Artificial Tears

Manufacturer
American Sales Company
Effective date
2019-10-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:01:20

Label at a glance#

ProductArtificial Tears
Active ingredientGLYCERIN, POLYETHYLENE GLYCOL 400, HYPROMELLOSES
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.

Storage and handling

Do not use if the tamper-resistant bottle cap is broken or opened. RETAIN THIS CARTON FOR FUTURE REFERENCE store between 15° to 30°C (59°F to 86°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene Glycol 400 1%

Purpose

OTC - PURPOSE SECTION

Lubricant

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

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

When using this product

OTC - WHEN USING SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

  • Do not use if the tamper-resistant bottle cap is broken or opened.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • store between 15° to 30°C (59°F to 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aminoacetic acid, ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Package principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Care One Tears

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259581glycerin 0.2 % / hypromellose 0.2 % / polyethylene glycol 400 1 % Ophthalmic SolutionPSN4
259581glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD4
259581glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic SolutionSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
41520-865-052022-01-28C16284748780-1d6a99b39-6aff-a426-e053-dadaa90af4c2CareOne Artificial Tears

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-865-05Artificial Tears15 mL in 1 BOTTLELIQUID154
41520-865-05Artificial Tears1 in 1 BOXLIQUID14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-865ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]4Legacy NDC, 2 package rows20191029_4c62432b-bd6d-46ac-a5fb-8dadfda04846.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OX2
HYPROMELLOSESACTIVE INGREDIENT3NXW29V3WO2
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ2
GLYCERINACTIVE MOIETYPDC6A3C0OX2
HYPROMELLOSESACTIVE MOIETY3NXW29V3WO2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQ2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0R2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W72
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D42
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W22
GLYCINEINACTIVE INGREDIENTTE7660XO1C2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I102
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41520-86541520-865-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 279 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10INJECTION / INTRAMUSCULAR0.4 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2SPRAY, METERED / NASAL50 mgExact identifier — unii candidate
21 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / NASAL40.46 mg/100mlExact identifier — unii candidate
24 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPOWDER, FOR SUSPENSION / ORAL400 mgExact identifier — unii candidate
20 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRAVENOUS51.7 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / IRRIGATION0.04 %w/vExact identifier — unii candidate
18 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10CAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RGEL / TOPICAL7 mgExact identifier — unii candidate
25 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RSOLUTION / TOPICAL0.04 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10TABLET / ORAL231 mgExact identifier — unii candidate
18 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CCAPSULE, DELAYED RELEASE / ORAL50 mgExact identifier — unii candidate
20 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4DROPS / OPHTHALMIC1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2INJECTION, SOLUTION / INTRATHECAL1925 mgExact identifier — unii candidate
21 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRATHECAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
DEXTROSEDEXTROSEIY9XDZ35W2TABLET / SUBLINGUAL115.78 mgExact identifier — unii candidate
21 equally ranked IID candidates
ASCORBIC ACIDASCORBIC ACIDPQ6CK8PD0RAEROSOL, METERED / RESPIRATORY (INHALATION)0.1 %w/wExact identifier — unii candidate
25 equally ranked IID candidates
SODIUM LACTATESODIUM LACTATETU7HW0W0QTINJECTION / INTRAVENOUS54 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOCREAM / TOPICALNAExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC0.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS200 mgExact identifier — unii candidate
20 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION / OPHTHALMIC60 mgExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
6 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRATUMOR1.2 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGEL / VAGINAL10 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7LIQUID / NASAL0.2 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSHAMPOO / TOPICAL150 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCINEGLYCINETE7660XO1CPASTE, DENTIFRICE / DENTAL0.34 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SPRAY, METERED / NASAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
BORIC ACIDBORIC ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER / TOPICALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS2922 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVENOUS0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
9602d650-fc3f-0931-e053-2995a90a80584c62432b-bd6d-46ac-a5fb-8dadfda048462019-10-28WarningsExact identifier
spl id: 9602d650-fc3f-0931-e053-2995a90a8058
spl set id: 4c62432b-bd6d-46ac-a5fb-8dadfda04846

Reported adverse events (FAERS/openFDA)#

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