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OTC Panel Submission (Indices Only): 10 - Ophthalmic

Ophthalmic Administrative File

OTC Ophthalmic Drug Products

(Docket No. 80N-0145)

100001 Flow Pharmaceuticals, Inc. Hy-Flow, aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol
100002 Riker Laboratories, Inc. Bro-Lac, Op-Isophrin, Wet-Tone
100003 Julius Schmid, Inc. Eyegenic Eye Mist



Julius Schmid, Inc. Eye-Gene Eye Drops
100006 Abbott Laboratories Murine
100007 Burton, Parsons & Company, Inc. Adsorbonac 2%
100008 Burton , parsons & Company, Inc. Adsorbonac 5%
100009 Burton , parsons & Company, Inc. Soothe



Norwich Pharmacal Company

Ocusol Eye Lotion,

Ocusol eye Drops

100013 Wyeth Laboratories, Inc. Collyrium Soothing eye Lotion, Collyrium with Ephedrine Soothing Eye Drops
100014 Professional Pharmacal Company Bufopto Zinc Sulfate
100015 Professional Pharmacal Company Efricel 1/8%
100016 Professional Pharmacal Company Neozin
100017 Professional Pharmacal Company Methulose, Visculose
100018 Barnes-Hind Pharmaceuticals, Inc. Degest
100019 Pfizer Pharmaceuticals Visine Eye Drops
100020 Alcon Laboratories, Inc. Contique Contact Lens Wetting Solution, Lens-Mate
100021 Alcon Laboratories, Inc. Isopto Frin
100022 Alcon Laboratories, Inc. Naphcon
100023 Alcon Laboratories, Inc. Op-Thal-Zin
100027 Alcon Laboratories, Inc. Contique Artificial Tears
100030 Alcon Laboratories, Inc. Zincfrin
100031 Alcon Laboratories, Inc. Estivin
100032 Alcon Laboratories, Inc. Isopto Tears, Ultra Tears
100033 Alcon Laboratories, Inc. Eye-Stream

LaWall & Harrisson

Research laboratories, Inc.

20/20 Eye Drops



Abbott Laboratories Clear Eyes




Cooper Laboratories, Inc.

Argyrol S.S.,

Goniosol, M-Z,

Phenylzin, Tear-Efrin,


100040 Allergan Pharmaceuticals Lacril
100041 Allergan Pharmaceuticals Lacri-Lube S.O.P.
100043 Commerce Drug Company, Inc. Ocu-Drop
100044 Commerce Drug Company, Inc. Stye
100045 Commerce Drug Company, Inc. Ocu-Bath
100046  Alcon Laboratories, Inc.


Artifical Tears

Additional Data

100047 Allergan Pharmaceuticals Pre-Sert
100048 Abbott Laboratories


Additional Data

100050 Alcon Laboratories, Inc. Contique Dual-Wet Solution
100051 Alcon Laboratories, Inc. Lens-Mate
100052 Alcon Laboratories, Inc. Tears naturale’



Mitchum-Thayer, Inc. Mitchum’s Eye Drops
100055 Proprietary Association Test Method Used for All Purpose Contact Lens Solutions
100056 Allergan Pharmaceuticals Total
100057 Schering Corporation

Documentation in Support of Methylparaben and Propylparaben Comination

Documentation in Support of Sodium Thiosulfate

Documentation in Support of Tyloxapol

100058 Alcon Laboratories, Inc. General Guidelines Applicable to the Evaluation of Lens Care Products
100059 Allergan Pharmaceuticals Blink-N-Clean
100060 Allergan Pharmaceuticals Liquifilm
100061 Allergan Pharmaceuticals Liquifilm Tears
100062 Allergan Pharmaceuticals Prefrin Liquifilm Eye Drops
100063 Allergan Pharmaceuticals Prefrin-Z Liquifilm
100066 Allergan Pharmaceuticals Comments and Recommendations on Panel’s Summary Minutes
100067 Alcon Laboratories, Inc. Comments and Recommendations on Panels’s Summary Minutes
100068 Alcon Laboratories, Inc. Additional Comments on Cleaning and Wetting Agents




Flow Pharmaceuticals

hy-Flow, aqua-Flow, Comfy, duo-Flow, d-Film, Trilisol

Additional data

100072 Schering Corporation Comment on 10% Sulfacetamide and 2.3% Sodium Chloride Solution
100073 Alcon Laboratories, Inc. Supplemental Data on Cleaning and Wetting Agents
100074 Alcon Laboratories, Inc. Additional Studies Regarding Benzalkonium Chloride
100075 Allergan Pharmaceuticals Comments on Warnings and Labeling
100076 Allergan Pharmaceuticals Additional Information on “Preservative information”
100078 Norcliff Thayer, Inc. Safety Protocol for 0.05% Naphazoline
100079 K.C. Tsou, Ph.D.   University of  Pennsylvania Cytochemical Methods
100080 Allergan Pharmaceuticals Data on  “Draize” Testing Ethylene Oxide Testing, and Buffering
100081 Alcon Laboratories, Inc.


