SPL v3
SPL
SPL Set ID e9b0ed39-60c8-1093-e053-2a95a90a705b
Route
OPHTHALMIC
Published
Effective Date 2024-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol, Unspecified (1.4 mg)
Inactive Ingredients
Benzalkonium Chloride Sodium Chloride Edetate Disodium Sodium Phosphate, Monobasic, Dihydrate Sodium Phosphate, Dibasic, Dodecahydrate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-31

Description

​Polyvinyl alcohol 1.4%

Purpose

Lubricant


Medication Information

Purpose

Lubricant

Description

​Polyvinyl alcohol 1.4%

Uses

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

Warnings

For external use only

Directions

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

Active Ingredient

​Polyvinyl alcohol 1.4%

Other Information

Store at 15°-30°C (59°-86°F).

Keep tightly closed.

Inactive Ingredients

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection

Do Not Use This Product

If you are allergic to polyvinyl alcohol or any of the other listed ingredients.

If solution changes color or becomes cloudy.

While wearing contact lenses.

When Using This Product

Do not touch tip of container to your eye or to any surface to avoid contamination.

Replace cap after each use.

Stop Use and Ask A Doctor If

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Ulai Health Vis Guard Polyvinyl Alcohol 1.4% Lubricant Eye Drops 15ml


Structured Label Content

Uses

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

Purpose

Lubricant

Warnings

For external use only

Directions

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

Active Ingredient (Active ingredient)

​Polyvinyl alcohol 1.4%

Other Information (Other information)

Store at 15°-30°C (59°-86°F).

Keep tightly closed.

Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection

Do Not Use This Product (Do not use this product)

If you are allergic to polyvinyl alcohol or any of the other listed ingredients.

If solution changes color or becomes cloudy.

While wearing contact lenses.

When Using This Product (When using this product)

Do not touch tip of container to your eye or to any surface to avoid contamination.

Replace cap after each use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

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 (1-800-222-1222).

Ulai Health Vis Guard Polyvinyl Alcohol 1.4% Lubricant Eye Drops 15ml (ULAI HEALTH Vis Guard POLYVINYL ALCOHOL 1.4% LUBRICANT EYE DROPS 15ML)


Advanced Ingredient Data


Raw Label Data

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