Optase Dry Eye Intense Drops

Manufacturer
Scope Health Inc | Regulatory Matters Consulting
Effective date
2026-01-30
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:35:58

Label at a glance#

ProductOptase
Active ingredientGLYCERIN
Label structure9 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive ingredients
Hydrochloric acid, Sodium hyaluronate, Sorbitol,
Tromethamine, Water.

WARNINGS SECTION

Warnings
• For external use only.
• Once opened, use within 3 months and within the
stated expiry date.
• Discard any unused product after 3 months.
• To avoid contamination do not touch, wipe or clean
the tip of the nozzle. Replace cap tightly after using.
Do not use
• If this product changes color or becomes cloudy.
• If the bottle or the tamper evident seal is damaged.
• If you puncture, pierce or otherwise tamper with the
applicator tip or bottle.
• If you are sensitive to any ingredient in this product.
When using this product
• To avoid contamination do not touch, wipe or clean
the tip of the nozzle.
• Do not squeeze the bottle when removing and
replacing the cap.
Stop use and ask doctor if
• You feel eye pain, changes in vision occur, continued
redness or irritation of the eye occurs.
• Conditions worsen or persist for more than 72 hours.
Keep out of reach and sight of children.
If swallowed get medical help or contact a
Poison Control Center right away.

INDICATIONS & USAGE SECTION

Uses
• To relieve dryness of the eye.
• For use as a lubricant or protectant to prevent
further irritation.

DOSAGE & ADMINISTRATION SECTION

Directions
• Shake well before use.
• Before first use, remove the cap, hold the bottle
upside down and discard one drop of product.
• To deliver the drop, gently squeeze and release
the bottle once.
• Put one or two drops in the affected eye(s) as needed.
• After use, flick/shake the bottle (vigorously)
downwards, ensuring no residual drop is left.
Multiple flicks/shakes may be required before
replacing the cap. See diagram 1 below.
• Do not deliver more than 25 drops per 24h period,
and do not deliver more than 25 drops consecutively.
• For additional information, please refer to leaflet.

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2 %

OTC - PURPOSE SECTION

Eye Lubricant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach and sight of children.
If swallowed get medical help or contact a
Poison Control Center right away.

Insert/Instructions

OTHER SAFETY INFORMATION

Optase Intense MDU PIL page 1Optase Intense MDU PIL page 1

Insert/Instructions - Page 2

OTHER SAFETY INFORMATION

Optase Intense MDU PIL page 2Optase Intense MDU PIL page 2

Optase Intense MDU

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optase Intense MDUOptase Intense MDU

Immediate label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Optase Intense MDU bottle labelOptase Intense MDU bottle label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998232glycerin 0.2 % Ophthalmic SolutionPSN9
998232glycerin 2 MG/ML Ophthalmic SolutionSCD9
998232glycerin 0.2 % Ophthalmic SolutionSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 39 Extended65NOT8480!OPTASE US Intense PIL October 2025 OUTLINED (P)_Page_1.jpg
Data codeData Matrix66ETU8480/AOPTASE Intense MDU Carton.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72972-002-01Optase1 in 1 BOXSOLUTION/ DROPS19
72972-002-01Optase9.75 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS9.759

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72972-00272972-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
ndc (package): 72972-002-01
ndc (product): 72972-002
ndc11 (package): 72972000201
spl id: 49a44c61-bccb-ab89-e063-6394a90aa2b1
spl set id: 9e96976b-2990-79e0-e053-2995a90a0f29

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.