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U.S. Department of Health and Human Services

Regulatory Information

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OTC Panel Submissions (Indices Only): 12 - Hemorrhoidal (Anorectal)

Hemorrhoidal (Anorectal)

VOLUME SUBMITTED BY SUBJECT
120001 Upjohn Tanicaine Rectal Ointment and Suppositories
120002 Upjohn Epinephricaine
120003 Astra Xylocaine 2.5% & 5% Ointment
120004 Warner-Chilcott Anusol Suppositories and Ointment
120005 Resinol Chemical Company Resinol Greaseless Cream
120006 Wyeth Labs Wyanoids Suppositories Wyanoid Ointment Protegel
120007 Whitehall Preparation H Ointment and Suppositories Volume I
120008 Whitehall Preparation H Ointment and Suppositories Volume II
120009 Whitehall Preparation H Ointment and Suppositories Volume III
120010 Ciba-Geigy Nupercainal Ointment and Suppositories Volume I
120011 Ciba-Geigy Nupercainal Ointment and Suppositories Volume II
120012 Chesebrough-Pond’s Vaseline
120013

Sterling Drug

Winthrop  Labs. Div

Pontocaine Cream and Ointment Volume I
120014

Sterling Drug

Winthrop  Labs. Div.

PNS Suppositories Volume II
120015 Abbott Tronothane
120016 Combe Lanacane Creme
120017

Quist Chemical

Phenex

Quist Ointment

Phenex Rectal Suppositories

120018 Combe Lanacane Creme
120019 Fuller Tucks
120020 Pfizer Benzyl Alcohol
120021 Whitehall Live Yeast Cell Derivative
120022 Ciba-Geigy Nupercainal Ointment and Suppositories
120023 Ciba-Geigy Nupercainal Ointment and Suppositories
120024

Sterling Drug

 Winthrop  Labs. Div.

PNS Suppositories
120025 Merrell-National Diothane Ointment
120026 Sterling Drug Tyloxapol
120027 Ciba-Geigy Nupercainal Ointment and Suppositories
120028 Sterling Drug PNS Suppositories
120029 Dow Chemical Dyclone Creme
120030

Dr. Kade

Pharmazeutische

Posterisan
120031 Bristol-Myers Pazo Ointment and Suppositories
120032 Whitehall Skin Respiratory Factor
120033 Fuller Tucks
120034 Humphreys Hamamelis Water
120035 Bristol-Myers Medicated Anal Wipe Foam
120036

Dr. Kade

Pharmazeutische

Posterisan
120037 Bristol-Myers Aerosol Medicated Anal Wipe Foam
Combe Resorcinol
120039 Reed & Carnrick Non-Steroid Proctofoam
120040 Ciba-Geigy Nupercainal Ointment and Suppositories
120041 Ciba-Geigy Nupercainal Ointment and Suppositories
120042 Ciba-Geigy Nupercainal Ointment and Suppositories
120043 Phenex Phenex
120044 Combe Resorcinol
120045 Bristol-Myers Combination Policy Remarks
120046 Philips-Roxane Gentz Wipes
120047 Combe Lanacane Creme
120048 Combe Resorcinol
120049 Combe Resorcinol
120050 Reed & Carnrick Non-Steroid Proctofoam
120051 Various Sources Unpublished References
120052 Chesebrough-Pond’s Vaseline
120053

Bellwood 

Pharmaceutical

Hemozone
120054 University of  Nebraska  Medical  Center Camphor
120055 Astra Xylocaine Ointment
120056 Proprietary Association Criteria For Placing Category III Ingredients in Category I
120057 Schwarting

Lappa/Leptandra

Collinsonia

120058 Proprietary Association Combination Policy Statement
120059 Dow Chemical Dyclone Creme 1%
120060 Whitehall Skin Respiratory Factor
120061 Dr. Trunkey Donor Site Wound Study
120062 American Home Products Skin Respiratory Factor
120063 Chesebrough-Pond’s Vaseline
120064 Ciba-Geigy Nupercainal Ointment and Suppositories
120065 Reed & Carnrick Non-Steroid Proctofoam
120066 Warner-Chilcott Anusol Suppositories
120067 Malmstrom Chemicals Lanolin and its Derivatives
120068 Merrell-National Diothane Ointment
120069 American Home Products Skin Respiratory Factor
120070 Ciba-Geigy Nupercainal Ointment and Suppositories
120071 Ciba- Geigy Nupercainal Ointment Protocol
120072 Arnar-Stone Benzocaine
120073 Merrell-National Diothane Ointment/NDA 1-941
120074 Proprietary Association Combination & Testing Policies Comments
120075 Merrell-National Diothane Ointment
120076 Ciba-Geigy Nupercainal Ointment and Suppositories
120077 Ciba-Geigy Nupercainal Ointment and Suppositories
120078 Ciba-Geigy Nupercainal Ointment
120079 Schuylkill  Chemical Allantoin & Alcloxa
120080 Proprietary Association Comments on Panel’s Draft Report Released December 1977
120081 Ciba-Geigy Nupercainal Suppositories
120082 Whitehall Skin Respiratory Factor
120083 Whitehall Miscellaneous Hemorrhoidal Product Labeling
120084 Abbott Tronothane Cream & Jelly
120085 Merrell-National Diothane Ointment Volume I
120086 Merrell-National Diothane Ointment Volume II
120087 Proprietary Association

Combination & Testing Policies

(Same as Volume 120074)

120088 Astro-Solar Tengum
120089 Boston  University Nupercainal Ointment and Suppositories
120090 Ciba-Geigy Transcript of 5/3/75 Meeting
120091 Chesebrough-Pond’s Corrections of Summary Minutes of 27th Meeting of Hemorrhoidal Panel
120092 Whitehall Skin Respiratory Factor Presentation
120093 Whitehall

Skin Respiratory

Factor Presentation (References)

Alphabetical Listing of

References Not Cited in Report

VOLUME CONTENTS
120103 A-B
120104 C-D
120105 E-G
120106 H-K
120107 L-O
120108 P-Z

ADMINISTRATIVE FILE

 

OTC Anorectal Drug Products

Docket No.  80N-0050

 

PUBLIC ADMINISTRATOR’S FILE

VOLUME CONTENTS
12APA1

Panel Administrator’s File, Volume I - General

1.1   Call for Data

1.2   List of Panel Memebers and Liaisons

1.3   Curriculum Vitae of Panel Members and Liaisons

1.4   General and Specific Charges to Panel

1.5   Index to Panel Submissions

1.6   Regulatory Analysis Assessment

1.7   Statement of Exemption and Environmental         Assessment Report

12APA2 Panel Administrator’s File, Volume II - Minutes of Panel Meetings.
12APA3 Panel Administrator’s File, Volume III - Correspondence File (1972-1980)

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