FDA.reportPublic FDA data

CVS Health Fast Acting Lubricant Eye Drops

Manufacturer
CVS Pharmacy, Inc. | K.C. Pharmaceuticals, Inc. | K.C. Pharmaceuticals, Inc
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:25

Label at a glance#

ProductCVS Health Fast Acting Lubricant Eye Drops
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Polyethylene glycol 400......0.4%

Propylene glycol......0.3%

OTC - PURPOSE SECTION

Purpose

Polyethylene glycol 400......Lubricant

Propylene glycol......Lubricant

INDICATIONS & USAGE SECTION

Use

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

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if this product 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-30°C (59°-86ºF)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aminomethylpropanol, benzalkonium chloride as preservative, boric acid, hypromellose, potassium chloride, sorbitol

CVS Health Fast Acting Lubricant Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Fast Acting Lubricant Eye Drops 15mLCVS Health Fast Acting Lubricant Eye Drops 15mL

CVS Health Fast Acting Lubricant Eye Drops 15mL twin pk

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Health Fast Acting Lubricant Eye Drops 15mL twin pkCVS Health Fast Acting Lubricant Eye Drops 15mL twin pk

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN1
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD1
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY1

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product 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
51316-659-01CVS Health Fast Acting Lubricant Eye Drops1 in 1 BOXSOLUTION/ DROPS11
51316-659-01CVS Health Fast Acting Lubricant Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151
51316-659-02CVS Health Fast Acting Lubricant Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS151
51316-659-02CVS Health Fast Acting Lubricant Eye Drops2 in 1 BOXSOLUTION/ DROPS21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-659CVS HEALTH FAST ACTING LUBRICANT EYE DROPS (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CVS PHARMACY, INC.]1Current NDC, 4 package rows20250403_31addfd2-52f2-05b3-e063-6294a90a337f.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-65951316-659-01, 51316-659-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMINOMETHYLPROPANOLLU49E6626QIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
HYPROMELLOSES3NXW29V3WOIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
SODIUM CHLORIDE451W47IQ8XIACT
SORBITOL506T60A25RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Fast Acting Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCVS Pharmacy, