Regulatory Information
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OTC Panel Submissions (Indices Only): 06- Topical Analgesic (Part 2)
Public Administrative File OTC External Analgesic Drug Products (Docket # 78N-0301)
| Volume | Submitted By | Subject |
|---|---|---|
| 060005* | Monsanto Industrial Chem. Co. | Methyl salicylate |
| 060007-B | E.R. Squibb & Sons, Inc. | Counterpain Rub |
| 060008 | Wm. P. Poythress | Panalgesic |
| 060009 | Yager Drug Co. | Yager’s Liniment |
| 060011 | Gebauer Chemical Co. | Gebauer’s Tannic Spray |
| 060012 | Ciba-Geigy, Inc. | Nupercainal Cream, etc. |
| 060013 | Ciba-Geigy, Inc. | Nupercainal Cream, etc. |
| 060014 | Brown Medicine Co. | Brown’s N & B Liniment |
| 060015 | Carbisulphoil Co. | Foille Liquid & Ointment |
| 060016 | Carbisulphoil Co. | Foille Liquid & Ointment |
| 060017 | C. G. Smith Products Co. | Gypsy Rub Liniment |
| 060017 | Geriatric Pharm Co. | Ger-O-Foam |
| 060017 | Wade Chemical Corp. | Jim Wade Deep Treet Liniment |
| 060017 | Berry & Withington Co. | Analgesic Balm |
| 060017 | Meyer Brothers Drug Co. | Bet-U-Lol |
| 060020 | Astra Pharm. Products Inc. | Xylocaine Ointment |
| 060022 | The Mentholatum Co. | Mentholatum Deep Heating Lotion |
| 060023 | The Mentholatum Co. | Mentholatum Deep Heating Rub |
| 060024 | Warren-Teed Pharm., Inc. | Myoflex Cream |
| 060025 | The Dow Chemical Co. | Creme Dyclone |
| 060026 | Smith, Kline & French Labs | Quotane Lotion, etc. |
Sequential volume numbers not on this list are already on file with the Hearing Clerk,
as follows:
OTC Topical Otic Drug Products, Docket No. 77N-0334,
OTC Skin Protectant Drug Products, Docket No. 78N-0021,
OTC Sunscreen Drug Products, Docket No. 78N-0038
| Volume | Submitted By | Subject |
|---|---|---|
| 060027 | Whitehall Labs, Inc. | Outgro |
| 060029 | Whitehall Labs, Inc. | Instant Heet Spray |
| 060030 | Whitehall Labs, Inc. | Heet Analgesic Liniment |
| 060031 | Whitehall Labs, Inc. | Heet Gel |
| 060032 | Whitehall Labs, Inc. | Anbesol |
| 060033 | Whitehall Labs, Inc. | Infrarub |
| 060035 | W. F. Young, Inc. | Asborbine, Jr. |
| 060036 | W. F. Young, Inc. | Absorbine Arthritic Pain Lotion |
| 060038 | Resinol Chemical Co. | Resinol Ointment, Cream |
| 060039 | Abbott Labs | Butesin Picrate Ointment |
| 060040 | Warner-Lambert Research Institute | Sloan’s Liniment, Balm |
| 060041 | Norwich Pharmacal Co. | Unquentine Aerosol |
| 060042 | Norwich Pharmacal Co. | Unquentine Ointment |
| 060043 | Norwich Pharmacal Co. | Unquentine Plus |
| 060045 | Abbott Labs | Tronothane HCl |
| 060046 | Pfizer, Inc. | Un-Burn |
| 060047 | Sterling Drug, Inc. | Pontocaine Cream |
| 060048 | Sterling Drug, Inc. | Pontocaine Ointment |
| 060049 | Sterling Drug, Inc. | Medi-Quick |
| 060050 | Denver Chemical Mfg. Co. | Dencorub |
| 060051 | Plough, Inc. | Musterole |
| 060052 | Denver Chemical Mfg. Co. | Antiphlogistine |
| 060053 | Sterling Drug, Inc. | Campho-Phenique |
| 060054 | Denver Chemical Mfg. Co. | Pain Away |
| 060055 | Plough, Inc. | Solarcaine Cream, etc. |
| 060056 | Pfizer, Inc. | Ben-Gay Ointment - Lotion |
| 060058 | Combe, Inc. | Lanacane Spray |
| 060059 | Combe, Inc. | Soak’n Massage |
| 060060 | Combe, Inc. | Lanacane Cream |
| 060061 | Medical Supply Co. | MSCo Burn Compound, etc. |
| 060062 | Quist Chemical Co. | A’MAY’S-On Ointment |
| 060063 | Enegoltaria Medicine Co. | Linimento Daire, etc. |
| 060068 | Ciba Pharmaceutical Co. | Pyribenzamine Cream, etc. |
| 060071 | Plough, Inc. | Dermasol Cream, Foam, Lotion |
| 060073 | Arnar-Stone Labs, Inc. | Americaine Sun Balm, etc. |
| 060074 | The R. Schattner Co. | Oraderm, etc |
| 060075 | Sperti Drug Products | Aspercreme |
| 060077 | Block Drug Co., Inc. | Omega Oil |
| 060080-B | Calhoun’s Laboratory | Burn-O-Jel |
| 060082 | M. S. Glorius Co. | Glourius Pain Relief |
