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OTC - Panel Submissions (Indices Only): 07 - Antimicrobial II

Docket No.  80N-0476

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  Preston Pharmaceutics 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  Preston Pharmaceutics 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  Co. 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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