OTC Panel Submission (Indices Only): - 16 - Miscellaneous (con't)

Public Administrative File

OTC Skin Bleaching Products

Volume No.	Company	Product
160056	USV Pharmaceutical Corporation Tuckahoe New York   10707	Esoterica Regular, Esoterica Facial, Esoterica Fortified, Esoterica Lotion,  Esoterica Special, Golden Peacock Bleach Cream
160072	Plough, Inc. Memphis , Tenn.    38151	Artra Skin Tone Cream
160081	Chattem Drug & Chemical Co. Chattanooga , Tenn.   37409	Ultra Nadinola Cream, Deluxe Nadinola Complexion Cream, Derma Blanch, Nadinola Double Care Lotion
160112	Nicholas Products Ltd. Waukeska , Wisconsin   53186	Ambi Skin Cream (Vol. I)
160113	Ambi Cosmetics – USA (Animal Safety Data, Part 1)	Hydroquinone (Vol.  II)
160114	Ambi Cosmetics – USA (Animal Safety Data, Part 2)	Hydroquinone (Vol. III)
160115	Ambi Cosmetics – USA (Medical rationale)	Ambi skin cream (Vol. VI)
160116	Ambi Cosmetics – USA (Effectiveness data)	Hydroquinone and Glyceryl – PABA (Vol. V)
160117	Ambi Cosmetics – < USA (Human safety data)	Hydroquinone and Glyceryl – PABA (Vol. IV)
16A294	Skin Bleaching Products— References

Panel Administrator’s File

16APAI—Panel Administrator’s File Volume No. I—Skin Bleaching Products

1. Federal Register call for data
2. List of Panel members and curricula vitae
3. General charge to OTC Drug Products Review Panels
4. Statement of Exemption and Environmental Assessment Report
5. Economic Impact Assessment Statement
6. Minutes of the Miscellaneous External OTC Drug Products Review Panel
7. Correspondence to the FDA staff or Panel on these drug – None

There is no Panel Administrator’s File Volume No. II

Nail Biting and Thumb Sucking Deterrent 

Drug Products Panel Index

Volume No.	Submitted By	Subject
160010	Commerce Drug Co., inc.	Sucrose Octaacetate Isopropyl Alcohol
160020	The Mentholatum Co., Inc.	Sucrose Octaacetate Denatonium Benzoate
160054	Purepac Pharmaceutical Co.	Denatonium Benzoate
160168	Parke Davis & Co.	Sucrose Octaacetate
160172	Parke Davis & Co.	Denatonium Benzoate
160228	Parke Davis & Co.	Denatonium Benzoate
160295 (2 Volume No.s)	International Research and Development Corporation	Denatonium Benzoate

Nail Biting and Thumb Sucking Deterrent

Drug Products Panel Index

Volume No.	Subject
160416	Cited References
160417	Miscellaneous Uncited References

Administrative File
OTC Nail Biting and Thumb Sucking Deterrent Drug Products

Docket No.  80N-0146

Panel Administrator’s File

Volume No.	Contents
16DPA1	Panel Administrator’s File 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 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Camphorated Oil and Camphor-Containing Products Panel Index

Volume No.	Submitted By	Subject
160291	American Pharmaceutical Association	Camphorated Oil
160383	Carmine Varane, Pharmacist	Camphorated Oil

Volume No.	Submitted By	Subject
160222	University of Nebraska Medical Center  Carol R. Angle, MD	Camphor
160358	University of Pennsylvania Hospital  Harry E. Morton, ScD	Camphor

Administrative File

OTC Camphorated Oil and Camphor-Containing Drug Products

Dockets No 80N-0227

Volume No.	Contents
16BPA1	1.0  References 1.10 Call for Data 1.2 List of Panel Members and Liaisons 1.3 Curriculum Vitae of Panel Members and Liaisons 1.4 Index to Panel Submissions 1.5  Regulatory Analysis Assessment 1.6 Summary Minutes of Panel Meetings 1.7 Correspondence File

