Regulatory Information
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OTC Panel Submissions (Indices Only): 13 - Oral Cavity
Public Administrative File
OTC Oral Health Care Drug Products
(Docket No. 81N-0033)
| VOLUME | SUBMITTED BY | TRADE NAME/ SUBJECT |
|---|---|---|
| 130001 | Monsanto | Methyl Salicylate |
| 130002 | Henry Thayer Co. |
Thayers Slippery Elm Throat lozenges |
| 130003 | Lorvic Corp. | Odara Solution |
| 130004 | Hoyt | Orabase with Benzocaine |
| 130005 | Cox Drugs | Formula “U” |
| 130006 |
Denver Chemical Manufacturing Co. |
Pain-A-Lay |
| 130007 | Merrell-National Laboratories | Cepacol Mouthwash/Gargle |
| 130008 | Merrell-National Laboratories | Cepacol Throat Lozenges |
|
130009 130010 130011 |
Merrell-National Laboratories | Cepacol Anesthetic Troches |
| 130012 | Endo laboratories, Inc. | Benocol |
| 130013 | Upjohn | Oral Pentacresol |
| 130014 | Endo Laboratories, Inc. | Lidocol |
| 130015 | Rystan Co., Inc. | Chloresium |
|
130016 130017 |
International Pharmaceutical Corp. | Gly-oxide Liquid |
| 130018 | Endo Laboratories, Inc. | Dyclocol |
|
130019 130020 130021 130022 130023 130024 |
Richardson-Merrell, Inc. |
Vicks Medi-Trating Lozenges Vicks Oracin Throat Lozenges |
| 130025 | Church and Dwight Co., Inc. | Arm and Hammer Baking Soda |
| 130026 | K.I.K. | Cheramist |
|
130027 130028 130029 |
Calgon Consumer Products Co., Inc. | Sucrets Cough Control Lozenge |
|
130030 130031 |
Calgon Consumer Products Co., Inc. | Sucrets Sore Throat Lozenge |
|
130032 130033 130034 130035 130036 |
Calgon Consumer Products Co., Inc. | Sucrets Cold Decongestant |
| 130037 | Block Drug Co., Inc. | Proxigel |
|
130038 130039 130040 |
Block Drug Co., Inc. | Chloraseptic |
| 130041 | Warren-Teed | Di-O-Chrome |
|
130042 130043 130044 130045 130046 130047 |
Warner-Lambert Co. | Listerine Antiseptic |
| 130048 | Cooper Laboratories, Inc. | Amosan |
|
130049 130050 |
Ciba-Geigy Corp. | Domiphen Bromide |
| 130051 | Ayerst laboratories | Larylgan Throat Spray |
| 130052 | Julius Schmid, Inc. | Comments |
|
130053 130054 130055 |
Johnson and Johnson | Micrin Plus Gargle and Rinse |
| 130056 | Purdue Frederick Co. | Betadine |
| 130057 | Blair Laboratories, Inc. | Isodine Concentrate |
| 130058 | E.R. Squibb and Sons, Inc. |
Spec-T Decongestant Lozenges Spec-T Cough Suppressant Spec-T Anesthetic Lozenges Spec-T Throat Spray |
| 130059 | Block Drug Co., Inc. | Anesthetic, Aqueous and Concentrate Mouthwash, and Aerosol Spray |
| 130060 | Scott Laboratories, Inc. | Scott’s Certified Peroxide of Hydrogen |
|
130061 130062 |
Merrell-National Laboratories | Anesthetic Gargle/Rinse/Spray |
|
130063 130064 130065 |
Block Drug Co., Inc. | Chloraseptic |
| 130066 | International Pharmaceutical Corp. | Gly-oxide Liquid |
|
130067 130068 130069 |
Merrell-National Laboratories |
Cepacol Mouthwash/Gargle Cepacol Lozenges Cepacol Troches Cepacol Discs |
| 130070 | E.R. Squibb and Sons, Inc. |
Spec-T Sore Throat/Decongestant Lozenge Spec-T Sore Throat/Cough Suppressant Lozenge Spec-T Sore Throat/Anesthetic Lozenge |
| 130071 | Cooper Laboratories, Inc. | Amosan |
| 130072 | Schmidt Laboratories | Comments |
| 130073 | McKesson Laboratories | Isodettes Throat Lozenges |
| 130074 | Warner-Lambert Co. | Listerine Throat Lozenges |
| 130075 | Hynson, Westcott, and Dunning, Inc. | Thantis Lozenges |
| 130076 | LaWall and Harrison Research laboratories, Inc. | Troutman’s Cough Syrup |
| 130077 | Reed and Carnrick Pharmaceuticals | Anesthetic Mouthwash |
