Regulatory Information
OTC - Panel Submissions (Indices Only): 08 - Dentifrices and Dental Care Agents
OTC Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
| Volume | Company | Products |
|---|---|---|
|
080015 080016 |
International Pharmaceutical Corp. | Gly-Oxide Liquid |
| 080043 | Rystan Co., Inc. | Chloresium Toothpaste, Dental Ointment, Solution |
| 080050 | Carter Products | Hydrogen Peroxide |
| 080063 | A-Trol Laboratories | I.D. Denture Medication |
| 080071 | McKesson Laboratories | Ora-Fix |
| 080072 | McKesson Laboratories | Documented Case Reports |
| 080094 | International Pharmaceutical Corp. | Gly-Oxide Liquid Additional Data |
| 080132 | Carter Products | Aerodent Green IV Dentifride |
| 080134B | International Pharmaceutical Corp. | Gly-Oxide Liquid Additional Data |
| 080140 | Cooper Laboratories, Inc. | Amosan |
|
080144 080145 |
Warner-Lambert | Listerine |
| 080147 | Church & Dwight Co., Inc. | Sodium Bicarbonate |
| 080156 | Carter Products |
Green IV Additional Data |
| 080168 | Rystan Co., Inc. |
Chloresium Toothpaste, Dental Ointment, and Solution Additonal Data |
| 080175 | Cooper Lanboratories, Inc. |
Amosan Additional Data |
| 080181 | International Pharmaceutical Corp. |
Gly-Oxide Liquid Additional Data |
| 080184 | International Pharmaceutical Corp. |
Gly-Oxide Liquid Additional Data |
| 080189 | International Pharmaceutical Corp. |
Gly-Oxide Liquid Additional Data |
| 080190 | Merrell-National Laboratories | Cepacol Mouthwash |
| 080219 | Carter Products |
Green IV Additional Data |
| 080220 | Cooper Laboratories Inc. |
Amosan Additional Data |
| 080244 | Church & Dwight Co., Inc. |
Sodium Bicarbonate Additional Data |
| 080247 | Cooper Laboratories, Inc. |
Amosan Additional Data |
Public Administrative File
OTC Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
General Dental Submissions
| VOLUME | SOURCE | REMARKS |
|---|---|---|
| 080058 | FDA |
NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) |
| 080059 | FDA | Cross Index to Data Submission. |
| 080061 | FDA | 35th and 36th Editions of “Accepted Dental Therapeutics” - Furnished at Panel’s Request. |
| 080064 | FDA |
OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
| 080065 | FDA |
OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium F. Fluoride, General |
| 080066 | FDA |
OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
| 080067 | FDA |
OTC Drug Literature Program X. Dentifrices Part-III (L-O) L. Sodium Monofluorophosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
| 080106 | FDA |
Color Additive Regulations-1974 (Requested by Panel). |
| 080236 | FDA | Labels from All Submissions. |
Public Administrative File
OTC Oral Mucosal Injury Drug Products
(Docket No. 78N-0196)
Alphabetical Listing of
References Cited in Report
| VOLUME | CONTENTS |
|---|---|
| 080262 | A-H |
| 080263 | I-R |
| 080264 | S-Z |
| 080265 | Miscellaneous Uncited References |
Public Administrative File
>OTC Oral Mucosal Injury Drug Products
> (Docket No. 78N-0196)
>Panel Administrator’s File
| VOLUME | CONTENTS |
|---|---|
| 080PA1 |
Panel Administrator’s File (Correspondence File), Volume 1 Contents 1.0 Table of Contents 1.1 Calls for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae for Panel Members 1.4 General and Specific Charges 1.5 List of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Report |
