001-01

001-01
SPL v2
SPL
SPL Set ID 3eda8519-56be-cb15-e063-6394a90a8245
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
Poloxamer 188 Sodium Chloride Boric Acid Sodium Borate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-03

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

Directions

Shake well before using

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

Description

Hypromellose 0.2%

Section 50565-1

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

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

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, purified water.

Section 51945-4

Section 53413-1

Visit www.yd-biopharma.com

Section 55105-1

Lubricant

Section 55106-9

Hypromellose 0.2%

Section 59845-8

Shake well before using

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

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)

Directions

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)

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)

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)

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, purified water.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Visit www.yd-biopharma.com

Section 55105-1 (55105-1)

Lubricant

Section 55106-9 (55106-9)

Hypromellose 0.2%

Section 59845-8 (59845-8)

Shake well before using

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

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)