Regulatory Information
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OTC - Panel Submissions (Indices Only): 07 - Antimicrobial II
PUBLIC ADMINISTRATIVE FILE
TOPICAL ANTIFUNGAL VOLUMES
| VOLUME | COMPANY | PRODUCT OR SUBJECT |
|---|---|---|
| 070001 | Wade Chemical Corp. | Jim Wade Foot Powder |
| 070004 | Laboratory Robaina, Inc. | Acetolia Robaina |
| Givaudan Corp. | G-4 (Dichlorophen) | |
| 070010 | Schering Corp. | Tinactin Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin Solution Aerosol |
| 070017 | Norwich Pharmacal Co. | NP-27 Cream |
| 070018 | Norwich Pharmacal Co. | NP-27 Liquid |
| 070019 | Norwich Pharmacal Co. | NP-27 Aerosol |
| 070020 | Norwich Pharmacal Co. | NP-27 Powder |
| 070022 | Pennwalt Corp. | Cruex Medicated Spray-On Powder |
| 070024-25 | Pennwalt Corp. | Desenex Ointment, Desenex Powder, Desenex Solution, Desenex Spray-On Powder |
| 070029 | Pennwalt Corp. | Cruex Medicated Spray-On Powder |
| 070032 | Wyeth Laboratories, Inc. | Sopronol Ointment, Sopronol Powder, Sopronol Solution |
| 070033 | Dermik Laboratories, Inc. | Two articles on coal tar |
| 070034 | William H. Rorer, Inc. | Carfusin |
| 070042 | W.F. Young, Inc. | Absorbine Athlete’s Foot Powder |
| 070043 | W.F. Young, Inc. | Absorbine Jr. |
| 070045 | La Wall & Harrisson, Inc. | Ecco Medicated Powder |
| 070057 | Upjohn Co. | Medicated Foot Powder |
| 070058 | Upjohn Co. | Fluid Salicresin |
| 070065 | R.L. Gaddy | Ez-It |
| 070066 | Red Foot Products | Red Foot Powder |
| 070068 | Ciba-Geigy Corp. | Vioform Cream, Vioform Ointment, Vioform Powder |
| 070085 | Texas Pharmacal Co. | Verdefam Cream, Verdefam Solution |
| 070087 | Ayerst Laboratories | Enzactin Aerosol, Enzactin Cream, Enzactin Powder |
| 070095 | U.S. Borax | Article on borax and boric acid |
| 070100 | Schuylkill Chemical Co. | Articles on alcloxa, allantoins |
| 070101 | R. Schattner Co. | Chloraderm |
| 070107 | Magnesia Products, Inc. | Sporodyne |
| 070108 | Smith, Kline & French Laboratories | Pragmatar |
| 070134 | Chattem Drug & Chemical Co. | Blis-To-Sol Aerosol Powder, Blis-To-Sol Liquid, Blis-To-Sol Medicated Gel, Blis-To-Sol Powder |
| 070135 | Scholl, Inc. | Solvex Athlete’s Foot Powder |
| 070136 | Scholl, Inc. | Solvex Athlete’s Foot Spray Powder |
| 070137 | School, Inc. | Solvex Athlete’s Foot Spray |
| 070138 | Scholl, Inc. | Solvex Athlete’s Foot Liquid |
| 070139 | School, Inc. | Solvex Athlete’s Foot Ointment |
| 070140 | Carbisulphoil Co. | Articles on sulfur |
| 070141 | Pennwalt Corp. | Calcium undecylenate/hydrocortisone acetate cream |
| 070146 | Rystan Co., Inc. | Prophyllin Ointment, Prophyllin Powder |
| 070147 | Plough, Inc. | Aftate Gel, Aftate Powder, Aftate Spray Liquid, Aftate Spray Powder |
| 070148 | Cramer Products, Inc. | Fung-O-Spray |
| 070151 | Cramer Products, Inc. | Cramer Foot Ointment |
| 070152-4 | Ciba-Geigy Corp. | Vioform-Hydrocortisone Cream, Vioform-Hydrocortisone Liquid, Vioform-Hydrocortisone Mild Cream, Vioform-Hydrocortisone Mild Ointment, Vioform-Hydrocortisone Ointment |
| 070157 | Schering Corp. | Tinactin Powder, Tinactin Powder Aerosol |
| 070158 | Pennwalt Corp. | Desenex |
| 070160 | Ciba-Geigy Corp. | Vioform-Hydrocortisone |
| 070161 | Buckman Laboratories, Inc. | Buderma First Aid Ointment |
| 070162 | Gillette Co. | Foot Guard Foot Powder |
| 070163-4 | Gillette Co. | Foot Guard Foot Deodorant Spray |
| 070165 | Wyeth Laboratories, Inc. | Sopronol |
| 070169 | Texas Pharmacal Co. | Verdefam |
| 070170-1 | Norcliff Thayer Inc. | Tolindate |