| 080PA2 |
Panel Administrator’a File (Correspondence File), Volume II, Meeting Summary Minutes. |
| 080PA3 |
Panel Administrator’s File (Correspondence File), Volume III (1973-1978). |
Public Administrator’s File
OTC Anticaries Drug Products
Docket No. 80N-0042
| VOLUME | SUBMITTED BY | TRADE NAME/SUBJECT |
|---|---|---|
| 080007 | Whitehall Labs, Inc. |
Super-white Kolynos Toothpaste |
| 080008 | The Lorvic Corp. |
Coral II Phosphate, Fluoride Prophylaxis Paste |
| 080011 | The Lorvic Corp. |
Karidium Phosphate Fluoride Topical Gel |
| 080012 | The Lorvic Corp. |
Karidium Phosphate Fluoride Topical Solution |
|
080018 080019 |
Lever Brothers |
Aim Stannous Fluoride Toothpaste |
| 080022 | Proctor & Gamble Co. | Gleen II Toothpaste |
| 080023 | Proctor & Gamble Co. | Crest Toothpaste |
| 080030 | Sterling Drug Co. | Caroid Tooth Powder |
| 080031 | Sterling Drug Co. | Phillips Toothpaste |
|
080040 080041 |
Beecham Products | McLeans Toothpaste |
| 080043 | Rystan Co., Inc. |
Chloresium Toothpaste Dental Ointment Solution |
| 080049 | The Lorvic Corp. |
Karidium Phospate Fluoride Topical Gel and Solution Additional Data |
| 080052 | Carter Products |
Sodium Fluoride Polymethylmethacrylate |
| 080053 | Carter Products | Dicalcium Phosphate |
| 080056 |
Dr. Lester D. Apperson (CTFA Liaison Rep.) |
Dentifrices |
| 080057 | Lorvic Corp. | Stannous Fluoride |
| 080058A | FDA |
Status of Topical Fluoride Preparations |
| 080060 | American Pharmaceutical Association | Fluoride Dentifrices |
| 080062 | NDK Company | NDK Dentifrice |
| 080083 | Barnangan AB |
Vademecum Chewing Gum |
| 080092 |
Dr. Lester D. Apperson (CTFA Liaison Rep.) |
Sodium Fluoride |
| 080097 | Proctor & Gamble Co. | Anticaries Agents |
| 080098 | Proctor & Gamble Co. | Crest Toothpaste |
| 080099 | Proctor & Gamble Co. | Gleem II Toothpaste |
| 08 0102 | Janar Co., Inc. | Iradicav |
| 080103 |
Dr. Lester D. Apperson (CTFA Liaison Rep.) |
Sodium Monofluoro-phosphate Dentifrices |
| 080109 | Warner lambert |
Sodium Fluoride Rinse Additional Data |
| 080115 | FDA | Workshop on Fluorides and Dental Caries Reduction |
| 080118 | Proctor & Gamble Co. | Stannous Fluoride Dentifrices |
| 080119 | Colgate-Palmolive |
Sodium Monofluoro-phosphate Dentifrices Additional Data |
| 080123 | Beecham Products |
McLeans Toothpaste Additional Data |
| 080126 | Beecham Products |
McLeans Toothpaste Additional Data |
| 080127 | Lever Brothers |
Aim Stannous Fluoride Toothpaste |
| 080128 | Colgate-Palmolive | Fluoride Dentifrice |
| 080131 | Church & Dwight | Arm & Hammer Baking Soda, Arm & Hammer Toothpaste |
| 080133 | Beecham Products |
McLeans Toothpaste Additional Data |
|
080134 080134A |
Colgate-Palmolive |
Sodium Fluoride Sodium Bicarbonate Dentifrice Additional Data |
|
080135 080136 |
Warner lambert | Acidulated Fluoride-Phosphate Mouth Rinse |
| 080137 | Beecham Products |
McLeans Toothpaste Additional Data |
| 080138 | Colgate-Palmolive | Sodium Monofluoro-phosphate |
| 080139 | Proctor & Gamble Co. | Crest Toothpaste |
| 080141 | Warner lambert | DiCal Chewing Gum |
| 080141A | Warner lambert | DiCal Chewing Gum |
| 080142 | Lever Brothers | Fluoride Dentifrices Testing |
| 080143 | Warner Lambert | DiCal Chewing Gum |
| 080143B | Warner Lambert | DiCal Chewing Gum |
