FDA.reportPublic FDA data

CVS Lubricant Eye Drops Ultra

Manufacturer
CVS | K.C. Pharmaceutical, Inc. | KC Pharmaceuticals, Inc. | Unimed Pharmaceuticals, Inc.
Effective date
2023-12-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:05:36

Label at a glance#

ProductCVS Lubricant Eye Drops Ultra
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Polyethylene glycol 400.........0.4%

Propylene glycol ...................0.3%

OTC - PURPOSE SECTION

Purposes

Polyethylene glycol 400......Lubricant

Propylene glycol.................Lubricant

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product

  • 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(s) 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 reach of children

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

OTHER SAFETY INFORMATION

Other information

  • store at 15º-25º C (59º-77º F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

INACTIVE INGREDIENT SECTION

Inactive ingredients

boric acid, hydrochloric acid**, hypromellose, potassium chloride, purified water, sodium chloride, sodium hydroxide**

** May contain these ingredients to adjust pH.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

60 ct carton60 ct carton30 ct carton30 ct carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN6
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD6
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY6

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
69842-752-01CVS Lubricant Eye Drops Ultra30 in 1 CARTONSOLUTION306
69842-752-01CVS Lubricant Eye Drops Ultra0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.46
69842-752-02CVS Lubricant Eye Drops Ultra60 in 1 CARTONSOLUTION606
69842-752-02CVS Lubricant Eye Drops Ultra0.4 mL in 1 VIAL, SINGLE-USESOLUTION0.46

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-752CVS LUBRICANT EYE DROPS ULTRA (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION [CVS]6Legacy NDC, 4 package rows20231224_bb1b936e-5e41-9d18-e053-2a95a90a4a86.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-75269842-752-01, 69842-752-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
HYDROCHLORIC ACIDQTT17582CBIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
BORIC ACIDR57ZHV85D4IACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
WATER059QF0KO0RIACT

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
0d376b0b-0989-5527-e063-6394a90acce9bb1b936e-5e41-9d18-e053-2a95a90a4a862023-12-23WarningsExact identifier
spl id: 0d376b0b-0989-5527-e063-6394a90acce9
spl set id: bb1b936e-5e41-9d18-e053-2a95a90a4a86

Reported adverse events (FAERS/openFDA)#

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