Artificial Tears

Manufacturer
A-S Medication Solutions
Effective date
2021-05-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:44:09

Label at a glance#

ProductArtificial Tears
Active ingredientPOLYVINYL ALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

you experience 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 reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5499

NDC: 50090-5499-0 15 mL in a BOTTLE, DROPPER / 1 in a CARTON

ARTIFICIAL TEARS (POLYVINYL ALCOHOL, UNSPECIFIED) SOLUTION/ DROPS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5499-02023-02-07C16284748780-1f386c64a-3993-0266-e053-dadaa90a7c1a9797d1c8-9069-4570-ae82-aef89c97d0eb
50090-5499-02023-01-30C16284748780-1f386c64a-3993-0266-e053-dadaa90a7c1a9797d1c8-9069-4570-ae82-aef89c97d0eb

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-060-12ML - Milliliter17478-0601b26c764-2c19-44d1-b351-6c2c66fdc2a812012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-549950090-5499-0
17478-060

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
daf392b0-3538-47bd-a29b-7f7c0bb2910c9797d1c8-9069-4570-ae82-aef89c97d0eb2023-02-06WarningsExact identifier
spl set id: 9797d1c8-9069-4570-ae82-aef89c97d0eb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.