FDA.reportPublic FDA data

GOODSENSE ARTIFICIAL TEARS

Manufacturer
Proficient Rx LP
Effective date
2024-02-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:08:42

Label at a glance#

ProductGOODSENSE ARTIFICIAL TEARS
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Uses

  • temporary relieves burning and irritations due to dryness of the eye(s)
  • protects against further irritation

WARNINGS SECTION

Warnings

For external use only.  Do not use if solution changes color or becomes cloudy or if you are sensitive to any ingredient in this product.

OTC - WHEN USING SECTION

When using this product

  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye gets worse or lasts more than 72 hours

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

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

INDICATIONS & USAGE SECTION

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • Store at 15-25C (59-77F).
  • Children under 6 years of age: Ask a doctor

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Each mL contains: Polyvinyl Alcohol 5mg/ml and Povidone 6mg/ml - lubricant

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Benzalkonium Chloride, Dextrose, Disodium Edetate, Potassium Chloride, Purified Water, Sodium Bicarbonate, Sodium Chloride, Sodium Citrate, Sodium Phosphate (Mono- and Dibasic)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

63187-298-1563187-298-15Relabeled By:

Proficient Rx LP

Thousand Oaks, CA 91320

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

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
63187-298-15GOODSENSE ARTIFICIAL TEARS1 in 1 CARTONSOLUTION14
63187-298-15GOODSENSE ARTIFICIAL TEARS15 mL in 1 BOTTLESOLUTION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-298GOODSENSE ARTIFICIAL TEARS (POLYVINYL ALCOHOL) SOLUTION [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20240216_f29c792c-6cb2-449f-b97d-6304a58dec2a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11716-0001-6ML - Milliliter11716-00013e4e87e0-9015-4a69-8b8b-611fff685a1312018-07-03

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
63187-29863187-298-15
11716-0001

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
POVIDONE, UNSPECIFIEDFZ989GH94EACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM PHOSPHATESE337SVY37IACT

Source Document#

Source XML · Source PDF

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
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
ndc (package): 63187-298-15
ndc (product): 63187-298
ndc11 (package): 63187029815
spl id: 37b6ccbe-3dab-4927-9af5-a0de1f57e8c1
spl set id: f29c792c-6cb2-449f-b97d-6304a58dec2a

Reported adverse events (FAERS/openFDA)#

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