Major LiquiTears: Package Insert and Label Information

MAJOR LIQUITEARS- polyvinyl alcohol, unspecified solution/ drops
Proficient Rx LP

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.

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

Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320


Made in Korea

71205-139-1571205-139-15
MAJOR LIQUITEARS
polyvinyl alcohol solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-139(NDC:0904-6492)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL, UNSPECIFIED) POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE
EDETATE DISODIUM
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE
WATER
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71205-139-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (71205-139-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 09/17/2015
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 RELABEL (71205-139)

Revised: 10/2019 Proficient Rx LP

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