ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops
Aru Pharma 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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QPACK ARTIFICIAL TEARS

Drug Facts

Active Ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye Lubricant

Uses

relieves dryness of the eye
prevents further irritation

Warnings

Do not use

if solution changes colour or becomes cloudy
with contact lenses

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.

Question or comments?

1-844-500-2729

between 9 am and 4 pm EST, Monday-Friday.

Directions

Instill 1 or 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

Compare to the active Ingredient in Liquifilm Tears Eye Drops

Lubricant Eye Drops

Prevents Irritation and Relieves Dryness of the eye

Distributed by.

ARU PARMA INC.

MOUNT VERNON, NY 10552

www.qpackrx.com

Packaging

Qpack1

ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70403-920
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70403-920-15	1 in 1 CARTON	03/31/2020	03/31/2025
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	03/31/2020	03/31/2025

Labeler - Aru Pharma Inc. (079736192)

Revised: 5/2023

Document Id: 6eb34145-5774-4fda-8120-6feb6c58bd47

Set id: 9339a60f-0bf2-4d3e-860f-ef8e9c6cea98

Version: 2

Effective Time: 20230515

Aru Pharma Inc.