Liquitears
FDA Label NDC 52959-041

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H.j. Harkins Company, Inc. for the product Liquitears (NDC 52959-041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

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

Keep Out Of Reach Of Children.

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

Directions

  • instill 1 to 2 drops in the affected eye(s) as needed

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%

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®.

Package/Label Principal Display Panel

Carton (D639b093 9907 4b20 A3a1 C19bfcedb5d7 01)

Carton (D639b093 9907 4b20 A3a1 C19bfcedb5d7 01)

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

* Please review the disclaimer below.