LIQUITEARS- polyvinyl alcohol solution/ drops

LiquiTears by

Drug Labeling and Warnings

LiquiTears by is a Otc medication manufactured, distributed, or labeled by H.J. Harkins Company, Inc., Bausch & Lomb Incorporated. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

INGREDIENTS AND APPEARANCE

LIQUITEARS 
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52959-041(NDC: 0904-5017)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	14 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52959-041-00	15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	12/09/2011

Labeler - H.J. Harkins Company, Inc. (147681894)

Registrant - Bausch & Lomb Incorporated (196603781)

Establishment
Name	Address	ID/FEI	Business Operations
Bausch & Lomb Incorporated		807927397	MANUFACTURE