Over the Counter (OTC) Panel Submissions (Indices Only): 06- Topical Analgesic (Section 3)

Panel Administrator’s File

VOLUME	CONTENTS
06BPA6	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    Minutes of Panel Meetings
	1.7    Correspondence
	1.8    Cited References
	1.9    Uncited References

External Analgesic Drug Products 

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record;

OTC Drug Products for the Prevention of Poison Ivy,& Oak, and Sumac

Part II
Docket No.  78N-0301

Index to OTC Volumes

VOLUME	SUBMITTED BY	PRODUCT
160074	Marion Health and Safety, Inc.	Poison Ivy Wash
160103	Unimed, Inc.	Residerm (Poison Ivy Lotion)
160132	Marion Health and Safety, Inc.	Zircreme, Ferric Chloride, Sting-Kill
160152	Poison Ivy Wash

ADMINISTRATIVE FILE

External Analgesic Drug Products for OTC Human Use; Establishment of a 

Monograph and Reopening of Administrative Record;

Published in the FEDERAL REGISTER on 

September 7, 1982 (47 FR 39412)

Part II

Statement on OTC Drug Products for the

Prevention of Poison Ivy, Oak, and Sumac

Docket No. 78N-0301

Panel Administrator’s File

VOLUME	CONTENTS
06BPA7	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     Minutes of Panel Meetings
	1.7     Correspondence
	1.8.    References

External Analgesic Drug Products 
For OTC Human Use; Establishment of a 
Monograph and Reopening of Administrative Record: 
OTC Drug Products for the Treatment of Fever Blisters

Part III
Docket No.  78N-0301

Index to OTC Volumes

VOLUME NO.	SUBMITTED BY	PRODUCT
160008	Commerce Drug Co., Inc.	Bio-Stik
160012	Commerce Drug Co., Inc.	Tanac
160013	Commerce Drug Co., Inc.	Tanac Stik
160048	Campbell Laboratories, Inc.	Herpecin-L
160096	Blistex, Inc.	Blistex Ointment
160136	Sterling Drug Inc.	Campo-Phenique
160177	International Pharmaceutical Corp.	Gly-Oxide Liquid
160197	Oral Prophylactic Assoc., Inc.	Mouth Komfort
160213	Blistex, Inc.	Blistik Lip Balm
160218	Glenbrook Laboratories	Campho-Phenique
160231	Sterling Drug, Inc.	Campho-Phenique

ADMINISTRATIVE FILE

External Analgesic Drug Products

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

Published in the FEDERAL REGISTER on

September 7, 1982 (47 FR 39412)

Part III

Statement on OTC Drug Products

For the Treatment of Fever Blisters

Docket No. 78N-0301

Panel Administrator’s File

VOLUME	CONTENTS
06BPA8	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     Minutes of Panel Meetings
	1.7     Correspondence
	1.8     References

External Analgesic Drug Products

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

OTC Male Genital Desensitizing Drug Products

Part IV

Docket No.  78N-0301

Index to OTC Volumes

VOLUME	SUBMITTED BY	PRODUCT
160001	Frederick Damrau, M.D.	Culminal
160014	Commerce Drug Co., Inc.	Detane
160171	Ciba-Geigy Corp.	Nupercainal Ointment
160260	Keller and Heckman for Pound International Corp.	Stud-100
160266	Keller and Heckman for Pound International Corp.	Stud-100
160281	Del laboratories	Detane
160290	Commerce Drug Co., Inc.	Detane
160388	Del Laboratories	Detane
06BPA9-A		Cited References
06BPA9-B		Uncited References

ADMINISTRATIVE FILE

External Analgesic Drug Products

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

Published in the FEDERAL REGISTER on

September 7, 1982 (47 FR 39412)

Part IV

Statement on OTC Male Genital Desensitizing Drug Products

Docket No.   78N-0301

Panel Administrator’s File

VOLUME	CONTENTS
06BPA9	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     Minutes of Panel Meetings
	1.7     Correspondence