| 130078 | Procter and Gamble Co. | Scope Mouthwash and Gargle |
|
130079 130080 |
Calgon Consumer Products Co., Inc. | Sucrets Sore Throat Lozenges |
| 130081 | Reed and Carnrick Pharmaceuticals | Anesthetic Mouthwash |
| 130082 | Anbesol | |
| 130083 | Reed and Carnrick Pharmaceuticals | Benzocaine Spray |
| 130084 | International Pharmaceutical Corp. | Gly-oxide Liquid |
| 130085 | Cooper Laboratories, Inc. | Oral-B Antiseptic Drops |
| 130086 | The Proprietary Association | Journal of Periodontal Research, Supplement No. 14, 1975 |
| 130087 | Sterling Drug, Inc. |
Campho-Phenique Liquid Campho-Phenique Powder |
| 130088 | Ryatan Co., Inc. |
Choresium - Data Supplement to Volume 130015 |
|
130089 130090 |
Merrell-National Laboratories | Cepacol - Addendum to Volume 130007 |
| 130091 | Bernard L. Oser Associates, Inc. | Statement Data to Volume 130042 |
| 130092 | Warner-Lambert Co. | Supplemental Data to Volume 130042 |
| 130093 | Cooper Laboratories, Inc.. | Supplemental Dat - “Actions of Oxygenating Agents on Oral Inflamations” |
| 130094 | Cooper Laboratories, Inc. | Supplement to Volume 130085 - Oral-B Antiseptic Drops |
| 130095 | Richardson-Merrell, Onc. | Vicks Throat Lozengers - Supplement to Volume 130019 |
| 130096 | Warner-Lambert Co. | Supplemental Data to Volume 130042 |
| 130097 |
Panelist Martin J. Goldberg, D.D.S. |
Three Papers from V. Periodontology, Volumes 45-46 |
| 130098 | Cooper Laboratories, Inc. | Amosan - Upadate of Data and Information to Volumes 130048, 130071, 130085, and 130093 |
| 130099 |
Industry Liaison Joseph D. Ambrozaitis, D.D.S., Ph. D. |
Bibliography: “A Review of mal Odor” |
|
130100 130101 |
Sterling Drug, Inc. | Campho-Phenique - Addendum to Volume 130087. |
| 130102 | Colgate-Palmolive Co. | Benzethonium Chloride Mouthrinse |
| 130103 | The Proprietary Association | Letter of June 26, 1976 and Position Paper - Rationale for Establishing Antiseptic Activity Mouthrinses |
| 130104 | Plough, Inc. | Aspergum |
| 130105 | Sterling Drug, Inc. | Campho- Phenique - Supplement to Volume 130087 |
| 130106 | Richardson-Merrell, Inc. | Cepacol Professional labeling for Mouthwash Gargle, Throat Lozenges, Anesthetic Troches |
| 130107 | Warner-Lambert Co. | Listerine - Supplement to Volume 130042 |
| 130108 | The Proprietary Association | Letter on Mouth-odors |
| 130109 | American Association of Poison Control Centers | Letter on Camphor |
| 130110-A | The Proprietary Association | Statement on Combining Multiple Ingredients |
| 130110-B | The Proprietary Association | Statement on the Evaluation of Mouthrinses |
| 130111 | Cooper Laboratories, Inc. | Amosan - Supplemental Information to Volumes 130048, 130071, 130085 and 130093 |
| 130112 | BASF Wyandotte Corp. | Pluronic Polyols - Toxicity and irritation Data |
| 130113 | Richardson-Merrell, Inc. | Metholated Cough Drops - Updating Information to Volume 130019 |
| 130114 | Richardson-Merrell, Inc. | Letter Relevant to the Panel’s In-vitro Guidelines for an Antiseptic/Antimicrobial Mouthwash |
| 130115 | Colgate-Palmolive Co. | Benzethonium Chloride - Supplemental Data to Volume 130102 |
| 130116 | Richardson-Merrell, Inc. | Oracin Throat Lozenges - Supplemental Data to Volume 130020 |
| 130117 | The Proprietary Association | OTC Oral Topical Antiseptics |
| 130118 | Procter and Gamble Co. | Addendum to Volume 130078 - Additional Data |
| 130119 | The Proprietary Association | OTC Combinations |
| 130120 | Colgate-Palmolive Co. | Benzethonium Chloride - Supplemental Data to Volume 130102 |
