OPTASE- glycerin solution/ drops

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

0.25 % glycerin

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed get medical
help or contact a poison
control center right away.

PURPOSE

Eye Lubricant

INACTIVE INGREDIENT

Inactive ingredients:
Borax, Boric Acid, Citric Acid
anhydrous, Sodium Chloride,
Sodium Citrate Dihydrate,
Sodium Hyaluronate, water.

DOSAGE & ADMINISTRATION

Directions:
Put one or two drops in the
affected eyes as needed.

WARNINGS

Warning
For external use only.
If solution changes color or
becomes cloudy, do not use.

Stop use and ask doctor if
You feel eye pain.
Changes in vision occur.
Redness or irritation of the eye lasts.
Condition worsens or lasts
more than 72 hours

INDICATIONS & USAGE

Uses
For use as a lubricant to prevent
further irritation.
May be used as a protectant against
further irritation.
To relieve dryness of the eye.

Patient Information Leaflet- Page 1

Patient Information Leaflet- Page 2

PRINCIPAL DISPLAY PANEL

Immediate label

INGREDIENTS AND APPEARANCE

OPTASE 
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72972-005
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BORIC ACID (UNII: R57ZHV85D4)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72972-005-01	1 in 1 BOX	02/10/2023
1		10 mL in 1 BOTTLE, DISPENSING; 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	02/10/2023

Labeler - Scope Health Inc (116778693)

Registrant - Regulatory Matters Consulting (080711165)