FDA.reportPublic FDA data

artificial tears

Manufacturer
RITE AID CORPORATION | Bausch & Lomb Incorporated
Effective date
2024-07-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:39

Label at a glance#

Productartificial tears
Active ingredientGLYCERIN, PROPYLENE GLYCOL
Label structure10 sections

Indications and uses

temporary relief of burning and irritation due to dryness of the eye prevents further irritation

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

Glycerin (0.3%)
Propylene glycol (1.0%)

Purpose

OTC - PURPOSE SECTION

Lubricant
Lubricant

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of burning and irritation due to dryness of the eye
  • prevents further irritation

Warnings

WARNINGS SECTION

For external use only

Do not use

  • if solution changes color or becomes cloudy

When using this product

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

Stop use and ask a doctor if

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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

OTHER SAFETY INFORMATION

  • store at 15-25°C (59-77°F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride (0.01%), boric acid, edetate disodium, potassium chloride, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call: 1-866-767-8975

DISTRIBUTED BY:
RITE AID,
30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.com

Principal Display Panel – 30 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RiteAid CartonRiteAid CartonARTIFICIAL
TEARS

lubricant eye drops

soothing relief for
dryness and irritation

STERILE
1 FL OZ (30 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionPSN4
259195glycerin 3 MG/ML / propylene glycol 10 MG/ML Ophthalmic SolutionSCD4
259195glycerin 0.3 % / propylene glycol 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
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
11822-0011-3artificial tears30 mL in 1 BOTTLESOLUTION/ DROPS304
11822-0011-3artificial tears1 in 1 CARTONSOLUTION/ DROPS14
11822-0011-5artificial tears1 in 1 CARTONSOLUTION/ DROPS14
11822-0011-5artificial tears15 mL in 1 BOTTLESOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0011ARTIFICIAL TEARS (LUBRICANT EYE DROPS) SOLUTION/ DROPS [RITE AID CORPORATION]4Legacy NDC, 4 package rows20240720_fd799b50-68ac-4d9a-8975-d0bfa465a4c3.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-001111822-0011-3, 11822-0011-5

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
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB

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
1d8a01a6-6c22-16d5-e063-6294a90aacb8fd799b50-68ac-4d9a-8975-d0bfa465a4c32024-07-18WarningsExact identifier
spl id: 1d8a01a6-6c22-16d5-e063-6294a90aacb8
spl set id: fd799b50-68ac-4d9a-8975-d0bfa465a4c3

Reported adverse events (FAERS/openFDA)#

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