| 130121 | Warner-Lambert Co. | Addendum to Volume 130042 |
| 130122 | Richardson-Merrell, Inc. | Cepacol Concentrate - Labels for Dental Decanter and Gallon Bottle |
| 130123 | Cooper Laboratories, Inc. | Oral B Antiseptic Drops - Supplemental Information to Volume 130048 |
| 130124 | Richardson-Merrell, Inc. | Menthol - Additional Data to Volume 130019 |
| 130125 | Warner-Lambert Co. | Listerine - Additional Data to Volume 130042 |
| 130126 | Warner-Lambert Co. | Listerine - Additional Data to Volume 130042 |
| 130127 | Beecham Products | Dyclonine Lozenges |
| 130128 | Beecham Products | Dyclonine Lozenges |
| 130129 | Beecham Products | Dyclonine Lozenges |
| 130130-A | Beecham Products | Dyclonine Lozenges |
| 130130-B | Beecham Products | Dyclonine Lozenges |
| 130131 | Chloraseptic Products - Additional Data to Volume 130038 | |
| 130132 | The Proprietary Association | The Effectiveness of Locally Applied Topical Anesthetics |
| 130133 | The Proprietary Association | Guidelines for the Evaluation of Mouthwashes for the Reduction of Intrinsic Oral Malodor |
| 130134 | Procter and Gamble Co. | Cetylpyridinium Chloride and Domiphen Bromide Data |
| 130135 | Warner-Lambert Co. | Listerine Antiseptic |
| 130136 | Warner-Lambert Co. | Listerine Antiseptic |
| 130137 | Warner-Lambert Co. | Listerine Antiseptic |
| 130138 | Merrell-National Laboratories | Cepacol Mouthwash/Gargle |
| 130139 | Cooper Laboratories, Inc. | Amosan |
| 130140 | Warner-Lambert Co. | Listerine Antiseptic - Volatile Oils/Topical |
| 130141 | The Proprietary Association | In-vitro Evaluation of Antimicrobial Mouthrinses |
| 130142 | The Proprietary Association | In-vitro Evaluation of Antimicrobial Mouthrinses - Volumes 1,2, and 3 - Comments to the panel’s Draft Report |
| 130143 | Beecham Products | Sore throat Product Labeling |
| 130144 | Lever Brothers Co. | In-vitro Antimicrobial Testing Guidelines |
| 130145 | Oral Products Hedonics | “Bad Breath” |
| 130146 | Richardson-Merrell, Inc. | Oracin Throat Lozenges |
| 130147 | Ralph B. D’Agostino | Statistical Evaluation of Studies on Cepacol and Scope |
| 130148 | Ralph B. D’Agostino | Statistical Analysis of Listerine Antiseptic |
| 130149 | Division of Medical Sciences, National Research Council/National Academy of Sciences | Drug Efficacy Study |
| 130150 | Merrell-National Laboratories | Effects of Local Anesthetics on Tactile Sensitivity Thresholds for Cutaneous and Mucous Membranes |
| 130151 | Merrell-National Laboratories | Cetylpyridinium Chloride/Sodium Fluoride Solution |
| 130152 | Cooper Laboratories, Inc. | Amosan |
| 130153 | Guidelines for Testing the Effectiveness of Locally Applied Topical Antiseptics Other Than Mouthrinses | |
| 130154 | Hynson, Wescott, and Dunning, Inc. | Thantis Lozenges (was 170040) |
| 130155 |
Panelist Arthur N. Bahn, Ph.D. |
The Efficacy of Mouthwashes |
| 130156 | Warner-Lambert Co. | Listerine |
| 130157 | Cooper Laboratories, Inc. | Amosan |
| 130158 | Cooper Laboratories, Inc. | Amosan |
| 130159 | Cooper Laboratories, Inc. | “Absorption of Boron after Mouthwash Treatment with Bocosept” |
| 130160 | Procter and Gamble Co. | Active Ingedients in Scope - Cetylpyridinium Chloride and Domiphen Bromide |
| 130161 | Procter and Gamble Co. | Information Provided to Dr. D’Agostino for Statistical Evaluation |
| 130162 | The Proprietary Association | Information Pertaining to a Presentation by the Proprietary Association to the Panel |
| 130163 | The Proprietary Association | Effectiveness of Locally Applied Topical Antiseptics |
