FDA.reportPublic FDA data

Quality Choice Artificial Tears Lubricant Eye Drops

Manufacturer
Chain Drug Marketing Association, Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:29:52

Label at a glance#

ProductQuality Choice Artificial Tears Lubricant Eye Drops
Active ingredientPOLYVINYL ALCOHOL, POVIDONE
Label structure8 sections

Indications and uses

for use as a protectant against further irritation or to relieve dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings

WARNINGS SECTION

For external use only

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • remove contact lens before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using. Keep container tightly closed

Stop use and ask a doctor if you experience

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

  • Store at 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

Quality Choice Artificial Tears Lubricant Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice Artificial Tears Lubricant Eye Drops 15mLQuality Choice Artificial Tears Lubricant Eye Drops 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSN2
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD2
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130635515992238GTIN-13: 0635515992238
EAN-13: 0635515992238
GTIN-12: 635515992238
UPC-A: 635515992238
GTIN storage (14 digits): 00635515992238		Quality Choice Artificial Tears (New NDC).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-189-14Quality Choice Artificial Tears Lubricant Eye Drops1 in 1 BOXSOLUTION/ DROPS12
83324-189-14Quality Choice Artificial Tears Lubricant Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-189-14ML - Milliliter83324-1893426e42f-7268-4575-992a-3455aee67e8212025-05-14

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-18983324-189-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POLYVINYL ALCOHOL532B59J990ACTIB
POVIDONEFZ989GH94EACTIB

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
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
ndc (package): 83324-189-14
ndc (product): 83324-189
ndc11 (package): 83324018914
spl id: 47494778-349f-6448-e063-6294a90a3c34
spl set id: 1f669655-4bc7-0175-e063-6294a90a305a

Reported adverse events (FAERS/openFDA)#

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