LIQUITEARS - polyvinyl alcohol solution/ drops 
H.J. Harkins Company, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Artificial Tears Solution Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

Warnings

When using this product  

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other information

 

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

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

LIQUITEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52959-041(NDC:0904-5017)
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52959-041-0015 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34912/09/2011
Labeler - H.J. Harkins Company, Inc. (147681894)
Registrant - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated807927397MANUFACTURE

Revised: 3/2012
Document Id: 7a471140-a07a-4ee7-926c-824f568ae061
Set id: d435c6fa-2442-4ff3-bfb9-c7f240e9226a
Version: 2
Effective Time: 20120309
 
H.J. Harkins Company, Inc.