| 130164 | Warner-Lambert Co. | Listerine Antiseptic - Drug vs Cosmetic Claims/Comment on Draft Report |
| 130165 | Merrell-National Laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130166 | Merrell-National Laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130167 | Merrell-National Laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130168 | Merrell-National Laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130169 | Merrell-National Laboratories | Safety and Effetiveness of Cetylpyridinium Chloride |
| 130170 | Merrell-National laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130171 | Merrell-National Laboratories | Safety and Effectiveness of Cetylpyridinium Chloride |
| 130172 | Warner-Lambert Co. | Relationship between Plaque, Bacteria, and Oral Disease |
| 130173 |
Walter J. Loesche, D.M.D., Ph. D |
In-vitro and In-vivo Testing of Antiseptic Mouthrinses |
| 130174 | Procter and Gamble Co. | Dental Plaque - Gingivitis and Dental Caries |
| 130175 | Forsyth Dental Center | Methods for Measuring Plaque |
| 130176 | Purdue Frederick Co. | Povidone-Iodine |
| 130177 | Whitehall Laboratories, Inc. | Anbesol |
| 130178 | Louis P. Gangerosa, Sr., D.D.S. | Comments |
| 130179 | Warner-Lambert Co. | Listerine |
| 130180 | Plough, Inc. | Topical Analgesics (Asprin) and Sore Throat |
| 130181 | Nathaniel H. Rowe, D.D.S. | Comments - Dental Plaque |
| 130182 | The Proprietary Association | Soft Tissue Responses to High Frequency Use of Experimental and Commercial Mouthwashes |
| 130183 | Purdue Frederick Co. | Providone-Iodine - Testing |
| 130184 |
Panelist Arthur N. Bahn, Ph. D. |
Minority Report, OTC advisory Panel on OTC oral Cavity Drug Products |
| 130185 | Irwin D. Mandel, D.D.S. | Plaque and Dental Disease |
| 130186 | Cooper Laboratories, Inc. | Amosan |
| 130187 | Procter and Gamble Co. | Domiphen Bromide Alone and in Combination with Cetylpyridinium Chloride |
| 130188 | The Proprietary association | Comments on the Information Copy of the panel’s Report |
| 130189 |
Panelist Walter E. Loch, M.D. |
Comments on Monograph |
| 130190 | The Proprietary Association | Comments on “Methods of Expressing Strength of Drugs” |
| 130191 | University Faculty Members | Comments on Plague, Gingivitis, or Microbial Activity in the Mouth as Related to OTC Mouthwashes |
| 130192 | Panel Chairman Lawrences Cohen, Ph. D., M.D., D.D.S. | Statement to the OTC Panel |
| 130193 | D. B. Smith, D.D.S. | Clarification of Data in his Paper on Mouthwashs and Oral Cancer |
Public Administrative File
OTC Oral Health Care Drug Products
(Docket No. 81N-0033)
Alphabetical Listing of References Cited in the Report
| VOLUME | CONTENTS |
|---|---|
| 130194 | A |
| 130195 | B |
| 130196 | C |
| 130197 | D-E |
| 130198 | F-G |
| 130199 | H-J |
| 130200 | K-L |
| 130201 | M-N |
| 130202 | O-R |
| 130203 | S |
| 130204 | T-Z |
| 130205 | Miscellaneous Uncited References A-G |
| 130206 | Miscellaneous Uncited references H-Z |
Public Administrative File
OTC Oral Health Care Drug Products
(Docket No. 81N-0033)
Panel Administrator’s File
| VOLUME | CONTENTS |
|---|---|
| 130PA1 |
Panel Administrator’s File Volume I - General 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Memebrs and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions |
| 130PA2 |
Panel Administrator’s File, Volume II - Minutes of Panel Meetings |
| 130PA3 |
Panel Administrator’s File, Volume III - Correspondence File (1973-1982). |
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