| 060085 | Noxell Corp. | Noxzema Skin Cream |
| 060087 | W. F. Young, Inc. | Absorbine Jr.-additional data |
| 060092 | Whitehall Labs, Inc. | Infrarub-additional data |
| 060094 | Carbisulphil Co. | 8-hydroxyquinoline |
| 060095 | Parke, Davis & Co. | Benadryl, etc. |
| 060096 | Noxell Corp. | Noxzema-additional data |
| 060097 | Plough, Inc. | Hydrocortisone preparations |
| 060098 | Plough, Inc. | Hydrocortisone preparations |
| 060099 | Plough, Inc. | Hydrocortisone preparations |
| 060100 | Plough, Inc. | Hydrocortisone preparations |
| 060101 | Plough, Inc. | Hydrocortisone preparations |
| 060102 | Plough, Inc. | Hydrocortisone preparations |
| 060106 | Ciba-Geigy, Inc. | Vioform-Hydrocortisone |
| 060107 | Ciba-Geigy, Inc. | Vioform-Hydrocortisone |
| 060108 | Ciba-Geigy, Inc. | Vioform-Hydrocortisone |
| 060111 | Plough, Inc. | Musterole, etc. |
| 060118 | C. F. Kirk Labs | Exocaine-additional data |
| 060119 | Rexall Drug Co. | Thru, Intracel |
| 060121 | C. F. Kirk Labs | Exocaine-additional data |
| 060122 | Dermik Labs | Hydrocoortisone comments |
| 060123-B | Bowman Pharm., Inc. | Liquid Analgesic, etc. |
| 060124 | American Academy of Dermatology | Report on Hydrocortisone |
| 060126 | C. F. Kirk Labs | Exocaine-additional data |
| 060127 | Pfizer, Inc. | Ben-Gay-additional data |
| 060132 | C. F. Kirk Labs | Additional data |
| 060133 | Reed & Carnrick Pharmaceuticals | Tarcortin |
| 060136 | C. F. Kirk Labs | Additional data |
| 060138 | Beecham Products (formerly Calgon) | S.T. 37 |
| 060139 | Beecham Products (formerly Calgon) | S.T. 37 |
| 060140 | Beecham Products (formerly Calgon) | S.T. 37 |
| 060141 | Eli Lilly & Co. | Surfadil |
| 060142 | Eli Lilly & Co. | Surfacaine |
| 060144 | Warren-Teed Pharm., Inc. | Myoflex-additional data |
| 060146 | Sterling Drug, Inc. | Additional data |
| 060150 | Miscellaneous submissions to the Panel | |
| 060152 | Otic Clapp & Sons | Obtundia, etc. |
| 060153 | Carol Angle, M.D. | Comment on camphor |
| 060156 | B. F. Ascher & Co. | Mobisyl Creme |
| 060161 | The Upjohn Co. | Hydrocortisone literature |
| 060173 | W. F. Young, Inc. | Absorbine Jr.-Supplement |
| 060174 | W. F. Young, Inc. | Absorbine Jr.-Supplement |
| 060178 | FDA | Hydrocortisone data search-viral infections |
| 060179 | Arnar-Stone Labs, Inc. | Presentation to Panel on methemoglobinemia and benzocaine |
| 060180 | American Home Products | Statement to the Panel |
| 060186 | References cited in report A-C | |
| 060187 | References cited in report D | |
| 060188 | References cited in report E-G | |
| 060189 | References cited in report H-L | |
| 060190 | References cited in report M-P | |
| 060191 | References cited in report Q-S | |
| 060192 | References cited in report T-Z | |
| 060193 | References evaluated but not cited in report A-B | |
| 060194 | References evaluated but not cited in report C-D | |
| 060195 | References evaluated but not cited in report E-G | |
| 060196 | References evaluated but not cited in report H-L | |
| 060197 | References evaluated but not cited in report M-R | |
| 060198 | References evaluated but not cited in report S-Z | |
| 060199 | Abstracts of Bibliography - Topical Analgesic ingredients | |
| 060202 | Miles Laboratories, Inc. | Cort-Dome Hydrocortisone |
| 060203 | Miles Laboratories, Inc. | Cort-Dome Hydrocortisone |
| 060204 | Miles Laboratories, Inc. | Cort-Dome Hydrocortisone |
| 06BPA1 | Panel Administrator’s File, Volume I - General | |
| 06BPA2 | Panel Administrator’s File, Volume II - Meeting Summary Minutes | |
| 06BPA3 | Panel Administrator’s File, Volume III - Correspondence File (1972, 1973) | |
| 06BPA4 | Panel Administrator’s File, Volume IV - Correspondence File (1974, 1975) | |
| 06BPA5 | Panel Administrator’s File, Volume V - Correspondence File ( 1976, 1980) |
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