OPTASE- glycerin solution/ drops

Optase by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Glycerin 0.2%

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

WARNINGS

Warning
For external use only.
To avoid contamination, do not touch tip of container to any surface.
If solution changes color or becomes cloudy, do not use.
Do not use a damaged or punctured single-dose container.
Wait at least 15 minutes between possible applications of other ophthalmic medication.

Use immediately once opened.
Do not reuse. Discard any remaining solution after use.
Do not use if you are sensitive to any of the ingredients.
Do not use after the expiry date shown on the pack.

INDICATIONS & USAGE

For use as a lubricant to

prevent further irritation.

May be used as a protectant

against further irritation.

To relieve dryness of the eye.

DOSAGE & ADMINISTRATION

Please wash your hands before use. Open the aluminium pouch and pull out the strip of single-dose containers. Remove one of the single-dose containers from the strip. Place the remaining single-dose containers back and close the pouch by folding the edge over. To open, twist and pull tab to remove. Do not touch the tip after opening the container. Put one or two drops in the affected eyes as needed Use immediately once opened. Do not reuse. Discard any remaining solution after use.
No ingredients of animal origin. Contact lens compatible.

INACTIVE INGREDIENT

Inactive ingredients
Hydrochloric Acid, Sodium Hyaluronate, Sorbitol, Trometamol, Water

PRINCIPAL DISPLAY PANEL

Patient Information Leaflet- 30 count

Patient Information Leaflet- IFU

PRINCIPAL DISPLAY PANEL

Patient Information Leaflet- 5 count

Patient Leaflet - IFU - 5 count

Single Dose Aluminum Foil Label- 5 pack

INGREDIENTS AND APPEARANCE

OPTASE 
glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72972-007
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)
TROMETHAMINE (UNII: 023C2WHX2V)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72972-007-30	1 in 1 BOX	02/07/2024
1		30 in 1 DOSE PACK
1		0.5 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 72972-007-05	1 in 1 BOX	02/07/2024
2		5 in 1 DOSE PACK
2		0.5 mL in 1 BOTTLE, UNIT-DOSE; 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	02/07/2024

Labeler - Scope Health Inc (116778693)

Registrant - Scope Health Inc (116778693)