MAJOR LIQUITEARS- polyvinyl alcohol solution/ drops 
Major Pharmaceuticals

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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Active ingredient                                                Purpose

Polyvinyl Alcohol 1.4%..................................... 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 each 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°-25°C (59°-77°F)
•
keep tightly closed

Inactive ingredients

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

Distributed by:

Major Pharmaceuticals

31778 Enterprise Drive

Livonia, MI 48150 USA


Made in Korea

image description
MAJOR LIQUITEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6492
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6492-351 in 1 CARTON09/17/201511/30/2020
115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/17/201511/30/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2020
Document Id: d13dfad3-6c90-4a13-9e04-41d301c179e3
Set id: b5708848-41fc-4ae2-958a-41c0d29c8e6f
Version: 2
Effective Time: 20200103
 
Major Pharmaceuticals