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OTC Panel Submissions (Indices Only): 11 - Contraceptives and Other Vaginal Drug Products

OTC CONTRACEPTIVE SUBMISSIONS

(149A/0080A)

October 26, 1979

VOLUME FIRM PRODUCT OR DATA PRODUCT LABELED INGREDIANTS
110001

Center for Science in the Public Interest

Washington   D.C.   20036

FDA

FDA

Talc

Literature Search

DESI publications

 
110004

Holland Rantos Co., Inc.

Trenton ,  NJ  08854 

Koromex Contraceptive Jelly,

Koromex Contraceptive Cream,

Korpmex Contraceptive Jelly

Boric acid, phenylmercuric acetate

“       ”         “      ”

Boric acid, polyoxyethylene nonyl phenol, phenyl-mercuric acetate

110005

Ortho Pharmaceutical Corp.

 Raritan ,  NJ  08869 

Ortho Gynol Contraceptive Jelly p-Diisobutylphenoxypoly-ethoxyethanol
110006

Ortho Pharmaceutical Corp.

Raritan ,  NJ  08869 

Preceptin Contraceptive Gel

p-Diisobutylphenoxypoly-

ethoxyethanol

110007

Ortho Pharmaceutical Corp.

Raritan ,  NJ  08869 

Ortho-Creme

Contraceptive Cream

Nonoxynol-9
110012/14

Norwich Pharmacal Co.

NY 13815

Norwich Pharmacal Co.

NY 13815

Lorophyn jelly

Lorophyn Contraceptive Suppositories

PMA, octoxynol, methylparaben, sodium borate

PMA, methylbenzethonium chloride, methylparaben

110016

Juluis Schmid, Inc.

New York ,  NY  10019 

Immolin Contraceptive Vaginal Cream - Jel

methoxypolyoxyethylene glycol

550 Laurate

Nonyl phenoxypolyethoxy ethanol.

110017

Juluis Schmid, Inc.

New York ,  NY  10019 

Finesse Contraceptive Creme - gel

methoxypolyoxyethylene glycol

550 Laurate,

nonoxynol-9

110018

Juluis Schmid, Inc.

New York ,  NY  10019 

Finesse Contraceptive Creme - Gel

Methoxypolyethylene glycol

550 laurate, nonoxynol-9

110020

Juluis Schmid, Inc.

New York ,  NY  10019 

Ramses Contraceptive

Vaginal Jelly

Dodecaethylene glycol mono-laurate, boric acid, alcohol
110021

Holland Rantoes Co., Inc.

Piscataway ,  NJ  08854 

Improved Koromex

Contraceptive Jelly

Laureth 10S
110026

Ortho Research Foundation

Raritan ,  NJ  08869 

Selective Bibliography on Vaginal Contraception and Therapeutics  
110028A

Schmid Laboratories

Little Falls, NJ 07424

Supp’l data; Vagesic, Ramses jelly,

Immolin cream - jel

 
110030

Schmid Laboratories,

Little Falls, NJ 07424

Supp’l data; Immolin and Finesse Contraceptives

combo of methoxypolyoxyethylene

glycol 550 Laurate and Nonoxynol - 9

110033

Ortho Pharmaceutical Corp.

Raritan,  NJ  08869 

“              ”               “

Rabbit Model preprint

3 references lists re: spermphsiology and animal models for vaginal contraceptives.

 
110036

Emko Company

St. Louis ,  MO  63147 

Emko contraceptive foam

Because contraceptive foam

nonyl phenoxy polyoxyethylene ethanol.

Benzethorium chloride

“               ”                 “

110040/41

Ortho Pharmaceutical Corp.

Raritan ,  NJ  08869 

Vaginal Contraceptive foaming tablet-safety and effectiveness Menfegol
110045

Proprietary Assn.

Wash. , DC.   20006

OTC Labeling Indications  
110049 Juliu Schmid, Inc. Ramses Dodecaethylene glycol monolaurate
110050

Nova Corp of  America 

Cos   Cob ,  CT  06807

Flavo-Cept. Contraceptive jelly

polyethylene glycol

600 monolaurate (PEG-12 Laurate, Dodecaethylene glycol monolaurate

110052 FDA Mercury Correspondence  
110053

Ortho Research Foundation

Raritan ,  NJ  08869 

Selective Bibliography: 1975

Supplement to Volume 110026

 
110055

The Proprietary Assn.