| 080146 | Perident Co., Inc. | Perident Salt Toothpaste |
| 080148 | Janar Co., Inc. |
Iradicav Additional Data |
|
080149 080150 |
Warner Lambert |
Stannous Fluoride Mouthrine Tablet |
| 080152 |
CTFA - PA Dentifrice Task Force |
Agents Used to Formulate Dentifrices |
| 080153 | Lever Brothers |
Silica Based Dentifrice Containing NaMFP Additional Data |
| 080154 | Colgate-Palmolive |
MFP Dentifrices Additional Data |
| 080155 | CTFA - PA | Fluoride Dentifrices |
| 080155A | Dentifrice Task Force | |
| 080159 | Beecham Products |
Fluoride Dentifrice Additional Data |
| 080160 | Warner Lambert | DiCal Chewing Gum |
| 080168 | Rystan Co., Inc. |
Chloresium Toothpaste Dental Ointment and Solution Additional Data |
| 080173 |
CTFA - PA Dentifrice Task Force |
Laboratory Profile on Fluoride Dentifrices |
| 080174 | Colgate-Palmolive | Colgate Dental Cream |
| 080176 | Beecham Products | Fluoride Dentifrices |
| 080177 | Lever Brothers | Laboratory Profile on Fluorides |
| 080178 | Proctor & Gamble Co. | Laboratory Profile on Fluorides |
| 080179 | Warner Lambert | DiCal Chewing Gum |
| 080182 | Lever Brothers |
Aim Stannous Fluoride Toothpaste Additional |
| 080185 | Colgate-Palmolive |
Silica/MFP Dentifrices |
| 080192 | Colgate-Palmolive |
Abrasive/MFP Combination |
| 080194 | Colgate-Palmolive |
Sodium Bicarbonate/ Sodium Fluoride |
| 080195 | Carter Products |
Fluoride in Polymethylmethacrylate-Based Dentifrice Additional Data |
| 080197 | Warner Lambert | Fluoride Mouthrinses |
| 080199 | Barnagen AB |
Vademecum Sugarless Gum Additional Data |
| 080200 | Lever Brothers |
Aim Stannous Fluoride Tooth paste Additional Data |
| 080201 | Colgate-Palmolive | Dentifrice Definitions |
| 080202 | Carter Products |
Pearl Drops Dentifrice |
| 080204 | Lever Brothers |
Aim Stannous Fluoride Toothpaste Additional Data |
| 080205 | Carter Products | Dentifrice Definitions |
| 080206 | Proctor & Gamble Co. | Dentifrice Definitions |
| 080207 | Beecham Products | Dentifrice Definitions |
| 080209 | Lever Brothers |
Stannous Fluoride Silica Gel |
| 080210 | Lever Brothers | Fluoride Dentifrices |
| 080215 | Colgate-Palmolive |
Fluoride Dentifrices Additional Data |
| 080217 | Lever Brothers |
MFP Silica Based Dentifrice Additional Data |
| 080232 | Lever Brothers |
Aim Stannous Fluoride Toothpaste Additional Data |
| 080233 | Lever Brothers | Fluoride Dentifrice Testing |
| 080235 | Colgate-Palmolive | Sodium Monofluoro-phosphate Dentifrices |
| 080237 | Proctor & Gamble/PA task force | Laboratory Profiles on Fluorides |
| 080238 | Lever Brothers | Laboratory Profiles on Fluorides |
| 080243 | Proctor & Gamble Co. | Laboratory Profiles on Fluorides |
| 080245 | The Proprietary Association | Laboratory Profiles on Fluorides |
| 080246 | Church & Dwight | Sodium Bicarbonate |
| 080248 | The Proprietary Association | Standards for Fluoride Dentifrices |
| 080249 | Proctor & Gamble Co. |
Crest Toothpaste Gleem Toothpaste |
| 080251 | Lever Brothers |
Proctor & Gamble Co. Submission 080249 |
| 080253 | The Proprietary Association | Reference Formulations |
| 080256 | Westwood Research | Testing Procedures for Fluoride Dentifrices |
| 080260 | Life Savers, Inc. & CSR, Limited | Calcium Sucrose Phospate |
Public Administrative File
OTC Anticaries Drug Products
(Docket No. 80N-0042)
General Dental Submissions