Additional Data


Woody D. Davis, M.D.

  Meridian ,  Mississippi 

Letter to Panel on Stye Ointment
100083 Norwich Pharmacal Co. Supplemental Information on Ocusol Eye Lotion and Comment on Eye  Wash and Eye Lotion
100084 Flow Pharmaceuticals Clerz
100085 Alcon Laboratories, Inc. Supplemental Information on Hydroxypropylmethyl-cellulose
100086 U.S.V. Pharmaceutical Corp. Supplemental Information on 0.05% Naphazoline
100087 Allergan Pharmaceuticals Methodology for testing Safety, Effectiveness of Hard Contact Lenses.  Data for Polyethylene glycol, Polyoxylstearate, Polysorbate.  Volumes 1 and 2
100088 Alcon Laboratories, Inc. Benzalkonium Chloride as a Preservative






Schering Corporation Sulffacetamide Data
100094 U.S.V. Pharmaceutical Corp. Naphazoline Data: Dr.  S. Morgan, Galin, U.S.V. Letter October 21, 1975
100095 Allergan Pharmaceuticals Polyvinyl Alcohol Data on Effectiveness as Wetting Agent
100096 Ketchum Laboratories Comments on Preservative Test Guidelines
100097 Calvin Hanna Data on 0.05% Naphazoline
100098 Allergan Pharmaceuticals Data on the use of Sodium Citrate in Lacril and Liquidifilm Forte
100099 Alcon Laboratories, Inc.


Additional Data

100100 Alcon Laboratories, Inc. Collaborative Industry Study on the Effect of Serum on the Preservative Effectiveness of Hard Contact Lens Solutions

Woody D. Davis, M.D.

  Meridian ,  Mississippi 

Transcript of Presentation to Panel on Stye Ointment
101102 Proprietary Association Statement on FDA Policy on Exclususivity of Labeling Terms
100103 Cooper Laboratories, Inc. Recommendation to the Panel to Allow Flexibility to Adjust Osmolarity for Ophthalmic Products and Expansion of the List of Acceptable Polyethylene Glycols
100104 Sherman Laboratories, Inc. Aqueo-Rinse, Dual-Clean Pena-Vel, Stay-Brite, Stay-Wet, Velva-Kleer
100105 Commerce Drug Company, Inc. Study on the Safety and Efficacy of Mercuric Oxide Ointment for Relief of Sties and Minor Infections of the Eyelids
100106 Proprietary Association Comments and Recommendations on Panel’s Report
100107 Medical Library OTC Drug Literature Program - Ophthalmic Preparations
100108 Cooper Laboratories, Inc. Additional Information on Mild Silver Protein as an Anti-infective
100109 Cooper Laboratories, Inc. Comments on Panel’s Summary Minutes
100110 Cooper Laboratories, Inc. Polyethylene Glycol Additional Information
100111 William H. Havener, M.D. Comments on Madatory OTC Drug Labeling

Public Administrative File

OTC Ophthalmic Drug Products

(Docket No. 80N-0145)

Alphabetical Listing of

References Cited in Report

100112 A - B
100113 C - D
100114 E - G
100115 H - J
100116 K - M
100117 N - R
100118 O: “Ophthalmology Prescription Handbook” (only)
100119 S
100120 T - Z
100121 Miscellaneous Uncited References:   A - E
100122 Miscellaneous Uncited References:   F - H
100123 Miscellaneous Uncited References:   I - R
100124 Uncited References:   S:   Smith, R.B. editor, “Anesthesia in Ophthalmology” (only)
100125 Miscellaneous Uncited References:   S - Z

Administrative File

OTC Ophthalmic Drug Products

Docket No. 80N-0145

Panel Administrator’s File


Panel Administrator’s File,

Volume I - General

1.1    Call for Data

1.2    List of Panel Members and Liaisons

1.3    Curriculum Vitae of Panel Members and Liaisons

1.4    General and Specific Charge to Panel

1.5    Index to Panel Submissions

1.6    Regulatory Analysis Assessment


Panel Administrator’s File,

Volume II - Minutes of Panel Meetings.


Panel Administrator’s File,

Volume III - Correspondence File,