Washington ,  DC  20006 

Comments on the November 1978

“Information Copy” - Panels Tentative Findings

 
110056

Whitehall  Laboratories

New York ,  NY  10017 

Semicid:   labeling presentation

December 7, 1978

Nonoxynol-9
110058 FDA

Cited References

(A-B)

 
110059 FDA

Cited References

(C-F)

 
110060 FDA

Cited References

(G-K)

 
110061 FDA

Cited References

(L-O)

 
110062 FDA

Cited References

(P-S)

 
110063 FDA

Cited References

(T-Z)

 
110064 FDA Uncited References  

ADMINISTRATIVE FILE

OTC Vaginal Contraceptive Drug Products

Docket No. 80N-0280

Panel Administrator’s File

VOLUME CONTENTS
11APA1

Panel Administrator’s File, Volume I - General

1.1    Call for Data

1.2    List of Panel Members and Liaisons

1.3    Curriculum Vitae of Panel Members and           Liaisons

1.4    General Charge to Panel

1.5    Index to Panel Submissions

1.6    Interim Recommendation on Encare Oval

1.7    Regulatory Analysis Assessment

1.8    Statement of Exemption and Environmental                   Assessment Report

1.9   Requests for Confidentiality

11APA2 Panel Administrator’s File, Volume II - Minutes of Panel Meetings
11APA3 Panel Administrator’s File, Volume III - Correspondence File (1973-1974)
11APA4 Panel Administrator’s File, Volume IV - Correspondence File (1975-1977)
11APA5 Panel Administrator’s File, Volume V - Correspondence File (1978)
11APA6 Panel Administrator’s File, Volume VI - Correspondence File (1978-1979)

VAGINAL DRUG PRODUCTS FOR

OVER-THE-COUNTER HUMAN USE

ADMINISTRATIVE RECORD

(DOCKET NO. 82N-0291)

INDEX TO PANEL SUBMISSIONS

VOLUME SUBMITTED BY SUBJECT
110001

Center for Science in the Public Interest

FDA

FDA

Talc

Literature Search

DESI Publications

110002 Reed & Carnrick Pharmaceuticals

Tricotine Powder

Tricotine Liquid

110003 McKesson Laboratories V.A. Douche Powder
110008 Chattem Drug & Chemical Company

Mata-Cine Concentrated Douche Powder

Pamprin Concentrated Douche Powder

110009 Rystan Company Prophyllin Powder
110010 Bristol-Myers Company Feminique Douche Liquid Concentrate
110011 Block Drug Company Femicare Powder
110015 Boyle and Company Triva Douche Powder
110019 Juluis Schmid, Inc. Vagesic Douche Liquid Concentrate
110022

Meri Jo. Inc.

G.M. Case Laboratories

Phenex Laboratories, Inc.

Fine’s Hygienic Powder

PAF Douche Powder

Complete Feminine Hygiene Antiseptic Deodorant Douche

Phenex Feminine

Hygiene Antiseptic

Phenex Vaginal Therapeutic Suppositories

Phenex Hygienic Suppositories

110023 Purdue Frederick Company Betadine Douche
110024 Norcliff Laboratories, Inc. Zonite, Zonitors
110025 Beecham, Inc. Massengill Liquid Douche
110027 Wyeth Laboratories, Inc. Propion Gel
110028B

Chattem Drug & Chemical Company

Louis Keit h, M.D.

Meta-Cine and Pamprin Douche Powders Vaginal Odors Preprint and References
110029

Beecham, Inc.

Purdue Frederick Company

Rystan Company

Wyeth Laboratories, Inc.

Young’s DrugProducts

Intravaginal Administration of   Boric Acid

Betadine Douche

Prophyllin Douche

Propion Gel

Polysorbate 20 as a Douche

110031 R. Schattner Company

Gynaseptic Vaginal Solution

Gynaseptic Vaginal Ointment

110032 Beecham, Inc. Boric Acid
110033 Ortho Pharmaceutical Corporation

Rabbit Model Preprint

Vaginal ph References

Guide to the Physiological Suitability of Atlas Surfactants

Cleansing Properties of Pluronic

 F-68

Surfactants as Vaginal Douches

Three Reference Lists

Re: Sperm Physiology and Animal Models for Vaginal Contraceptives

110034 International Playtex, Inc. Polysorbate 20 Safety Data
110035 Vick Divisions Research Douche Pipe Design and Minimum Volume for Cleansing
110037 Cosmetic, Toiletry, and Fragrance Association Talc
110038 Foster D. Snell Pressure Effects of Douching
110039 Reed & Carnrick Pharmaceuticals Douche Powders
110042/43 Aloe Vera of  America Vagistat Vaginal Douche
110044 U.S. Borax Research Corporation Boric Acid/Sodium Borate
110045 Proprietary Association OTC Labeling Indications
110046/48 GAF Corporation Povidone-Iodine
110051 Purdue Frederick Company Betadine Douche
110054 GAF Corporation Povidone-Iodine
110055 Proprietary Association Comments on Panel’s November 1978 Tentative Findings - “Information Copy”
110057 GAF Corporation Povidone-Iodine
110065  

Cited References

(A - D)

110066  

Cited References

(E - J)

110067  

Cited References

(K - P)

110068  

Cited References

(Q - T)

110069  

Cited References

(U - Z)

110070   Uncited References
llBPAI  

Panel Administrator’s

File (1.1 - 1.5)

llBPAII(See llAPA2)   Panel Administrator’s File (Minutes of Panel Meetings)
llBPAIII   Panel Administrator’s File (Correspondence 1973 - 1975)
llBPAIV   Panel Administrator’s File (Correspondence 1976 - 1977)
llBPAV   Panel Administrator’s File (Correspondence 1978 - 1979)

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