| VOLUME | SOURCE | REMARKS |
|---|---|---|
| 080058 | FDA |
NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) |
| 080059 | FDA | Cross Index to Data Submission. |
| 080061 | FDA | 35th and 36th Editions of “Accepted Dental Therapeutics”--Furnished at Panel’s Request. |
| 080064 | FDA |
OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
| 080065 | FDA |
OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General |
| 080066 | FDA |
OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
| 080067 | FDA |
OTC Drug Literature Program X. Dentifrices-Part III (L-O) L. Sodium N-Lauroyl M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
| 080106 | FDA |
Color Additive Regulations-1974 (Requested by Panel). |
| 080236 | FDA | Labels from All Submissions. |
Public Administrative File
OTC Anticaries Drug Products
(Docket No. 80N-0042)
Alphabetical Listing of
References Cited in Report
| VOLUME | CONTENTS |
|---|---|
| 080266 | A-F |
| 080267 | G-H |
| 080268 | I-M |
| 080269 | N-Z |
| 080270 | Miscellaneous Uncited References |
Public Administrative File
OTC Anticaries Drug Products
(Docket No. 80N-0042)
Panel Administrator’s File
| VOLUME | CONTENTS |
|---|---|
| 08APA1 |
Panel Administraotr’s File, Volume I - General 1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Regulatory Analysis Assessment 1.7 Statement of Exemption and Environmental Assessment Reprot |
| 08APA2 |
Panel Administrator’s File, Volume II - Minutes of Panel Meetings |
| 08APA3 |
Panel Administrator’s File, Volume III - Correspondence File, (1972-1974). |
| 08APA4 |
Panel administrator’s File, Volume IV - Correspondence File, (1975-1976). |
| 08APA5 |
Panel Administrator’s File, Volume V - Correspondence File, (1977-1979).. |
Public Administrative File
OTC Drug Products For the Relief of Oral Discomfort
(Docket No. 80N-0228)
| VOLUME | SUBMITTED BY | TRADE NAME/SUBJECT |
|---|---|---|
| 080001 | Abbott Laboratories |
Butyn Metaphen Dental Ointment |
| 080002 | Eneglotaria Medicine Co., Inc. Of Puerto Rico |
Gotas Dentil, Erpen |
| 080003 | C.S. Dent & Co. |
Dent’s Toothache Drops Treatment, Dent’s Toothache Gum, Dent’s Lotion-Jel, Dent’s Dental Poultice |
| 080010 | The Lorvic Corp. | Desensitizer |
| 080013 | Denver Chemical Manufacturing Co. | Pain-A-Lay |
| 080014 | Zelite Corp. | Dent-Zelite |
| 080017 | Vick Chemical Co. | Benzodent |
| 080028 | K.I.K. Co. | Cheramist # 30 |
| 080032 | John Arthur Geyer Co. | Kank-A |
| 080033 | Block Drug Co. Inc. | Sensodyne |
| 080034 | Denver Chemical Manufacturing Co. |
Dr. Hand’s Teething Lotion, Dr. Hand’s Teething Gel |
|
080035 080036 080037 |
Norwich Pharmacal Co. |
Chloraseptic Mouthwash and Gargle, Chloraseptic Lozenges, Chloraseptic Aerosol Spray |
| 080042 | Pfizer, Inc. | Thermodent |
| 080048 | Commerce Drug Co., Inc. |
Ora-Jel, Baby Ora-Jel, Ora-Jel D |
| 080052 | Carter-Wallace, Inc. |
Sodium Fluoride General Safety and Efficacy Data |
| 080054 | Sterling Drug, Inc. | Campho-Phenique |
| 080055 | Whitehall Laboratories, Inc. | Anbesol |
| 080057 |
Dr. Robert Stearns (Lorvic Corp.) |
Article on Stannous Fluoride |
| 080060 | AphA |
Letter of 5-21-73 Regarding Fluoride Dentifrices |
| 080063 | A-trol Laboratories | I.D. Denture Medication |
| 080064 | FDA |
FDA Literature Search Dental Products Abstracts |
| 080070 | Zelite Corp. |
