FDA.reportPublic FDA data

Artificial Tears

Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:25:28

Label at a glance#

ProductArtificial Tears
Active ingredientGLYCERIN, HYPROMELLOSES, POLYETHYLENE GLYCOL 400
Label structure13 sections

Indications and uses

for protection against further irritation for temporary relief of burning and irritation due to dryness of the eye

Dosage and administration

instill 1 or 2 drops in the affected eye(s) as needed children under 6 years of age: ask a doctor

Storage and handling

store at 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

  • for protection against further irritation
  • for temporary relief of burning and irritation due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this product if solution changes color or becomes cloudy

OTC - WHEN USING SECTION

When using this product

  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
  • remove contact lenses before using

OTC - STOP USE SECTION

Stop use and ask a doctor if 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

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 reach of children. If swallowed, get medical help or
contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • 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

1-800-540-3765

package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130368071455557GTIN-13: 0368071455557
EAN-13: 0368071455557
GTIN-12: 368071455557
UPC-A: 368071455557
GTIN storage (14 digits): 00368071455557		68071-4555-5.jpg
Data codeData Matrix0100368071455557210000000002<GS>170000010000000<GS>68071-4555-5.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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4555-52024-06-11C16284748780-1ba0f9c33-3483-a910-e053-dadaa90a0b85GC Artificial Tears 181
68071-4555-52023-01-30C16284748780-1ba0f9c33-3483-a910-e053-dadaa90a0b85GC Artificial Tears 181
68071-4555-52021-02-19C16284748780-1ba0f9c33-3483-a910-e053-dadaa90a0b85GC Artificial Tears 181
68071-4555-52021-01-29C16284748780-1ba0f9c33-3483-a910-e053-dadaa90a0b85GC Artificial Tears 181

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4555-5Artificial Tears15 mg in 1 BOTTLESOLUTION/ DROPS154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-181-05ML - Milliliter57896-1813d6720e0-87d1-4860-bd06-d8a3cf79172012018-12-13

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
68071-455568071-4555-5
57896-181

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEXTROSEIY9XDZ35W2IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TIACT
SODIUM BICARBONATE8MDF5V39QOIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE1Q73Q2JULRIACT
GLYCERINPDC6A3C0OXACTIB
HYPROMELLOSES3NXW29V3WOACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
ndc (product): 57896-181
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
ndc (package): 68071-4555-5
ndc (product): 68071-4555
ndc11 (package): 68071455505
spl id: 46050426-880b-d28c-e063-6294a90acc56
spl set id: 97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d

Reported adverse events (FAERS/openFDA)#

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