Miscellaneous External Advisory Review Panel Index 
For OTC Wart Remover Drug Products Submissions

Volume No.	Submitted By	Subject
160004	Whitehall Laboratories, Inc.	Compound W
160007	Commerce Drug Co., Inc.	B-D-B Wart Remover
160282	Whitehall Laboratories, Inc.	Literature References
160283	Whitehall Laboratories, Inc.	Supplemental Data—Studies Pertaining to Salicylic Acid, Glacial Acetic Acid, Acetone Collodion,and Collodion
160287	Daywell Laboratories Corp.	Vergo
160289	Stiefel Laboratories, Inc.	Duofilm
160359	Stiefel Research Institute, Inc.	Duofilm-C
160376	Dr. Mary H. Bunney Royal Infirmary Edinburgh , Scotland , UK	Supplemental Data—Studies Using Salicylic Acid and Lactic Acid
160411		Cited References
160412		Miscellaneous Uncited References

Administrative File

Wart Remover Drug Products for Over-the-Counter Human Use

Docket No.  80N-0238

Panel Administrator’s File

Volume No.	Contents
16CPA1	Panel Administrator’s File 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 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Ingrown Toenail Relief Drug Products Panel Index

Volume No.	Submitted By	Subject
160100	Scholl, Inc.	Sodium Sulfide
160127	Whitehall Laboratories	Chlorobutanol, Tannic Acid, Isopropyl Alcohol
160280	Scholl, Inc.	Sodium Sulfide
160384	Whitehall Laboratories	Chlorobutanol, Tannic Acid, Isopropyl Alcohol
160386	Scholl, Inc.	Sodium Sulfide
160419		Cited References
160420		Miscellaneous Uncited References

Administrative File
OTC Ingrown Toenail Relief Drug Products

Docket No.  80N-0348

Panel Administrator’s File

Volume No.	Contents
16EPA1	Panel Administrator’s File 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 Regulatory Analysis Assessment 1.7  Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Hair Grower and Hair Loss Prevention Drug Products Panel Index

Volume No.	Submitted By	Subject
160118	Edwards Industrial Center, Inc.	Tetracaline Hydrochloride, Benzoic Acid, Ascorbic Acid
160232	Shepard D. Roberts	Lanolin, Wheat Germ Oil, Coconut Oil, Vegetable Olive Oil
160425		Cited References
160426		Miscellaneous Uncited References

Administrative File

OTC Hair Grower and Hair Loss Prevention Drug Products

Docket No.  80N-0357

Panel Administrator’s File

Volume No.	Contents
16FPA1	Panel Administrator’s File 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 Regulatory Analysis Assessment 1.7 Statement of Exclusion from Environmental Assessment 1.8 Summary Minutes of Panel Meetings 1.9 Correspondence File

Corn and Callus Remover Drug Products

Index to OTC Volumes

Volume No. No.	Submitted By	Products/Subject
160003	Whitehall laboratories	Freezone
160073	Chattem Drug & Chemical Co.	Blis-To-Sol
160079	E.G. Behren	Corn Callus Remover
160097	Scholl, Inc.	“2” Drop Corn/Callous Remover, Callous Salve, Corn Salve, Halluxol, Onixol and Corn and Callous Products
160098	Scholl, Inc.	Same as 160097
160099	Scholl, Inc.	Same as 160097
160100	Scholl, Inc.	Same as 160097
160101	Scholl, Inc.	Same as 160097
160133	Whitehall Laboratories	Freezone
160256	Scholl, Inc.	A report on “Outpatient Utilization of ICPM Foot Clinic”
160282A & B	Whitehall Laboratories	Salicylic acid
160283	Whitehall Laboratories	Zinc chloride, salicylic acid, and acetic acid
160285	Scholl, Inc.	Salicylic acid
160292	Combe, Inc.	Blue Jay Corn Plasters
160293	Scholl, Inc.	40 percent salicylic acid disks
160294	Combe, Inc.	Phenoxyacetic acid
160380	Scholl, Inc.	Salicylic acid
160398	Combe, Inc.	Phenoxyacetic acid
16IPA1-A		Cited References
16IPA1-B		Uncited References