Dent-Zelite Additional Data |
|
080071 080072 |
McKessan Laboratories | Ora-Fix-M |
| 080073 | Zelite Corp. |
Dent-Zelite Additional Data |
| 080081 | Block Drug Co., Inc. | Jiffy Toothache Drops |
| 080084 |
Eaton Labs. Div. Of Morton-Norwich Products, Inc. |
Chloraseptic Mouthwash and Gargle Additional Data |
| 080085 | International Pharmaceutical Corp. | DeSense Dental Gel |
| 080086 | American Dental Association | Data on Toothache Preparations |
| 080089 | Sterling Drug, Inc. |
Campho-Phenique Additional Data |
| 080093 | Sterling Drug, Inc. |
Campho-Phenique Additional Data on Rationale for Inclusion of Camphor |
| 080095 | International Pharmaceutical Corp. | Protect Dental Gel |
| 080101 | Whitehall Laboratories, Inc. |
Anbesol Additional Data |
| 080107 | International Pharmaceutical Corp. |
Protect Dental Gel Additional Data |
| 080112 | Warner Lambert Co. |
Thymol Additional Data |
| 080114 | Commerce Drug Co. |
Ora-Jel Additional Data |
| 080117 | International Pharmaceutical Corp. |
Protect Dental Gel Additional Data and Protocol for a Clinical Study |
| 080118 | Colgate-Palmolive Co. |
Additional Data (Stability) |
| 080119 | Colgate-Palmolive Co. |
Additional Data on Sodium Monoflurophosphate |
| 080125 | Whitehall Laboratories, Inc. |
Anbesol Additional Formulation Data |
| 080128 | Colgate-Palmolive Co. | Suggested Guidelines for Fluoride Dentifrices |
| 080152 |
CTFA-PA Dentifrice Task Force |
Agents Used to Formulate Dentifrices |
| 080173 |
CTFA-PA Joint Task Force |
Summary of Laboratory Profile on Fluoride Dentifrices |
| 080174 | Colgate-Palmolive Co. |
Sodium Monofluorophosphate Summary of Laboratory Profile |
| 080176 | Beecham Products, Inc. |
Data on Fluoride Dentifrice Expiration Dating |
| 080177 | Lever Brothers | Data on Fluoride Laboratory Testing Profile and Expiration Dating |
| 080178 | Procter and Gamble Co. | Data on Laboratory Testing Profile for Fluoride |
| 080180 | The Rilox Coo. | Creole Toothpaste Wax |
| 080191 | Block Drug Co., Inc. | Poloris Dental Poultice |
| 080193 | Whitehall Laboratories, Inc. | Comments on Proposed Ethanol Limits |
| 080198 | Block Drug Co., Inc. |
Sensodyne Additional Data |
| 080210 | Lever Brothers | Formulation Changes for Fluoride Dentifrices |
|
080211 080212 080213 |
Abbott Laboratories |
Butyn Dental Ointment Additional Studies |
| 080214 | Block Drug Co., Inc. |
Poloris Dental Poulice Additional Data |
| 080216 |
Glenbrook Labs., Div. Of Sterling Drug, Inc. |
Campho-Phenique Additional Data |
|
080221 080222 |
Protect Dental Gel Additional Data |
|
| 080223 | Proprietary Association | Protocol Guidelines for Densensitizing Dentifrices |
| 080224 | Block Drug Co., Inc. |
Sensodyne Additional Efficacy Data |
| 080225 | Marion Laboratories, Inc. |
Protect Dental Gel Additional Safety Data on Pluronic Polyolis in General, Pluronic F-127 and Efficacy Data |
| 080226 | Block Drug Co., Inc. | Comparative Active and Placebo Formulation Data |
| 080227 | BASF Wyandotte Corp. | Toxicity Data on Pluronic Polyols |
| 080229 | Vick Chemical Co. | Potassium Nitrate Toothpaste |
| 080230 | Vick Chemical Co. |
Potassium Nitrate Toothpaste Testing Methodology |
| 080231 | Vick Chemical Co. |
Potassium Nitrate Toothpaste Testing Methodology Proposed Protocol |
| 080237 | Proctor and gamble Co./PA Task Force | Fluoride Profiles |
