Animal NDC 59399-160-15 Artificial Tears

Polyvinyl Alcohol

Animal NDC Product Code 59399-160-15

Field Name Field Value
Animal NDC Code 59399-160-15
Proprietary Name Artificial Tears What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Polyvinyl Alcohol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Akorn Animal Health, Inc.
Product Type Otc Animal Drug
Active Ingredient(s)
  • Polyvinyl Alcohol
Inactive Ingredient(s)
  • BENZALKONIUM CHLORIDE (F5UM2KM3W7)
  • EDETATE DISODIUM (7FLD91C86K)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (KH7I04HPUU)
  • WATER (059QF0KO0R)
  • SODIUM HYDROXIDE (55X04QC32I)
  • HYDROCHLORIC ACID (QTT17582CB)
  • BENZALKONIUM CHLORIDE (F5UM2KM3W7)
  • EDETATE DISODIUM (7FLD91C86K)
  • SODIUM CHLORIDE (451W47IQ8X)
  • SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (22ADO53M6F)
  • SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (KH7I04HPUU)
  • WATER (059QF0KO0R)
  • SODIUM HYDROXIDE (55X04QC32I)
  • HYDROCHLORIC ACID (QTT17582CB)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Artificial Tears Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

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, Purified Water USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

Call toll-free 1-800-932-5676

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.

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