Administrative File

OTC Corn and Callus Remover Drug Products

Docket No. 81N-0122

Panel Administrator’s File

Volume No.	Contents
16IPA1	1.1 Call to 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

Topically Applied Hormone-Containing Drug Products

Index of OTC Volumes

(Docket No.  81N-0144)

Volume No.	Submitted By	Products/Subject
160055	Sterling Drug, Inc. New York , NY   10016	Satura Moisture Cream with Hormones; Satura Moisture Lotion with Hormones; Moisturing Hormone Hand Cream; Cellogen Moisturing Hormone Cream with Protein Hydrolysate
160057	USV Pharmaceutical Corporation Tuckahoe , NY   10707	Hormonex Beauty Serum; Hormonex in Cream; Hormonex hair and Scalp Serum
160095	Helena Rubinstein New York , NY   10022	Ultra Feminine Cream with Natural Estrogen and Progesterone; Ultra Feminine beauty Oil with Natural Estrogen and Progesterone
160195	FDA, Bureau of Drugs Office of Compliance	Information to the Panel regarding potential hazard of topical skin and hair preparations containing various hormones.
16GPA1-A		Cited References

Administrative File
Topically Applied Hormone-Containing Drug Products For Over-The-Counter Human Use

(Docket No.  81N-0144)
Panel Administrator’s File

Volume No.	Contents
16GPA1	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

Pediculicide Drug Products for OTC Human Use 
Index of OTC Volumes
(Docket No.  81N-0201)

Volume No.	Submitted By	Products/Subject
160011	Commerce Drug Company, Inc.	BARC Cream and Liquid
160046	Norcliff laboratories, Inc.	A-200 Pyrinate Liquid and Gel
160075	Block Drug Company, Inc.	Dolex Gel and Foaming Liquid
160092	McKesson laboratories	A-200 Pyrinate Liquid and Gel
160094	Norcliff Laboratories, Inc.	Kerosene
160130	FMC Corporation	Efficacy data on piperonyl butoxide—pediculosis control.
160137	Pfizer Pharmaceuticals, Inc.	RID
160138	Pfizer Pharmaceuticals, Inc.	RID
160163	Pfizer Pharmaceuticals, Inc.	RID
160202	Norcliff Thayer, Inc.	A-200 Pyrinate Liquid and Gel
160217	Block Drug Company, Inc.	Dolex
160220	Block Drug Company, Inc.	Dolex
160227	Pfizer Pharmaceuticals, Inc.	RID
160264	Fairfield American Corporation	A-pyrenone—pediculosis control
160279	Pfizer Pharmaceuticals, Inc.	RID
160360	Pfizer Pharmaceuticals, Inc.	RID
160400	Norcliff Thayer, Inc.	A-200 Pyrinate Liquid and Gel
160403	Laboratories Applipharm SA	PARA-2
16KPAI-A		Cited References
16KPAI-B		Uncited References

Administrative File

Pediculicide Drug Products For

OTC Human Use

Docket No. 81N-0201

Panel Administrator’s File

Volume No.	Contents
16KPAI	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

Boil Ointment Drug Products for OTC Human Use

Index to OTC Volumes

(Docket No. 82N-0054)

Volume No.	Submitted By	Products/Subject
160005	Commerce Drug, Co., Inc.	Boil-Ease
160182	Bowman Pharmaceuticals, Inc.	Bowman Drawing Paste
160214	Press Chemical and Pharmaceutical Laboratories, Inc.	Epsal Ointment
16LPA1-A		Cited References

