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OTC Panel Submissions (Indices Only): 06 - Topical Analgesic (Part 1)

PUBLIC ADMINISTRATIVE FILE
Sunscreen Volumes

VOLUME COMPANY SUBJECT
060001 Texas  Pharmacal A-Fil Cream
060002             “ Sundare Creamy Lotion
060003             “ Sundare Clear Lotion
060004             “ Sun Stick Lip Protectant
060005 Felton Chemical Co. Suncreme Concentrate WMO
060010 Van Dyck & Co., Inc. Escalol 507
060018               “ Escalol 508
060019               “ Escalol 106
060021 Givaudan Corporation Giv-Tan F
060037 Menley & James Labs Sea and Skin Golden Tan
060044 Texas  Phar. Sun Swept Cream
060057 Westwood Pharm., Inc. PreSun Lotion

060064 

060065 

060066 

060067

Plough, Inc. 

    “

    ”

    “

Coppertone, etc.

    “ 

Sudden Tan QT 

Foam

060069 Rowell Labs, Inc. Doushield Two, One

060070 

060072

Plough, Inc.

        “

Sunshielding Lotion

Sun Protective Foam

060076 Lanvin - Charles of the Ritz Ravenescence, etc.
060081 Westwood Pham. Presun, additional
060083 greiter Corp. Int. Piz Buin, etc.
060084 Amerchol Amerscreen P
060086 E. M. Labs Eusolex, etc.
060088 Felton Chem. Co. Sunarome Conc.
060089 Haarman & Reimer Corp. Neo Heliopan AV
060090 E. M. Labs Eusolex - additional data
060091 Bonne Bell Inc. Triethanolamine salicylate
060093 E. M. Labs Eusolex 3573 - additional data

060103 

060104

G. S. Herbert Labs

              “

Eclipse
060105 Amerchol Amerscreen P
060110 Givaudan Corp. Parsol MX, Parsol Hydro
060115 E. M. Labs Eusolex 6300
060116 Miles Labs Sunguard
060117 Chattem Labs Alpaba
060120 Elizabeth Arden Inc. Sun Gelee
060125 Texas Pharmacal Co. A-Fil - additional data
060128 GAF Corp. Technical information
060129 Hill Top Research Sunscreens
060130 Greiter Corp. Additional data
060131 Plough, Inc. Additional data
060134 Scher Chemical Dipsal
060135 Plough, Inc. Sun Protective Lotion
060143 Greiter Corp. UV Filters
060145 Van Dyck Additional data
060147 Schuylkill Chem. Co. Alpaba - additional data
060148 Westwood Pharm. Presun - additional data
060151 Felton Int. Sunarome
060154 Paul B. Elder RVP with Magnasurf
060155 PA/CTFA comment on sunscreens  
060157 Greiter Additional data
060158 Hill Top Comments
060159 Johnson & Johnson Testing
060162 Givaudan Parsol MCX
060163 Elizabeth Arden Suncare Line
060164 Plough, Inc. Testing
060165 AVA, Inc. Aloe Vera Gel for Sun, Vehicles

060166 

060167

Westwood

         “

Label  comments Protocol for tests
060168 Johnson & Johnson  
060169 CTFA/PA Comparative tests
060170 Plough Skin cancer data
060171 Ingram Pharm. Co. UV absorber 3

060175 

060176 060177

Westwood
Johnson & Johnson 

Dome Labs

Comments on sunscreen draft                        

“                        

060182 References, Cited  
060183 References, Uncited  
060185 References, Cited--Measurements
  • f UV Radiation in the  US  and Comparisons with Skin Cancer Data
 

Panel Administrator’s File (Correspondence File), Volume I 

Panel Administrator’s File (Correspondence File), Volume II 

Minutes of the OTC Panel on Topical Analgesic, Antirheumatic, Otic, Burn, and Sunburn Treatment and Prevention Drug Products

Skin Protectants

VOLUME COMPANY SUBJECT
060007-A E. R. Squibb Zinc Oxide Ointment
060011 Gebauer Chem. Co. Gebauer’s Tannic Spray
060034 Church & Dwight Co., Inc. Sodium bicarbonate
060065 (see sunscreen vols) Plough, Inc. Coppertone Lip Balm
060080-B Calhoun’s Lab. Burn-O-Jel
060109 Chesebrough-Pond’s Inc. Vaseline
060112 Whitehall Labs., Inc.
Sperti Healing Ointment
060113 Whitehall Labs., Inc.
Digene Chafing Ointment
060114 Whitehall Labs., Inc.
Digene Chafling Ointment
060123-A Bowman Pharm., Inc. Almophen Ointment Calamine Compound Easte Caloxol Lotion Petrozine Ointment
060137 Plough, Inc. Mexsana Medicated Powder
060149 American Home Products Co. Additional SRF data
060152 Otis Clapp & Sons Obtundia Calamine Cream
060160 American Home Products Co. Additional SRF data
060172 Plough, Inc. Dimethicone

ADMINISTRATIVE FILE

Skin Protectant Drug Products for OTC Human Use

Establishment of a Monograph and Reopening of Administrative Record

Docket No.  78N-0021

Volume

06DPA2

In the FEDERAL REGISTER of September 7, 1982 (47 FR 39436), the administrative record for the OTC skin protectant drug products rulemaking was reopened to include 5 statements by the Advisory Review Panel on OTC Miscellaneous External Drug Products.  To avoid duplication, the Public 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 name of each statement included in the skin protectant rulemaking and its corresponding volume number in the external analgesic administrative file appears below.

Statemnet Volume No.
OTC Drug Products for the Treatment of Diaper Rash 06BPA6
OTC Drug Products for the Prevention of Poison Ivy, Oak, and Sumac 06BPA7
OTC Drug Products for the Treatment of Fever Blisters 06BPA8
OTC Astringent Drug Products 06BPA10
OTC Insect Bite Neutralizer Drug Products 06BPA11

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