FDA.reportPublic FDA data

Family Wellness Artificial Tears

Manufacturer
Family Dollar Services, Inc. | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:30:57

Label at a glance#

ProductFamily Wellness Artificial Tears
Active ingredientPOVIDONE, POLYVINYL ALCOHOL, UNSPECIFIED
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 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%

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 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

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 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

Family Wellness Artificial Tears 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Family Wellness Artificial Tears 15mLFamily Wellness Artificial Tears 15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSN4
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD4
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130032251912641GTIN-13: 0032251912641
EAN-13: 0032251912641
GTIN-12: 032251912641
UPC-A: 032251912641
GTIN storage (14 digits): 00032251912641		Family Wellness Artificial Tears 15mL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-908-01Family Wellness Artificial Tears1 in 1 BOXSOLUTION/ DROPS14
55319-908-01Family Wellness Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

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
55319-90855319-908-01

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
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POTASSIUM CHLORIDE660YQ98I10IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
SODIUM CITRATE1Q73Q2JULRIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
POVIDONEFZ989GH94EACTIB
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB

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
Family Wellness Artificial TearsPOLYVINYL ALCOHOL, POVIDONEFamily Dollar Services, Inc.facd329b-1923-61df-e053-6294a90ab7382025-12-30WarningsExact identifier
ndc (package): 55319-908-01
ndc (product): 55319-908
ndc11 (package): 55319090801
spl id: 474528d1-7e7b-a211-e063-6294a90ae3c5
spl set id: facd329b-1923-61df-e053-6294a90ab738

Reported adverse events (FAERS/openFDA)#

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