• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Regulatory Information

  • Print
  • Share
  • E-mail

OTC Panel Submissions (Indices Only): 16 - Miscellaneous External

External Analgesic Drug Products For OTC Human Use
OTC Drug Products for the Treatment of Diaper Rash
Part I
Docket No. 78N-0301
Index to OTC Volumes

Volume 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 Miles Laboratories, Inc. Acid Mantle Crème, Acid Mantle Lotion
160040 Resinol Chemical Co. Resinol Ointment, Resinol Greaseless Cream
160041 Macsil, Inc. Balmex Ointment
160042 Syntex Laboratories, Inc. Methakote Diaper Rash Crème
160053 A&B Chesebrough-Pond’s, Inc. Vaseline Pure Petroleum Jelly
160067 Block Drug Co., Inc. 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. Balmex Ointment
160091 Bristol Myers Co. Ammens Powder
160104 USV Pharmaceutical Corp. Pathoderm 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. Balmex Ointment
160427 Glenbrook Laboratories Cornstarch Study

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 Manidn 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 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 Drug Products for the Treatment of Fever Blisters
Part III
Docket No. 78N-0301
Index to OTC Volumes

Volume 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. Campho-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

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 Subject
6BPA8

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 Submission

1.6    Minutes of Panel Meetings

1.7    Correspondence

1.8    References

Administrative File
Alcohol Products For Topical
Antimicrobial OTC Human Use
Docket No 75N-0183
Panel Administrator’s File

Volume Subject
16JPA1

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

Mercury-Containing Drug Products 
For Topical Antimicrobial OTC Human Use
Index of OTC Volumes
Docket No. 75N-0183

Volume Submitted By Subject
160025 Corona Manufacturig Co. Parachlormercuriphenol
160085 Hynson, Westcott & Dunnig, Inc. Merbromin
160154 Marion Health and Safety, Inc. Merbromin
160157 Marion Health and Safety, Inc. Thimerosal
160160 Marion Health and Safety, Inc. Orthohydroxyphenyl mercuric chloride
160188 Bowman Pharmaceuticals, Inc. Ammoniated mercury
160189 Bowman Pharmaceuticals, Inc. Thimerosal
160224 Hynson, Westcott & Dunning, Inc. Merbromin
160235 Corona Manufacturing Co. Merbromin
160240 Eli Lilly and  Co. Thimerosal
160270 Hynson, Westcott & Dunnig, Inc. Merbromin
160271 Whitehall Laboratories Phenylmercuric Nitrate
16HPA1-A   Cited References
16HPA1-B   Miscellaneous Uncited References

Administrative File
OTC Mercury-Containing Drug Products for
Topical Antimicrobial Use
Docket No. 75N-0183
Panel Administrator’s File

Volume Subject
16HPA1

1.1    Call for Data

1.2    List of Panel Members and Liaisons

1.3    Curriculum Vitae of panel Members nd Liaisons

1.4    General Charge to Panel

1.5    Index to Panel Submissions

1.6    Minutes of Panel Meetings

1.7    Correspondence

Alcohol Drug Products for Topical Antimicrobial
OTC Human Use
Index to OTC Volumes
(Docket No. 75N-0183)

Volume Submitted By Products/Subject
160045 Parke, Davis & Company Lavacol
160084 Sea Breeze Laboratories, Inc. Sea Breeze
160107 Cramer Products, Inc. Fung-O-Spray
160148 Marion Health and Safety, Inc. Isopropanol Sepps 70/10
160155 Marion Health and Safety, Inc. Isopropanol 70 percent
160173 Holland Rantos Company, Inc. Steri Wipe Alcohol Swabs
160184 Bowman Pharmaceuticals, Inc. Isopropyl alcohol 70 percent
160185 Bowman Pharmaceuticals, Inc. Isopropyl alcohol 91 percent
160206 Holland Rantos Company, Inc. Ethylene Oxide in 70 percent Isopropyl alcohol
160207 Eli Lilly and Company Isopropyl alcohol 91 percent
160209 Eli Lilly and Company Isopropyl alcohol 91 percent
160249 Cramer Products, Inc. Nitrotan
160250 Cramer Products, Inc. Nitrotan (Aerosol)
160251 Cramer Products, Inc. Iso-Quin
160278 Whitehall Laboratories, Inc. Anbesol
160377 Vestal Laboratories Alcare
160382 Vestal Laboratories Alcare
16JPA1-A   Cited References
16JPA1-B   Uncited References

Top