Regulatory Information
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 |