Optase by Scope Health Inc / Regulatory Matters Consulting OPTASE- glycerin spray

Optase by

Drug Labeling and Warnings

Optase by is a Otc medication manufactured, distributed, or labeled by Scope Health Inc, Regulatory Matters Consulting. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

KEEP OUT OF REACH OF CHILDREN

PURPOSE

WARNINGS

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TROMETHAMINE (UNII: 023C2WHX2V)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

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 final	part349	04/22/2019

Labeler - Scope Health Inc (116778693)

Registrant - Regulatory Matters Consulting (080711165)