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U.S. Department of Health and Human Services

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OTC Panel Submissions (Indices Only): 02 - Antimicrobial I

Antimicrobial Data Submissions
Volume  # Color Company Product
1-8 Brown (or clear) Givuidan Corp. G-l (hexachlorophene)
9-13 Green Sterling Drug Inc. Zephiran Aqueous and Zobenol Aqueous
14 Green Sterling Drug Soapure and Sarene
15 Green Sterling Drug Mediquick
16 Geen Sterling Drug Roccal
17-18 Green Sterling Drug Benzalkonium Chloride
19-20 Green Sterling Drug Hexachlorophene
21 Green Sterling Drug Zephiran Tincture and Zobenol Tincture
22 Green Sterling Drug Campo-Phenique
23-28 Green Sterling Drug PhisoHex, Fisohex and Phiso Scrub
29 Green Sterling Drug Zephiran Towellettes
30 Black Chesebrough-Ponds Inc. Vaseline First Aid Carbolate Petrolium Jelly
31 Grey Monsanto Trichlocarban in bar soap
32 Blue R. Schatttner Co. Phenolic Compounds Oraderm lip Lotion Chloraderm Liquid
33-40 Black Ciba-Geigy Irgasan DP-300
41-43 Brown Norwich  Pharmacal Unguentine
44-46 Black Armour Dial Inc. Hexachlorophene and Trichlocarban
47 Red

Vestal Labs

 Dis Chemical Corp

 Septisol
48 Red (or Blue) Fine Organics Inc. Temasept (Tribromsalan)
49 Grey Campana Corp. Cuticura Medicated Soap
50 Grey Rilox Co. Geneva  Ointment
51 Black Colgate Palmolive Wash’n Dri Washkins for Babies
52 Black Colgate Palmolive Washkins (hospital pack)
53 Black Colgate Palmolive Wash’n Dri (professinal)
54 Black Colgate Palmolive Dermassage Lotion
55 Black Colgate Palmolive Tackel Gel
56 Black Armour Dial Tribromsalan
57 Black Smith, Kline and French Pragmatar
58 Black Smith, Kline and French Acnomel Cream, Cake
59 Blue Nitine Inc. Nitex
60 Clear

Oxford  Chemicals

Disconsolidated Food Corp

 Hexachlorophene
61 Brown Anti-infective Literature Search FDA Library
62 Brown Ayerst Laboratories Dermoplast Aerosol
63 Clear Defense Med. Purchase Descriptions Detergent, Providone, Iodine
64 Brown U.S.   Borax MD-7, Tomac, Luron
65-66 Brown Miscellaneous Submissions  
67 Brown Ferro Corp. Ottasept
68 Tan Phenix Phenix Fungicide
69-70 Blue Armour Dial Hexachlorophene
71 Red West Chemical Iodophors
72 Brown Chesebrough Ponds Inc. Virac Topical Germacide
73 Tan R.T. Vanderbilt Vancide
74-76 Brown Plough Inc. Solarcaine
77-79 Brown Plough Inc. Maxana Medicated Powder
80-82 Blue Merck, Sharp & Dohme ST 37 Antiseptic
83 Black Proctor and Gamble Safeguard
84 Brown C.R. Canfield & Co. Sebacide
85 Tan High Chemical Company Klorlyptus
86 Blue Merck, Sharp & Dohme Approve
87-91 Black (looseleaf) Miles Labs Bactine
92 Clear C.R. Canfield Sebacide
93 Black UpJohn Co. Mercresin
94 Brown Plough, Inc. Clean’n Treat
95 Clear Marika Verdi Lotion
96 Clear Armour Dial Dial and Safeguard Supp.
97 Clear Sterling Drug PhisoHex
98 Brown Purdue Frederick Betadine Cleanser
99 Brown Purdue Frederick Betadine Antiseptic
100 Brown Purdue Frederick Betadine Aerosol Spray
101 Brown Purdue Frederick Betadine Ointment
162 Brown Sterling DRUG Tribromosalicylanilide
103 Brown Armour Dial, Inc. Hexachlorophene
104 Brown CIBA-GEIGY

Irgasan DP 300

Triclosan
105 Brown Pfister Tribromosalicylanilide
106 Brown FDA Literature Search Supplement #1

Dichloro-m-Xylenol

O-Phenyl-Phenol

Pyrithione Zinc
107 Blue Lever Brothers Tribromsalan
108-113 Red or Yellow Lever Brothers Tribromsalan
114

Yellow

(3 copies only)

1.  Mrs. Bruch

2.  Dr. Epstein

3.  Dr. Kinoshita

 Lever Brothers Tribromsalan
115 Blue FDA Literature Search Supplement #2 Quaternary Ammonium Compounds
116 Clear Ciba Geigy Irgasan DP-300
117 Black Colgate P-300 Soap Bar
118 Black Colgate P-300 Soap Bar
119 Blue Purdue Frederick Betadine Providone-iodine
120 Black Sherwin Williams Tribromosalicylanilide
121 Blue Merck, Sharp & Dohme (   IND # 6355) 5-Chloro-2 (2.4 Dichloro-Phenoxy) Phenol
122 Yellow or Red Lever Brothers Tribromsalan
123 Black Armour Dial Inc. Triclocarban Summary Report
124 Black Armour Dial Inc. Triclocarban Raw Data
125     3 Volumes combined in one
126 Brown Armour Dial Inc. Jacket (except Dr. Kinoshita’s)
127 Brown Armour Dial Inc. Triclocarbon
128 Black Parke Davis Benzethonium Chloride (Phemerol)
129 Clear Smith, Kline & French Pragmator (Labeling Change)
130 Clear FDA FDA Health Practices and Opinions Study
131 Yellow West Chemical Ionol (BHT)
132 Yellow Fine Organics Inc. TBS
133 Clear or Clear Proctor & Gamble

