FDA.reportPublic FDA data

CareOne Artificial Tears Eye Drops 15mL

Manufacturer
Retail Business Services, LLC | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:30:25

Label at a glance#

ProductCareOne Artificial Tears Eye Drops 15mL
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE
Label structure9 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 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%

Purposes

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 exposure to wind or sun

Warnings

WARNINGS SECTION

For external use only

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.

Do not use this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

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, sodium phosphate monobasic

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

CareOne Artificial Tears

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CareOne Artificial TearsCareOne Artificial Tears

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSN3
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD3
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041520118653GTIN-13: 0041520118653
EAN-13: 0041520118653
GTIN-12: 041520118653
UPC-A: 041520118653
GTIN storage (14 digits): 00041520118653		KC DL - CareOne Artificial Tears 15mL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-038-01CareOne Artificial Tears Eye Drops 15mL1 in 1 BOXSOLUTION/ DROPS13
72476-038-01CareOne Artificial Tears Eye Drops 15mL15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-03872476-038-01

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
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CITRATE1Q73Q2JULRIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSKH7I04HPUUIACT
POVIDONEFZ989GH94EACTIB
DEXTROSEIY9XDZ35W2IACT
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT

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
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
ndc (package): 72476-038-01
ndc (product): 72476-038
ndc11 (package): 72476003801
spl id: 474934f1-049e-4853-e063-6294a90ad238
spl set id: 92fded6b-91fd-d82e-e053-2a95a90ab523

Reported adverse events (FAERS/openFDA)#

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