Artificial Tears Solution Drug Facts

Artificial Tears Solution Drug Facts
SPL v2
SPL
SPL Set ID d435c6fa-2442-4ff3-bfb9-c7f240e9226a
Route
OPHTHALMIC
Published
Effective Date 2012-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyvinyl Alcohol (14 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic Edetate Disodium Sodium Phosphate, Monobasic Sodium Chloride Water Benzalkonium Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-09

Description

Polyvinyl Alcohol 1.4%

Purpose

Lubricant


Medication Information

Purpose

Lubricant

Description

Polyvinyl Alcohol 1.4%

Uses
  • to prevent further irritation
  • to relieve dryness of the eye
Warnings
  • Do not use if solution changes color or becomes cloudy

When using this product  

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Directions
  • instill 1 to 2 drops in the affected eye(s) as needed
Questions ?

Serious side effects associated with use of this product may be reported to 1800-323-0000

*MAJOR LIQUITEARS IS NOT MANUFACTURED OR DISTRIBUTED BY ALLERGAN, INC. OWNER OF THE REGISTERED TRADEMARK, LIQUIFILM TEARS®.

Active Ingredient

Polyvinyl Alcohol 1.4%

Other Information
  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed

 

Inactive Ingredients

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, sodium chloride,

purified water. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Keep Out of Reach of Children

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

Package/label Principal Display Panel

MAJOR®

NDC 0904-5017-35

LiquiTears

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops (Sterile)

Relieves Burning due to Dryness of the Eye

Compare to Active Ingredient of Liquifilm Tears®*

1/2 FL. OZ. (15 mL)

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433


Structured Label Content

Uses
  • to prevent further irritation
  • to relieve dryness of the eye
Purpose

Lubricant

Warnings
  • Do not use if solution changes color or becomes cloudy

When using this product  

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Directions
  • instill 1 to 2 drops in the affected eye(s) as needed
Questions ?

Serious side effects associated with use of this product may be reported to 1800-323-0000

*MAJOR LIQUITEARS IS NOT MANUFACTURED OR DISTRIBUTED BY ALLERGAN, INC. OWNER OF THE REGISTERED TRADEMARK, LIQUIFILM TEARS®.

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)

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate, sodium chloride,

purified water. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

MAJOR®

NDC 0904-5017-35

LiquiTears

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops (Sterile)

Relieves Burning due to Dryness of the Eye

Compare to Active Ingredient of Liquifilm Tears®*

1/2 FL. OZ. (15 mL)

Repacked by:

H.J. Harkins Company, Inc.

Grover Beach, CA 93433


Advanced Ingredient Data


Raw Label Data

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