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Regulatory Information

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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
Panel Submission on OTC Miscellaneous External Drug Products Containing Camphor
Regarding Re-opening of Record for
External Analgesic 78N-0301; Anorectal Drug Products 80N-0050; and Cough-Cold 76N-0052
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_____________________________