Administrative File

Boil Ointment Drug Products for OTC Human Use

Docket No. 82N-0054

Volume No.	Contents
16LPA1	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 Drug Products for the Treatment of Diaper Rash

Part I

Docket No.  78N-0301

Index to OTC Volumes

Volume No.	Submitted by	Marketed Products/Subject
160021	Pfizer Pharmaceuticals	Desitin Ointment
160025	Corona Manufacturing Co.	Corona Ointment
160027	Warren-Teed Pharmaceuticals, Inc.	Taloin Diaper Rash Ointment
160028	The UpJohn Co.	Clocream Skin Cream
160038	Milies Laboratories, inc.	Acid Mantle Cream, Acid mantle Lotion
160040	Resinol Chemical Co.	Resinol Ointment, Resinol Greaseless Cream
160041	Macsil, Inc.	Balmax Ointment
160042	Syntex laboratories, Inc.	Methakote Diaper Rash Crème
160053	Chesebrough-Pond’s, Inc.	Vaseline Pure Petroleum Jelly
160067	Block Drug Co. Ic.	Tashan Super Skin Cream
160069	Cooper Laboratories, Inc.	Aveeno Colloidal Oatmeal
160070	Cooper Laboratories, Inc.	Aveeno Colloidal Oatmeal
160077	Bristol Myers Co.	Ammens Powder
160088	Macsil, Inc.	Balmax Powder
160091	Bristol Myers Co.	Ammens Powder
160104	USV Pharmaceutical Corp.	Panthoderm Cream, Panthoderm Lotion
160204	USV Pharmaceutical Corp.	Panthoderm Cream Panthoderm Lotion
160221	Corona manufacturing Co.	Corona Ointment
160236	Pennwalt Corp.	Caldesene powder, Caldesene Ointment, Proposed Product Containing Calcium Undecylenate and Hydrocortisone Acetate
160242 through 160247	Sterling Drug Inc.	Diaparene ointment, Diaparene peri Anal, Diaparene Baby Lotion, Diaparene Medicated Baby Powder, Diaparene Diaper rinse Solution, Diaparene Diaper Rinse Tablets, Diaparene Diaper Rinse Granules
160271	Whitehall Laboratories, inc.	Sperti Healing Ointment
160272	Whitehall Laboratories, Inc.	Sperti Healing Ointment
160277	American Home Products Corp.	Sperti Healing Ointment
160357	Stiefel Laboratories, Inc.	Zeasorb Super Absorbent Medicated Powder
160362	University of Pennsylvania	Corn Starch Study
160421	Macsil, Inc.	Balmax Ointment
160427	Glenbrook laboratories	Cornstarch Study

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 I

Statement on OTC Drug Products

For the Treatment of Diaper Rash

Docket No.  78N-0301

Panel Administrator’s File

Volume No.	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 III

Docket No.  78N-0301

Index to OTC Volumes

Volume No. No.	Submitted By	Product
160103	Unimed, Inc.	Residerm (Poison Ivy Lotion)
160132	Marion Health and Safety, Inc.	Zircreme,. Ferric Chloride, Sting-Kill
160152	Marion Health and Safety, Inc.	Poison Ivy Wash

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 No.	Sumitted By	Product
160001	Frederick Damrau, MD	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 No.	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 No.	Submitted By	Marketed Products/Subject
160022	Marion Laboratories Inc.	Bluboro Powder
160038	Dome Laboratories	Acid Mantle, Crème, Lotion
160039	Dome Laboratories	Domeboro Tablets, Powder
160069	Cooper Laboratories, Inc.	Acnaveen Bar, Cream, Aveeno Bar, bath, Oilated Bath, Avenol Bath Additive, BurVeen 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 Medicated 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 Pharmacel, 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 Manufacturig 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 No.	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 No.	Submitted By	Product
160074	Marion Health and Safety, Inc.	Sting Kill Swabs
160119	Tender Corp.	After Bite
160159	Marion Health and Safety, Inc.	Sting Kill Swabs
160434	Tender Corp.	After Bite