External Analgesic Drug Products

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

OTC Astringent Drug Products

Part V

Docket No.  78N-0301

Index to OTC Volumes

VOLUME	SUBMITTED BY	MARKETED PRODUCTS /SUBJECT
160022	Marion Laboratories Inc.	Bluboro Powder
160038	Dome Laboratories	Acid Mantle, Creme, Lotion
160039	Dome Laboratories	Domeboro Tablets, Powder
160069	Cooper Laboratories, Inc.	Acnaveen Bar, Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur-Veen Wet Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo
160070	Cooper Laboratories, Inc.	Acnaveen Bar, Cream, Aveeno Bar, Bath, Oilated Bath, Avenol Bath Additive, Bur Veen Wet Dressing Powder, Emulave Bar, Nixoderm Ointment, Packers Pine Tar Shampoo, Soap, Sebaveen Shampoo
160093	R. L. Gaddy Co.	Ez-It Medicted Foot Powder
160140	Marion Laboratories, Inc.	Bluboro Powder
160219	Marion Laboratories, Inc.	Bluboro Powder
160230	Marion Laboratories, Inc.	Bluboro Powder
160233	Cox Drugs	Formula “U”
160354	Humpheys Pharmacal, Inc.	Witch Hazel
160396	Stiefel Research Institute, Inc.	AluWets
160409	Perito, Duerk, Carlson & Pinco for Requa Manufacturing Co., Inc.	Aluminum Sulfate Styptic Pencil
160413	The Woltra Company, Inc.	Aluminum Sulfate Styptic Pencil
160428	The E. E. Dickinson Co.	Witch Hazel
160429	Beecham Products	OTC Astringent Vaginal Douche Drug Products
160433	American Distilling and Manufacturing Co., inc.	Witch Hazel Study
160435	Requa Manufacturing Co., Inc.	Aluminum Sulfate
06BPA10-A		Cited References
06BPA10-B		Uncited References

ADMINISTRATIVE FILE

External Analgesic Drug Products

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

Published in the FEDERAL REGISTER on

>

September 7, 1982 (47 FR 39412)

Part V 

Statement on OTC Astringent Drug Products - Docket No. 78N-0301

Panel Administrator's File

VOLUME	CONTENTS
06BPA10	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     Minutes of Panel Meetings
	1.7     Correspondence

External Analgesic Drug Products 
For OTC Human Use; Establishment of a 
Monograph and Reopening of Administrative Record
OTC Insect Bite Neutralizer Drug Products

Part VI 
Docket No. 78N-0301

Index to OTC Volumes

VOLUME	SUBMITTED BY	PRODUCT
160074	Marion Health and Safety, Inc.	Sting Kill Swabs
160119	Tender Corp.	After Bite
160132	Marion Health and Safety, Inc.	Sting Kill Swabs
160159	Marion Health and Safety, Inc.	Sting Kill Swabs
160434	Tender Corp.	After Bite

AMINISTRATIVE FLE

External Analgesic Drug Products 

For OTC Human Use; Establishment of a

Monograph and Reopening of Administrative Record

Published in the FEDERAL REGISTER on

September 7, 1982 (47FR 39412)

Part VI

Statement on OTC Insect Bite Neutralizer Drug Products

Docket No.  78N-0301

Panel Administrator's File

VOLUME	CONTENTS
06BPA11	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     Minutes of Panel Submissions
	1.7     Correspondence
	1.8     References

ADMINISTRATIVE FILE 

 

Skin Protectant Drug Products for OTC Human Use

Establishment of a Monograph and Reopening of Administrative Record

Docket No.  78N-0021

 

Volume

06DPA2

 

In the FEDERAL REGISTER of September 7, 1982 (47 FR 39436), the administrative record for the OTC skin protectant drug products rulemaking was opened to include 5 statements by the Advisory Review Panel on OTC Miscellaneous External Drug Products.  To avoid duplication, the Public Administrative File for these 5 statements appears as parts of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412).

The name of each statement included in the skin protectant rulemaking and its corresponding volume number in the external analgesic administrative file appears below.

STATEMENT	VOLUME NO.
OTC Drug Products for the Treatment of Diaper Rash	06BPA6
OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac	06BPA7
OTC Drug Products for the Treatment of Fever Blisters	06BPA8
OTC Astringent Drug Products	06BPA10
OTC Insect Bite Neutralizer Drug Products	06BPA11

TFM VOLUME 060TFM 

 

Has been established for Topical Otic Drug Products

 

 

TFM VOLUME 06BTFM            

 

Has been established for EXTERNAL ANALGESIC DRUG PRODUCTS PART OF TOPICAL ANALGESIC

 

 

TFM VOLUME 06DTFM

 

Has been established for Skin Protectant Drug Products