002-01

002-01
SPL v1
SPL
SPL Set ID 3edf547d-da0d-7e0d-e063-6394a90a5702
Route
OPHTHALMIC
Published
Effective Date 2025-09-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hypromelloses (0.2 g)
Inactive Ingredients
Sodium Chloride Sodium Borate Boric Acid Water Poloxamer 188

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-17

Description

Hypromellose 0.2%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of burning and irritation due to dryness of the eye

For use as a protectant against further irritation

Dosage and Administration

Shake well before using

Instill 1-2 drops in the affected eye(s) as needed

Description

Hypromellose 0.2%

Section 50565-1

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if you experience any of the following:

Eye pain

Changes in vision

Continued redness or irritation of the eye

Condition worsens or persists for more than 72 hours

Section 50567-7

When using this product

Do not touch tip of container to any surface to avoid contamination

Replace cap after each use

Do not use if bottle seal is broken or missing

Section 50569-3

Stop use and ask a doctor if you experience any of the following:

Eye pain

Changes in vision

Continued redness or irritation of the eye

Condition worsens or persists for more than 72 hours

Section 50570-1

Do not use

If this solution changes color or becomes cloudy

If you are sensitive to any ingredient in this product

Section 51727-6

Sodium chloride, poloxamer, boric acid, sodium borate decahydrate, water for injection.

Section 51945-4

Section 53413-1

visit www.exovissecare.com

Section 55105-1

Lubricant.

Section 55106-9

Hypromellose 0.2%

Section 60561-8

Store at room temperature

Use before expiration date marked on container

Retain this carton for future reference


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of burning and irritation due to dryness of the eye

For use as a protectant against further irritation

Dosage and Administration (34068-7)

Shake well before using

Instill 1-2 drops in the affected eye(s) as needed

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

Eye pain

Changes in vision

Continued redness or irritation of the eye

Condition worsens or persists for more than 72 hours

Section 50567-7 (50567-7)

When using this product

Do not touch tip of container to any surface to avoid contamination

Replace cap after each use

Do not use if bottle seal is broken or missing

Section 50569-3 (50569-3)

Stop use and ask a doctor if you experience any of the following:

Eye pain

Changes in vision

Continued redness or irritation of the eye

Condition worsens or persists for more than 72 hours

Section 50570-1 (50570-1)

Do not use

If this solution changes color or becomes cloudy

If you are sensitive to any ingredient in this product

Section 51727-6 (51727-6)

Sodium chloride, poloxamer, boric acid, sodium borate decahydrate, water for injection.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

visit www.exovissecare.com

Section 55105-1 (55105-1)

Lubricant.

Section 55106-9 (55106-9)

Hypromellose 0.2%

Section 60561-8 (60561-8)

Store at room temperature

Use before expiration date marked on container

Retain this carton for future reference


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)