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 VI

Statement on OTC Insect Bite Neutralizer Drug Products

Docket No.  78N-0301

Panel Administrator’s File

Volume No.	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 Meetings 1.7 Correspondence 1.8  References

OTC Drug Products for the Control of Dandruff

Saborrheic Dermatitis, and Psoriasis;

Establishment of Monograph

Docket No.  82N-0214

Index to OTC Volumes

Volume No.	Submitted By	Marketed Products/Subject
160033	Denver Chemical Mfg. Co.	Siroil
160042	Syntex Laboratories, Inc.	Methakote
160043	Reed and Carnrick	Tarbonis
160047	Reed and Carnrick	Alphosyl
160050	Reed and Carnrick	Sebical Anti-dandruff Shampoo
160051	Westwood Pharmaceuticals, Inc.	Balnetar
160059	Purex Corp., Ltd	Cuticura medicated Liquid
160060	Purex Corp., Ltd	Cuticura Medicated Ointment
160068	Block Drug Co., Inc.	Terin Cream, Tegrin Foam, Tegrin Medicated Soap
160069	Cooper Laboratories, Inc.	Acnaveen Cream, Packer’s Pine Tar Liquid Shampoo, Packer’s Pine Tar Soap, Sebaveen
160070	Cooper Laboratories, Inc.	Supplemental data
160087	Westwood Pharmaceuticals, Inc.	Supplemental data
160129	Whitehall Laboratories	Oxipor VHC Lotion
160134	Whitehall Laboratories	Denorex Medicated Gel Shampoo, Denorex Medicated Liquid Shampoo
160201	Chester A. Baker Laboratories, Inc.	Baker’s P & S Liquid, Baker’s P & S Ointment
160237	Mitchum-Thayer, Inc.	Mazon Medicated Cream
160238	Mitchum-Thayer, Inc.	Mazon Medicated Soap
160241	Whitehall Laboratories	Oxipor VHC Lotion
160253	Westwoord Pharmaceuticals, Inc.	Estar Therapeutic Tar Gel
160255	H.B. Distributing Co.	Hospital Brand Psoriasis Emulsion
160267	Dr. Zackman	Letter of Communication on coal tar
160275	Warner Lambert Co.	Listerine Antiseptic
160276	Warner Lambert Co.	Listerine Anitseptic
160286	The Proprietary Association	Coal tar Products
160297	Preston Pharmaceuticals, Inc.	Dermakon Dandruff Shampoo
160298/ 160299	Texas Pharmacal Co.	Meted Cream Shampoo, Meted Lotion Shampoo
160300	Armour-Dial, Inc.	Dial Conditioning Dandruff Shampoo for Normal Hair, Dial Conditioning Shampoo for Dry hair, Dial Conditioning Shamposs for Oily Hair
160301	Armour-Dial, Inc.	References
160302	Armour-Dial, Inc.	References
160303	Armour-Dial, Inc.	References
160304	Procter and Gamble	Head and Shoulders
160305	Mitchum-Thayer, Inc.	Mitchum Dandruff Shampoo
160306	Max Factor	Sebb Lotion
160307	Mitchum-Thayer, Inc.	Mazon Medicated Shampoo
160308	H. Clay Glover Co., Inc.	Glover’s Imperial Scarcoptic Mange Medicine
160309	H. Clay Glover Co., Inc.	Glover’s Imperial Medicated Soap
160310	H. Clay Glover Co., Inc.	Glover’s Imperial Medicated Ointment
160311	Marion Laboratories, Inc.	Metasep Medicated Shampoo
160312	Olin Corp.	Zinc Omadine
160313	Flow Pharmaceuticals	Nu-Flow
160314	Alcon Laboratories, Inc.	Ionil, Ionil-T
160315	Whitehall Laboratories	Denorex Medicated Liquid Shampoo
160316	G.S. Herbert Laboratories	Vanseb Dandruff Shampoo, Vanseb-T Tar Shampoo
160317	Hess Hair Milk Laboratories, Inc.	Hess Hair Milk
160318	Texas Pharmacal Co.	Meted-2 Cream Shampoo, Meted-2 Lotion Shampoo
160319	Sterling Drug, Inc.	Cradol
160320	Sterling Drug, Inc.	Methylbenzethonium chloride
160321	Sterling Drug, Inc.	Double Danderine
160322	Sterling Drug, Inc.	Phisoden
160323	Westwood Pharmaceuticals, Inc.	Sebulex Conditioning Shampoo
160324	Westwood pharmaceuticals, Inc.	Foxtex Cream
160325	Westwood Pharmaceuticals, Inc.	Sebutone AntiSEBORRHEIC Tar Shampoo
160326	R. Schattner Co., Pharmaceuticals	Chloraderm
160327	Smith, Kline, and French Laboratories	Pragmatar
160328	H. Clay Glover Co., Inc.	Supplemental data Glover’s Imperial Medicated Soap
160329	H. Clay Glover Co., Inc.	Supplemental data Glover’s Imperial Medicated Ointment
160330	H. Clay Glover Co., inc.	Supplemental data Glover’s Imperial Sarooptic Mange Medicine
