ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

Artificial Tears by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 if 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 doctor if

condition persists or increases discontinue use and consult a veterinarian.

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-free 1-800-932-5676

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC: 59399-160-15

15 mL

ARTIFICIAL

TEARS

SOLUTION

Polyvinyl Alcohol 1.4%

Lubricant Eye Drops

For Veterinary Use

Sterile

15 mL (0.5 fl. oz.)

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC: 59399-160-15

Akorn Animal Health Logo

15 mL

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 solution/ drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 59399-160
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyvinyl Alcohol (UNII: 532B59J990) (Polyvinyl Alcohol - UNII:532B59J990)	Polyvinyl Alcohol	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: 59399-160-15	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		06/15/2015

Labeler - Akorn Animal Health, Inc. (078876357)

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