OPTASE- glycerin spray
Scope Health Inc
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Optase Dry Eye Spray 17 ml (part of 3 step process)
OPTASE
glycerin spray
Product Information
Product Type
HUMAN OTC DRUG
Item Code (Source)
NDC:72972-001
Route of Administration
OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
GLYCERIN
(UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)
GLYCERIN
1 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
HIPPOPHAE RHAMNOIDES SEED OIL
(UNII: T53SBG6741)
SODIUM CHLORIDE
(UNII: 451W47IQ8X)
WATER
(UNII: 059QF0KO0R)
HYALURONATE SODIUM
(UNII: YSE9PPT4TH)
POLYSORBATE 80
(UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE
(UNII: 06XEA2VD56)
TROMETHAMINE
(UNII: 023C2WHX2V)
POTASSIUM CHLORIDE
(UNII: 660YQ98I10)
CITRIC ACID MONOHYDRATE
(UNII: 2968PHW8QP)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:72972-001-01
1 in 1 BOX
04/22/2019
1
17 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC Monograph Drug
M018
04/22/2019
Labeler -
Scope Health Inc (116778693)
Registrant -
Regulatory Matters Consulting (080711165)
Revised: 11/2023
Document Id:
0a7b9f23-0baa-a4bc-e063-6294a90a1657
34390-5
Set id: 86c14327-ffc7-806e-e053-2991aa0aaf92
Version: 6
Effective Time: 20231119
Scope Health Inc