160331	Purdue Frederick Co.	Betadine Shampoo
160332	Colgate-Palmolive	Grenadier Dandruff Control hair Groom, Wildroot Dandruff Treatment hair Groom
160333	Colgate-Palmolive	Look Twice Anti-dandruff Shampoo
160334	Colgate-Palmolive	Look Twice Anti-dandruff Shampoo
160335	Colgate-Palmolive	Safety and efficacy of zinc pyrithione
160336	Colgate-Palmolive	Supplemental data
160337	Colgate-Palmolive	Supplemental data
160338	H. Clay Glover Co., Inc.	Supplemental data Glover’s Imperial Medicated Soap
160339	Block Drug Co., Inc.	Tegrin Medicated Shampoo
160340	Helene Curtis Industries, Inc.	Enden Lotion Shampoo
160341	American Cyanamid Co.	Bibliography of omadines
160342	Penwalt Corp.	Hydrocortisone acetate and calcium undecylenate
160343	Hask, Inc., Toiletries	Hask D.S.T. Treatment Shampoo
160344	Hask, Inc. Toiletries	Hask Hair and Scalp Treatment
160345	h. Clay Glover Co., Inc.	Rewocid SBU 185
160346	Gillette Medical Evaluation Laboratories	Safety and efficacy of zinc omadine
160347	Texas Pharmacal Co.	Pentrax Tar Shampoo
160348	Texas Pharmacal Co.	Supplemental data
160349	Gillette Co.	Selenium sulfide
160350	R.T. Vanderbilt Co., inc.	Vancide 89 RE
160351	Helene Curtis Industries, Inc.	Suave Dandruff Shampoo
160352	Alberto-Culver Co.	Rinse Away Dandruff Rinse
160353	Warner-Lambert Co.	Listerine Antiseptic
160355	US Borax Research	Toxicity of Boric acid and sodium tetraborate
160356	Westwood Pharmaceuticals, Inc.	Sebulex Conditioning Shampoo
160363	Abbott Laboratories	Selsun Blue for Normal Hair, Selsun Blue for Dry Hair, Selsun Blue for Oily Hair
160364	Stiefel laboratories, Inc.	Polytar Shampoo
160365	Block Drug Co., inc.	Hydrocortisone alcohol and coal tar extract
160366	Olin Corp.	Toxicological summary of zinc omadine
160367	Olin Corp.	Bibliography I
160368	Olin Corp.	Bibliography II
160369	Procter & Gamble	Safety and efficacy of zinc pyrithione
160370	Procter and Gamble	References 1-25
160371	Procter and Gamble	References 26-50
160372	Procter and Gamble	References 51-75
160373	Procter and Gamble	References 76-100
160374	Procter and Gamble	References 101-121
160375	Westwood Pharmaceuticals, Inc.	Supplemental data Estar Gel
160378	Avon Products, Inc.	Keep Clear Anti-dandruff Shampoo
160379	Mitchum-Thayer, Inc.	Mazon Medicated Cream
160381	The Proprietary Association	Coal tar Products
160385	Abbott Laboratories	Safety and evaluation o selenium sulfide
160387	Block Drug Co., inc.	Tegrin Shampoo
160389	Procter and Gamble	Supplemental data Head and Shoulders
160390	National Cancer Institute	Bioassay of Selsun for Possible Carcinogenicity
160392	Beecham Products, Inc.	Zinc pyrithione anti-dandruff hairgroom
160393	R.T. Vanderbilt Co., inc.	Supplemental data Vancid 89 RE
160394	Emery Uncommon Chemicals	Undeclenic acid monoethanolamide sulfosuccinate, sodium salt
160395	Purdue Frederick Co.	Supplemental data Betadine Shampoo
160397	Westwood Pharmaceuticals, Inc.	Sebucare Scalp Lotion, Supplemental data
160401	Helene Curtis Industries, inc.	Supplemental data Enden lotion Shampoo
160402	Emery uncommo Chemicals	Ogilvie Dandruff Shampoo
160404	Plough, Inc.	Sulfur-8 Hair and Scalp Conditioner
160405	Helene Curtis Industries, Inc.	Validation of the IBT Study Suave Dandruff Shampoo
160406	Neutrogena Corp.	T-Gel Shampoo
160407	Stiefel Laboratories, Inc.	Polytar Bath
160408	H.B. Distributing Co.	Hospital Brand Psoriasis Emulsion
160410	Hask, Inc., Toiletries	Letter of communication
160414	Westwood Pharmaceuticals, inc.	Supplemental data
160418	The proprietary Assocaition	Coal tar project
160430	Whitehall Laboratories	Coal tar lotions
160431	The Proprietary Association	Coal tar project
160432	National Psoriasis Foundation	Coal tar
160436	Dr. R.B. D’Agostino	Statistical evaluation

