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