ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

ARTIFICIAL TEARS by

Drug Labeling and Warnings

ARTIFICIAL TEARS by is a Otc medication manufactured, distributed, or labeled by Aru Pharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

QUESTIONS

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - Aru Pharma Inc. (079736192)