483b6a93b
FDA-2016-N-0124-0320,FDA,FDA-2016-N-0124,"Reference 38 - Khor, S. Y. and M. Jegathesan, In-Use testing of Disinfectants in Malaysian Government Hospitals re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:54Z,,0,0,0900006483b6a95b
FDA-2016-N-0124-0302,FDA,FDA-2016-N-0124,Reference.List.Consumer.Rub.Final.Rule.2019 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:38Z,,0,0,0900006483b6a46b
FDA-2016-N-0124-0300,FDA,FDA-2016-N-0124,Reference 2 - Comment submitted in Docket No. FDA-1975-N-0012-0081.  Volume_I_1_of_9_Soap_ and_Detergent_ re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:37Z,,0,0,0900006483b6a4cf
FDA-2016-N-0124-0332,FDA,FDA-2016-N-0124,"Reference 50 - FDA Deferral Letter for Benzalkonium Chloride in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:59:06Z,,0,0,0900006483b6a640
FDA-2016-N-0124-0310,FDA,FDA-2016-N-0124,"Reference 17 - Sakagami, Y. and K. Kajimura, Bactericidal Activities of Disinfectants against Vancomycin re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:45Z,,0,0,0900006483b6a93d
FDA-2016-N-0124-0345,FDA,FDA-2016-N-0124,"Reference 26 - Lacey, R. W., et al., Antiseptic Resistance in Methicillin-Resistant Staphylococcus aureus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:49Z,,0,0,0900006483b6a625
FDA-2016-N-0124-0347,FDA,FDA-2016-N-0124,"Reference 7 – 1 FDA Deferral Letter for Isopropyl Alcohol in Consumer Rub Antiseptics on October 31, 2017 re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:51Z,,0,0,0900006483b6a929
FDA-2016-N-0124-0309,FDA,FDA-2016-N-0124,"Reference 18 - Haley, C. E., et al., Bactericidal Activity of Antiseptics Against Methicillin-Resistant Staphylococcus re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:44Z,,0,0,0900006483b6a60a
FDA-2016-N-0124-0346,FDA,FDA-2016-N-0124,"Reference 25 - Kunisada, T., et al., Investigation on the Efficacy of Povidone-Iodine Against Antiseptic re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T19:00:50Z,,0,0,0900006483b6a613
FDA-2016-N-0124-0287,FDA,FDA-2016-N-0124,"Reference 4 -  Transcript of the October 20, 2005, Meeting of the Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:28Z,,0,0,0900006483b6a925
FDA-2016-N-0124-0321,FDA,FDA-2016-N-0124,"Reference 9 – Kramer, A., et. al., Quantity of Ethanol Absorption After Excessive Hand Disinfection Using Three Commercially re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:55Z,,0,0,0900006483b6a92c
FDA-2016-N-0124-0313,FDA,FDA-2016-N-0124,"Reference 14 - Czerwinski, S. E., et al., Novel Water-Based Antiseptic Lotion Demonstrates Rapid, Broad- Spectrum Kill Compared re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:47Z,,0,0,0900006483b6a93a
FDA-2016-N-0124-0292,FDA,FDA-2016-N-0124,Reference 2 – 8 – Volume_VII_7_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:31Z,,0,0,0900006483b6a5f5
FDA-2016-N-0124-0289,FDA,FDA-2016-N-0124,Reference 2 – 11 – Volume_IX_9_of_9_Publsihed_Cited_ References_Part_2_of_2_re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:29Z,,0,0,0900006483b6a5f8
FDA-2016-N-0124-0286,FDA,FDA-2016-N-0124,"Reference 5 - Summary Minutes of the November 14, 2008, Feedback Meeting with Personal  re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:27Z,,0,0,0900006483b6a926
FDA-2016-N-0124-0319,FDA,FDA-2016-N-0124,"Reference 39 - Rikimaru, T., et al., Bactericidal Activities of Commonly Used Antiseptics Against Multidrug-Resistant Mycobacterium re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:53Z,,0,0,0900006483b6a95c
FDA-2016-N-0124-0327,FDA,FDA-2016-N-0124,"Reference 31 - Noguchi, N., et al., Susceptibilities to Antiseptic Agents and Distribution of Antiseptic- Resistance Genes qacAB and smr re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:59:01Z,,0,0,0900006483b6a62a
FDA-2016-N-0124-0324,FDA,FDA-2016-N-0124,"Reference 34 - Rajamohan, G., et al., Biocide-Tolerant Multidrug-Resistant Acinetobacter baumannii Clinical Strains Are Associated with re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:58Z,,0,0,0900006483b6a62d
FDA-2016-N-0124-0329,FDA,FDA-2016-N-0124,"Reference 29 - Babaei, M et al Extremely re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:59:03Z,,0,0,0900006483b6a628
FDA-2016-N-0124-0311,FDA,FDA-2016-N-0124,"Reference 16 - Geraldo, I. M., et al., Rapid Antibacterial Activity of 2 Novel Hand Soaps re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:46Z,,0,0,0900006483b6a93c
FDA-2016-N-0124-0315,FDA,FDA-2016-N-0124,"Reference 12 - Food and Drug Administration, Guidance for Industry. M3(R2) Nonclinical Safety Studies for the Conduct of re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:49Z,,0,0,0900006483b6a938
FDA-2016-N-0124-0293,FDA,FDA-2016-N-0124,Reference 2 – 7 – Volume_VI_6_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:32Z,,0,0,0900006483b6a5f4
FDA-2016-N-0124-0290,FDA,FDA-2016-N-0124,Reference 2 – 10 – Volume_IX_9_of_9_References_Continuation_ re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:29Z,,0,0,0900006483b6a5f7
FDA-2016-N-0124-0298,FDA,FDA-2016-N-0124,Reference 2 – 2 – Volume_III_3_of_9_Reference_List_re_ Comment_ Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:35Z,,0,0,0900006483b6a4d1
FDA-2016-N-0124-0291,FDA,FDA-2016-N-0124,Reference 2 – 9 – Volume_VIII_8_of_9_References_Continuation_ re_ Comment_Soap_Detergent_ Association_ (SDA) re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use,Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:30Z,,0,0,0900006483b6a5f6
FDA-2016-N-0124-0288,FDA,FDA-2016-N-0124,"Reference 3 - Transcript of the March 23, 2005, Nonprescription Drugs Advisory Committee re Safety and Effectiveness of Consumer Antiseptic Rubs; Topical Antimicrobial Drug Products for Over-the-Counter Human Use",Supporting & Related Material,Background Material,2019-06-05T04:00:00Z,2019,6,,,2019-06-05T18:58:28Z,,0,0,0900006483b6a5f9