| 080238 | Lever Brothers |
Fluoride Laboratory Profile Tests |
| 080239 | Proprietary Association | Protocol for Testing Tooth Desensitizers |
| 080240 | Proprietary Association | Presentation on Tooth Desensitizer Testing |
| 080241 | Vick Chemical Co. | Status of Potassium Nitrate as a Tooth Desensitizer |
| 080243 | H.V. Shuster & Co. | Stannous Fluoride/IMP Laboratory Profile |
| 080245 | PA Task Force | Fluorides Laboratory Profile |
| 080248 | PA Task Force | Standards for Fluoride Dentifrices |
| 080250 | Sanlor Laboratories | Endoflas, F.S. |
| 080250A | Sanlor Laboratories |
Endoflas, F.S. Appendix |
| 080252 | Marion Laboratories, Inc. |
Protect Dental Gel Additional Data |
| 080253 |
PA Subgroup on Fluoride Dentifrices |
Fluoride Dentifrices Reference Formulations |
| 080254 | Sanlor Laboratories |
Endoflas, F.S. Additional Data |
| 080255 | Commerce Drug Co., Inc. |
Baby Ora-Jel Additional Data |
| 080256 | Westwood Research Lab | Testing Procedures on Fluoride Dentifrices |
| 080257 | Block Drug Co., Inc. |
Sensodyne New Clinical Study |
| 080258 | Whitehall Laboratories, Inc. |
Anbesol Additional Data |
| 080259 | Vick Chemical Co. |
Testing Method for Tooth Desensitizers Additional Data |
Public Administrative File
OTC Drug Products for the Relief of Oral Discomfort
(Docket No. 80N-0228)
Genreal Dental Submissions
| VOLUME | SOURCE | REMARKS |
|---|---|---|
| 080058 | FDA |
NAS/NRC (DESI) Reports. (Panel on Drugs Used in Dentistry) |
| 080059 | FDA | Cross Index to Data Submission. |
| 080061 | FDA | 35th and 36th Editions of “Accepted Dental Therapeutics”--Furnished at Panel’s Request. |
| 080064 | FDA |
OTC Drug Literature Program XI. Dental Products A. Benzocaine B. Camphor C. Choline Salicylate D. Erythrosin E. Eugenol F. Hydrogen Peroxide G. Karaya Gum, Powdered H. Potassium Iodide J. Silver Nitrate K. Tannic Acid |
| 080065 | FDA |
OTC Drug Literature Program X. Dentifrices-Part I (A-F) A. Reviews B. Ammoniated Dentifrices’ C. Ammonium Phosphate, Dibasic D. Chloroform E. Dicalcium Phosphate F. Fluoride, General |
| 080066 | FDA |
OTC Drug Literature Program X. Dentifrices-Part II (G-K) G. Formaldehyde H. Hydrogen Fluoride J. Sodium Borate K. Sodium Fluoride |
| 080067 | FDA |
OTC Drug Literature Program X. Dentifrices-Part III (L-O) L. Sodium Monofluoro- phosphate M. Sodium N-Lauroyl Sarcosinate N. Stannous Fluoride O. Strontium Chloride |
| 080106 | FDA |
Color Additive Regulations-1974 (Requested by Panel). |
| 080236 | FDA |
Labels from All Submissions. |
Public Administrative File
OTC Drug Products for the relief of Oral Discomfort
(Docket No. 80N-0228)
Alphabetical Listing of
References Cited in Report
| VOLUME | CONTENTS |
|---|---|
| 080271 | A-F |
| 080272 | G-P |
| 080273 | Q-Z |
| 080274 | Miscellaneous Uncited Reference |
Public Administrative File
OTC Drug Products for the Relief of Oral Discomfort
Docket No. 80N-0228)
Panel Administrator’s File
| VOLUME | CONTENTS |
|---|---|
| 08BPA1 |
Panel Administrator’s File, Volume I - General 1.1 Calls for Data 1.2 List of Panel Memebrs and Liaisons 1.3 Curriculum Vitae for Panel Members and Liaisons 1.4 General and Specific Charges to Panel 1.5 Index of Panel Submissions 1.6 Minutes of Panel Meetings |
| 08BPA2 |
Panel Administrator’s File Volume II - Correspondence File, (1972-1982). |
