Artifical Tears

Manufacturer
medsource pharmaceuticals
Effective date
2018-12-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:57:53

Label at a glance#

ProductArtifical Tears
Active ingredientPOLYVINYL ALCOHOL, POVIDONE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                                  Purpose

Polyvinyl alcohol 0.5%............................Lubricant

Povidone 0.6%......................................Lubricant

OTC - PURPOSE SECTION

Uses

  • For the temporary relief of burning & irritation due to dryness of the eye
  • For use as a protectant against further irritation or to relieve dryness of the eye

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • if solution changes color or becomes cloudy.

OTC - WHEN USING SECTION

When using this product

  • to avoid contamination, do not touch tip to any surface
  • replace cap after using

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of 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 room temperature
  • remove contact lenses before using

INACTIVE INGREDIENT SECTION

Inactive ingredients

benzlkonium chloride, dibasic sodium phosphate hydrate, edetate disodium, glucose, hydrochloric acid, monobasic sodium phosphate, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate hydrate, sodium hydroxide

DOSAGE & ADMINISTRATION SECTION

Distributed by:

Geiss, Destin & Dunn, Inc.

Peachtree, City, GA 30269

www.valuelabels.com

1-866-696-0957

Made in Korea

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-744-012025-01-30C16284748780-12cef2736-75e9-d83d-e063-dadaa90ab31f7d77bb0b-654d-904d-e053-2a91aa0a5543

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-744-01Artifical Tears1 in 1 PACKAGESOLUTION/ DROPS12
45865-744-01Artifical Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-744ARTIFICAL TEARS (POLYVINYL ALCOHOL, AND POVIDONE) SOLUTION/ DROPS [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 2 package rows20181221_7d77bb0b-654d-904d-e053-2a91aa0a5543.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-017-05ML - Milliliter50804-017a3e6d87d-d28f-48bb-96c0-24273bc46e1b12018-04-19

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
45865-74445865-744-01
50804-017

Ingredients#

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

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

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
7d77bb22-3b4b-867d-e053-2a91aa0aee657d77bb0b-654d-904d-e053-2a91aa0a55432018-12-20WarningsExact identifier
spl id: 7d77bb22-3b4b-867d-e053-2a91aa0aee65
spl set id: 7d77bb0b-654d-904d-e053-2a91aa0a5543

Reported adverse events (FAERS/openFDA)#

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