| 070177 | Schering Corp. | Tinactin Cream, Tinactin Powder, Tinactin Powder Aerosol, Tinactin Solution, Tinactin Solution Aerosol |
| 070178 | R. Schattner Co. | Studies on phenol |
| 070179 | Ciba-Geigy Corp. | Letter regarding new data on Vioform, Vioform-Hydrocortisone |
| 070180 | Givaudan Corp. | Dichlorophen safety study |
| 070182 | Clairol Research Laboratories | Resorcinol toxicity studies |
| 070183 | Johnson & Johnson | Talc report |
| 070184 | Warner-Lambert Co. | Review of methyl salicylate safety and effectiveness |
| 070185 | Johnson & Johnson | Article on talc |
| 070186 | Otis Clapp & Son, Inc. | Obtundia Antiseptic Swab Pads, Obtundia First Aid Spray |
| 070189 | Pennwalt Corp. | Desenex |
| 070190 | W.F. Young, Inc. | Absorbine Athlete’s Foot |
| 070192 | Otis Clapp & Son, Inc. | Obtundia Surgical Dressing |
| 070193 | Ciba-Geigy Corp. | Vioform, Vioform-Hydrocortisone |
| 070194-5 | Ferro Corp. | Chloroxylenol safety and effectiveness |
| 070196 | W.F. Young, Inc. | Chloroxylenol safety and effectiveness |
| 070197 | Ferro Corp. | Chloroxylenol |
| 070198 | Pennwalt Corp. | Prophylactic efficacy of undecylenic acid |
| 070200 | Pennwalt Corp. | Chloroxylenol irritation and sensitization studies |
| 070201-2 | Reckitt & Colman | Chloroxylenol safety and effectiveness |
| 070204 A&B | Johnson & Johnson | Miconazole nitrate cream |
| 070208 | Pennwalt Corp. | Chloroxylenol |
| 070209 | Ciba-Geigy Corp. | Vioform, Vioform-Hydrocortisone |
| 070210-1 | W.F. Young, Inc. | Absorbine, Jr. |
| 070212 | Pennwalt Corp. | Denenex |
| 070214 | W.F. Young, Inc. | Absorbine, Jr. statistical data |
| 070215 | Johnson & Johnson | Miconazole nitrate labeling claims |
| 070216 | Schering Corp. | Tolnaftate/nystatin cream |
| 070217 | Johnson & Johnson | Miconazole nitrate/hydrocortisone cream |
| 070219 | Westwood Pharmaceuticals Inc. | Halotex Cream, Halotex Solution |
| 070220-1 | U.S. Borax | Literature review on toxicity of boric acid and sodium tetraborate |
| 070222 | Proprietary Association | Labeling claims |
| 070223 | Johnson & Johnson | Labeling claims |
| 070224 | Proprietary Association | Paper on guinea pig model |
| 070225 | Pennwalt Corp. | Paper on fungicidal testing |
| 070226 | W.F. Young, Inc. | In vivo guinea pig studies |
| 070227 | Ferro Corp. | Chlorooxylenol in vitro data |
| 070228 | Richardson-Merrell, Inc. | Resorcinol safety |
| 070229 | Purdue Frederick Co. | Isodine Athlete’s Foot Solution |
| 070231 | Pennwalt Corp. | Cruex Medicated Cream |
| 070232 | R. Schattner Co. | Letter requesting reclassification of phenol |
| 070233 | Ciba-Geigy Corp. | Vioform, Vioform-Hydrocortisone in vitro data |
| 070237 | Westwood Corp. | Haloprogin Anti-candidal data |
| 070240 | Schering Corp. | Summary of tolnaftate safety |
| 070241 | R. Schattner Co. | Letter on phenol |
| 070243 | Purdue Frederick Co. | Chemistry of povidone-iodine |
| 070246 | Rilox Co. | Geneva Ointment |
| 070247 | Sterling Drug, Inc. | Campho-Phenique Liquid |
| 070249 | Sterling Drug, Inc. | Campho-Phenique Liquid, Campho-Phenique Powder |
| 070251 | Stiefel Laboratories, Inc. | Salicylic Acid and Sulfur Soap |
| 070252 | Schering Corp. | Tolnaftate |
| 070253 | Sterol Controls Co. | Candicidin |
| 070254 | Westwood Pharmaceuticals, Inc. | Halotex |
| 070257 | Schering Corp. | Tinactin |
| 070258 | Purdue Frederick Co. | Povidone-iodine |
| 070265 | Ciba-Geigy Corp. | Iodochlorhydroxyquin |
| 070266 | Pennwalt Corp. | Comments on antifungal report |
| 070267 | Wyeth Laboratories | Caprylate and propionate combinations |
| 070301-307 | Antifungal References, Cited | |
| 070308-310 | Antifungal References, Uncited | |