1972-73 Antibacterial animal studies

Preliminary Report TCC, TFC, BSA, HCP
134 Green Sterling Drug Zephiran Cl.
135 Gray Norwich  Pharmacal Unquentine
136 Blue Sterling Drug Tribromo Salicylanilide
137 Blue Sterling Drug Tribromo Salicylanilide
138 Green FDA Literature Search Supplement #2 (abstracts) Quaternary Ammonium Compound
139 Brown Procter & Gamble 91 Day, Rat Feeding Study with HCl, TBS, TCC, TFC
140 Gray West Chemical Iodophors
141 Gray lCl   America Hibitane (chlorhexidine Gluconate) submission dated 10-13-72 to BD-120
142 Black CIBA-GEIGY Irgasan DP-300
143 Gray Sterling Drug Methylbenzethonium chloride
144 Red FDA Article on “Triple Dyd” (Dr. Lockhart)
145 Gray Chesebrough Pond, Inc. Addendum to VIRAC
146 Black Rystan Sodium Propioxiate Chlorophyll
147 Gray R. Schattner Company (Prophyllin) Chloraderm (invivo data)
148 Yellow Procter & Gamble Company 28 Day Rabbitt Study HCP, BSA, TCC, TFC
149 Yellow Jerry M. Rice, Ph.D Ncl Letter to Dr. Francis Margulli, FDA Toxicity & Carcinogenicity of PVP
150 Yellow Peter S. Herman, MBBS, MSC, CSPR;   University of Sherbrooke  Quebec , Canada Letter to Mary Bruch Executive Secretary, OTC Panel
151 Yellow Sterling Drug Inc. Individual Brain Weights of rats TBS Study
152 Yellow Chesebrough Ponds, Inc. Virac Supplemental Information (New PDR Section)
153 Black Ciba-Geigy Corp. Irgasan CF3 Cloflucarban Additional Safety Data
154 Black Ciba-Geigy Corp. Iragasan CF3 Cloflucarban Additional  Safety Data
155 Yellow Colgate-Palmolive Company Letter to Panel Chairman re: TBS
156 Various Colors Ferro Corp. Additional test data on Otrasept
157 Red West Chemical Additional data on Iodophors
158 Blue FDA Cross Index to Submission
159 Clear (and Blue) The Purdue Frederick Co. Additional Data on Betadine
160 Clear

Ferro Corp.

Ottawa  Chemical Div.

 Additional Data on p-chloro-xylenol
161 Red West Chemical Products Inc. Additional Data on Iodophors
162 Brown Huntington Laboratories Inc. Iodophors
163 Brown Sterling Drug Inc. Additional Data on TBS
164 Yellow Letters from various dermatologists re: TBS
165 Brown Monsanto TCC
166 Black Ciba-Geigy Corp. Iragasan (CF 3) Additional Data
167 Black Ciba-Geigy Corp. Iragasan (DP 300) Additional Data
168 Black Ciba-Geigy Corp. Iragasan (DP 300) Additional Data
169 Red Lever Brothers Co.

TBS

Additional Data
170 Blue Lever Brothers Co. Irgasan (DP 300)
171 Yellow Winthrop  Laboratories Comments on Proposed Definitions and Guidelines
172 Brown Fine Organics TBS Additional Data (Summary)
173 Clear Fine Organics TBS Additional Data
174 Blue Sterling Phisohex-Final Report Infant Monkey Study
175 Black Chesebrough-Ponds, Inc. Additional Data; Vasoline Carbolated Petroleum Jelly
176 Blue

W. Mitchel Sams, Jr., M.D.

Prof. And Head

Division of Dermatology

University of   Colorado  Med.  Center

Denver,  Colorado

 Letter regarding TBS
177 Blue West Chemical Products, Inc. Comments on Panels Proposed Definitions
178   FDA Misc. Reports (Proctor and Gamble NDA)
179  

Onyx Chemical Company

Jersey City,  NJ  07302

 Toxicity data on Quaternary Ammonium Compounds
180 Yellow Colgate-Palmolive Additional data on Dermassage - Comments on Oxyquinoline Sulfate as an active ingredient
181 Red West Chemical Products, Inc. Iodine Bibliography
182 Black Colgate-Palmolive Additional animal safety data on Irgasan, HCP & TBS
183 Black Colgate-Palmolive  
184 Black Colgate-Palmolive  
185 Black Colgate-Palmolive  
186     Misc. FDA Reports
187   Fine Organics 90 Day Subacute Rat Study on TBS
188   Bristal-Myers Co. Presentation on Skin Antiseptics
189   Monsanto TCC Reproduction Study
190   FDA Additional data on Phenol
191   FDA Misc. Uncited Ref.

Topical Antimicrobial Drug Products for OTC Human Use Establishment of a Monograph and Reopening of Administrative Record
Docket No. 75N-0183 

Volume
02APA1 

In the FEDERAL REGISTER of September 7, 1982 (47 FR 39406), the administrative record for the OTC topical antimicrobial drug products rulemaking was reopened to include a statement on OTC Drug Products for the Treatment of Diaper Rash by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for that statement appears as part of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412). 

The material included in the topical antifungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.

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