FDA.reportPublic FDA data

Artificial Tears Solution Drug Facts

Manufacturer
A-S Medication Solutions
Effective date
2017-09-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:12:09

Label at a glance#

ProductArtificial Tears
Active ingredientPOLYVINYL ALCOHOL
Label structure11 sections

Indications and uses

relieves dryness of the eye prevents further irritation

Dosage and administration

instill 1 to 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl Alcohol 1.4%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • relieves dryness of the eye
  • prevents further irritation

Warnings

WARNINGS SECTION

  • Do not use if solution changes color or becomes cloudy
  • with contact lenses

When using this product  

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or lasts 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 to 2 drops in the affected eye(s) as needed.

Other information

SPL UNCLASSIFIED SECTION

  • store at 15° - 30°C (59° - 86°F)
  • keep tightly closed

 

Inactive ingredients

INACTIVE INGREDIENT SECTION

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-645-2158

9 am - 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number

Rugby ®

Duluth, GA 30097

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-0252

NDC: 50090-0252-0 15 mL in a BOTTLE

Polyvinyl Alcohol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1970-72ML - Milliliter0536-1970a18fb046-580c-4b7d-8649-e81dcbeaca5d12012-07-24

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-025250090-0252-0
0536-1970

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL532B59J990ACTIB
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM3980JIH2SWIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

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
a0d8e19b-e4c1-442e-96ea-2727d5f53c9e375d3039-8cbe-4252-b86b-81434e4e5aae2017-09-13WarningsExact identifier
spl id: a0d8e19b-e4c1-442e-96ea-2727d5f53c9e
spl set id: 375d3039-8cbe-4252-b86b-81434e4e5aae

Reported adverse events (FAERS/openFDA)#

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