Artificial Tears: Product Information

ARTIFICIAL TEARS- polyvinyl alcohol, unspecified solution/ drops
Patterson Veterinary

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.

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 Container Label
(click image for full-size original)

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.)

Principal Display Panel Text for Carton Label
(click image for full-size original)
ARTIFICIAL TEARS
polyvinyl alcohol, unspecified solution/ drops
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:14043-010
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyvinyl Alcohol, Unspecified (Polyvinyl Alcohol, Unspecified) Polyvinyl Alcohol, Unspecified 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzalkonium Chloride
Edetate Disodium
Sodium Chloride
Sodium Phosphate, Dibasic, Anhydrous
Sodium Phosphate, Monobasic, Anhydrous
Water
Sodium Hydroxide
Hydrochloric Acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:14043-010-15 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 15 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (14043-010-15)
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)
Registrant — Akorn Operating Company LLC (117693100)
Establishment
Name Address ID/FEI Operations
Akorn, Inc 117696840 MANUFACTURE, ANALYSIS, STERILIZE, PACK, LABEL
Establishment
Name Address ID/FEI Operations
Avantor Performance Materials International, Inc. 152791026 API MANUFACTURE

Revised: 10/2020 Patterson Veterinary

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2020. All Rights Reserved.