Regulatory Information
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 Dome Labs |
Comments on sunscreen draft “ ” |
| 060182 | References, Cited | |
| 060183 | References, Uncited | |
| 060185 | References, Cited--Measurements
|
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 |