Administrative File
OTC Drug Products for the Control of Dandruff, Dermatitis, Seborrheic, and Psoriasis

Establishment of a Monograph

Published in the FEDERAL REGISTER of December 3, 1982 (47 FR 54646)

Docket No.  82N-0214

Panel Administrator’s File

Volume No.	Contents
16MPA1             16MPA1-A 16MPA1-B	1.1 Call for Data 1.2 List of panel Members and Liaisons 1.3 Curriculum Vitae of panel Member and liaisons 1.4  General Charge to Panel 1.5 Index to Panel Submissions 1.6p Minutes of Panel Meetings 1.7  Correspondence 1.8  Cited References 1.9 Uncited References

NO_______TFM_____________ Volume No. WAS MADE FOR__Naibiting and____________________

 

__thumbsucking Deterrent Drug_Products    _________________________________________________

 

 

NO_____TFM_____________ Volume No. WAS MADE FOR____Wart Remover________________

 

 

_Drug Products       _________________________________________________________________

 

 

TFM Volume No.____16ATFM________________________________

 

Has been established for__Skin Bleaching Drug Products___________________________________

_____

 

TFM Volume No.______16BTFM_____________________

 

 

Has been established for__Hair Grower and hair Loss Prevention Drug Products________ 

 

_____

TFM Volume No.____16ETFM_______________________

 

Has been established for____Ingrown Toenail Drug Products_______________________________________

 

 

FR Volume No.__16BFR____________________

 

 

Has been established for____Camphorated Oil Drug Products_____________________________