| 07APA1 | Panel Administrator’s File | Volume I - General |
| 07APA2A&B | Panel Administrator’s File of panel meetings | Volume II - Minutes |
| 07APA3 | Panel Administrator’s File, Correspondence File (1978 - 1982) | Volume IV - |
Docket No. 81N-0114
PUBLIC ADMINISTRATIVE FILE
TOPICAL ACNE VOLUMES
| VOLUME | COMPANY | PRODUCT OR SUBJECT |
|---|---|---|
| 070002 | William P. Poythress & Co. | Bensulfoid Lotion |
| 070004 | Laboratory Robaina, Inc. | Acetolia Robaina |
| 070005 | E.R. Squibb and Sons |
Epi*Clear Antiseptic Lotion 10% Epi*Clear Antiseptic Lotion 5% Epi*Clear Acne Lotion |
| 070006 | Miranol Chemical Co., Inc. | Miranol C2M |
| 070009 | Dermakon Dandruff Shampoo | |
| 070022 | Pennwalt Corp. | Ting Antiseptic Medicated Cream |
| 070030 | Campana Corp. | Cuticura (Cutitone) Acne Cream |
| 070036-7 | Warner Lambert | Listerex Antibacterial Acne Scrub |
| 070038-41 | Vick Divisions Research | Clearasil Regular Tinted, Clearasil Stick Medication, Clearasil Vanishing Formula |
| 070046-47 | Dermakon Medicated Cream | |
| 070048 | USV Pharmaceutical Corp. | Oxy-5 |
| 070053 | Upjohn Co. | Plexion |
| 070056 | Upjohn Co. | Zinc Sulfide Compound Lotio, Improved |
| 070060 | Flow Pharmaceuticals | d-Seb |
| 070070 | Texas Pharmacal Co. | Sulforcin Lotion |
| 070071 | Texas Pharmacal Co. | Sulforcin Base 4% |
| 070072 | Texas Pharmacal Co. | Liquimat |
| 070073 | sterling Drug, Inc. | pHisoAc |
| 070083 | Sterling Drug, Inc. | Stri-dex Medicated Pads |
| 070086 | Texas Pharmacal Co. | Contrablem |
| 070088 | Barnes-Hind Pharmaceuticals |
Komed Acne Lotion Komed Mild Acne Lotion |
| 070089 | Westwood Pharmaceuticals | Fostril |
| 070090 | Westwood Pharmaceuticals | Pernox |
| 070092 | Westwood Pharmaceuticals |
Fostex Cake Fostex Cream |
| 070093 | Westwood Pharmaceuticals | Transact |
| 070096 | Helena Rubinstein, Inc. | Bio-Clear Medicated Cream |
| 070097-99 | Texas Pharmacal Co. |
Persadox Cream Persadox Lotion |
| 070100 | Schuylkill Chemical Co. | Alcloxa, Allantoin |
| 070101 | R. Schattner Co. | Chloraderm |
| 070102-4 | William H. Rorer |
Loroxide Lotion Vanoxide Lotion |
| 070105 | Syntex | Microsyn Acne Lotion |
| 070106 | Fox Pharmacal, Inc. | Aktex |
| 070109 | Smith, Kline, & French |
Acnomel Acne Cake Acnomel Acne Cream |
| 070113 | Stiefel labs |
Sulfoxyl Cream Strong Sulfoxyl Lotion Strong |
| 070124 | Campana Corporation |
Cuticura Acne Cream (Cutitone) |
| 070126 | E.R. Squibb and Sons | Epi*Clear Acne Lotion, Epi*Clear Acne Scrub Cleanser, Epi*Clear Acne Soap, Epi*Clear Squibb Acne Kit |
| 070155-56 | Warner-Lambert | Listerex Antibacterial Scrub |
| 070168 | Carter Products | Persol |
| 070172 | Chattem Labs | Mudd |
| 070173-5 | Dome (division of Miles) |
Acne-Dome Medicated Cleanser Acne-Dome Cream, Lotion |
| 070181 | Sterling Drug, Inc. | Stri-dex Medicated Pads |
| 070188 | Warner-Lambert | Listerex Herbal Scrub |
| 070191 | Pennwalt Corp. | Bare Face Acne Skin Medicine |
| 070199 | Norcliff Thayer | Oxy-10, Oxy-5 |
| 070206 | Barnes-Hind Pharmaceuticals | Komex Acne Scrub |
| 070207 | AHC Pharmacal | bp Gel Medication Strong, bp Gel Medication |
| 070218 | Barnes-Hind Pharmaceuticals | Komex Acne Scrub |
| 070230 | H.B. Distributing |
Hospital Brand Acne Cream |
| 070234-6 | Vick Divisions Research |
Clearasil Stick Clearasil Regular Tinted Clearasil Vanishing Cream |
| 070238 | Norcliff Thayer |
Oxy-5 Oxy-10 |
| 070239 | Purdue Frederick Co. | Betadine Skin Cleanser |
| 070242 | Sterling Drug, Inc. | Stri-dex |
| 070243 | Purdue Frederick Co. | Chemistry of povidone-iodine |
