ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops 
Akorn

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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

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

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 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 Text for Container Label

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.)

Principal Display Panel Text for Carton Label
ARTIFICIAL TEARS 
polyvinyl alcohol solution/ drops
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59399-160
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyvinyl Alcohol, Unspecified (UNII: 532B59J990) (Polyvinyl Alcohol, Unspecified - UNII:532B59J990) Polyvinyl Alcohol, Unspecified14 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59399-160-151 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/15/2015
Labeler - Akorn (117693100)
Establishment
NameAddressID/FEIBusiness Operations
Akorn117696840MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
Establishment
NameAddressID/FEIBusiness Operations
Avantor Performance Materials International, Inc.152791026API MANUFACTURE

Revised: 11/2022
Document Id: 914d96ee-19f1-4cc4-b1f6-f07d28f7a963
Set id: 2ef16864-97cb-4dfe-9461-cba156144c69
Version: 5
Effective Time: 20221103
 
Akorn