Optase Dry Eye Intense Drops

Optase Dry Eye Intense Drops
SPL v9
SPL
SPL Set ID 9e96976b-2990-79e0-e053-2995a90a0f29
Route
OPHTHALMIC
Published
Effective Date 2026-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2 mg)
Inactive Ingredients
Hyaluronate Sodium Hydrochloric Acid Water Tromethamine Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-02-14

Description

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


Medication Information

Warnings and Precautions

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 and Usage

Uses

• To relieve dryness of the eye.

• For use as a lubricant or protectant to prevent

further irritation.

Dosage and Administration

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.

Description

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

Section 50565-1

Keep out of reach and sight of children.

If swallowed get medical help or contact a

Poison Control Center right away.

Section 51727-6

Inactive ingredients

Hydrochloric acid, Sodium hyaluronate, Sorbitol,

Tromethamine, Water.

Section 55105-1

Eye Lubricant

Section 55106-9

Glycerin 0.2 %

Immediate Label

Optase Intense Mdu

Insert/instructions

Insert/instructions Page 2


Structured Label Content

Indications and Usage (34067-9)

Uses

• To relieve dryness of the eye.

• For use as a lubricant or protectant to prevent

further irritation.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach and sight of children.

If swallowed get medical help or contact a

Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

Hydrochloric acid, Sodium hyaluronate, Sorbitol,

Tromethamine, Water.

Section 55105-1 (55105-1)

Eye Lubricant

Section 55106-9 (55106-9)

Glycerin 0.2 %

Immediate Label (Immediate label)

Optase Intense Mdu (Optase Intense MDU)

Insert/instructions (Insert/Instructions)

Insert/instructions Page 2 (Insert/Instructions - Page 2)


Advanced Ingredient Data


Raw Label Data

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