| 070244 | Bowman Pharmaceuticals, Inc. | Bowman Drawing Paste |
| 070245 | Press Chemical & Pharmaceuticals labs, Inc. | Wpsal Ointment |
| 070247 | Sterling Drug, Inc. | Campho-Phenique Liquid |
| 070248 | dome (division of Miles Lab, Inc.) | Vlem-Dome |
| 070249 | Sterling Drug, Inc. | Campho-Phenique Liquid |
| 070250 | Dome | Vlem-Dome |
| 070255 | Procter & Gamble | Tetracycline |
| 070256 | Avon Products, Inc. | Clear Skin Medicated Blemish Cream |
| 070259 | Stiefel Labs, Inc. | Sulfoxyl Lotion |
| 070260 | Sterling Drug, Inc. | Salicylic acid |
| 070261 | Stiefel Labs, Inc. | SAStid Soap |
| 070262 | The Proprietary Assn. | Benzoyl peroxide safety |
| 070263 | Herbert labs | Benzoyl peroxide |
| 070264 | Vick Divisions Research | Benzoyl peroxide |
| 070268 | Westwood Pharmaceuticals | Pernox |
| 070269 | Vick Divisions Research | Resorcinol |
| 070270 | Herbert Labs | Benzoyl peroxide |
| 070271 | Vick Divisions Research | Resorcinol |
| 070272 | Vick Divisions Research | Clearasil |
| 020273 | Westwood Pharmaceuticals | Laureth-4 (Polyoxyethylene-lauryl ether) |
| 070274 | Westwood Pharmaceuticals | Polyethylene Granules |
| 070275 | Warner-Lambert Co. | Thymol and polyethylene |
| 070276 | Press Chemical Co. | Epsal Ointment |
| 070277 | The Proprietary Assn. | Proposed Labeling |
| 070278 | Vick Divisions Research | Resorcinol |
| 070279 | Vick Divisions Research | Antibacterial activity and protocol for in vivo testing |
| 070280 | Vick Divisions Research | Prevention of new acne lesions |
| 070281 | Ketchum Labs. Inc. | Propa pH Super Cleaner |
| 070282 | Sterling Drug Inc. | Stri-dex |
| 070283 | Upjohn Co. | Plexion |
| 070284 | Vicks Divisions Research | Resorcinol |
| 070285 | Vick Divisions Research | In vitro protocol |
| 070286 | Sterling Drug Inc. | Salicylic Acid |
| 070287-8 | Koppers Co. | Resorcinol |
| 070289 | Stiefel Labs, Inc. | Benzoyl peroxide and sulfur |
| 070290 | Vick Divisions Research | Resorcinol |
| 070291 | Dermik Labs | Vlemasque |
| 070292 | Presentation and submissions to Panel November 14-15, 1980 | |
| 070293 | The Proprietary Assoc. | Benzoyl peroxide antimicrobial activity |
| 070294 | Information, Inc. | Benzoyl peroxide |
| 070295-296 | Acne References, Uncited | |
| 070297-300 | Acne References, Cited | |
| 07BPA1 | Panel’s Administrator’s File, Volume I - General | |
| 07BPA2A&B | Panel’s Administrator’s File, Volume II - Minutes of Panel meetings | |
| 07BPA3 | Panel Administrator’s File, Volume III - Correspondence File (1977 - 1979) | |
| 07BPA4 | Panel Administrator’s File, Volume IV - Correspondence File (1980 - 1981) |
TFM VOLUME 07BTFM
Has been established for Topical Acne
Drug Products
Topical Antifungal Drug Products for OTC Human Use
Establishment of a Monograph and Reopening of Administrative Record
Docket No. 80N-0476
Volume
07APA5
In the FEDERAL REGISTER of September 7, 1982 (47 FR 39464), the administrative record for the OTC topical antifungal drug products rulemaking was reopened to include a statement on OTC Drug Products for the Treatment of Diaper Rash by the Advisory Review Panel on OTC Miscellaneous External Drug Products. To avoid duplication, the Public Administrative File for that statement appears as part of the administrative file for the OTC external analgesic drug products rulemaking (Docket No. 78N-0301) that was also reopened on September 7, 1982 (47 FR 39412).
The material included in the topical anitfungal rulemaking is identified in OTC Volume 06BPA6 in the external analgesic administrative file.
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