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OTC - Panel Submissions (Indices Only): 08 - Dentifrices and Dental Care Agents

Public Administrative File

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

 Marion laboratories, Inc.

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).

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