ARTIFICIAL TEARS- polyvinyl alcohol, unspecified solution/ drops

Artificial Tears by

Drug Labeling and Warnings

Artificial Tears by is a Animal medication manufactured, distributed, or labeled by Patterson Veterinary, Akorn Operating Company LLC, Akorn, Avantor Performance Materials International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye Lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

• Do not use if imprinted seal on the bottle neck is broken or missing.
• Do not use it solution changes color or becomes cloudy.
• To avoid contamination, do not touch tip of container to any surface.
• Replace cap after using.

Stop use and ask a veterinarian if your pet experiences eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep out of the reach of children.

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

Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

• Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• Store away from heat.
• Protect from freezing.
• Keep tightly closed.
• RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Water for Injection, USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

call toll-tree 1-800-225-7911

Principal Display Panel Text for Container Label:

NDC: 14043-010-15

ARTIFICIAL

TEARS

SOLUTION

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

For Veterinary Use

Sterile

15 mL (0.5 fl. oz.)

Principal Display Panel Text for Carton Label:

PATTERSON

VETERINARY

1-800-225-7911

NDC: 14043-010-15

ARTIFICIAL

TEARS

SOLUTION

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

For Veterinary Use

Prevents Irritation and

Relieves Dryness

of the Eye

Sterile

15 mL (0.5 fl. oz.)

INGREDIENTS AND APPEARANCE

ARTIFICIAL TEARS 
polyvinyl alcohol, unspecified solution/ drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 14043-010
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)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Sodium Phosphate, Monobasic, Anhydrous (UNII: KH7I04HPUU)
Water (UNII: 059QF0KO0R)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydrochloric Acid (UNII: QTT17582CB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14043-010-15	1 in 1 CARTON
1		15 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/20/2013

Labeler - Patterson Veterinary (006962500)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn, Inc		603980319	MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL

Establishment
Name	Address	ID/FEI	Business Operations
Avantor Performance Materials International, Inc.		152791026	API MANUFACTURE