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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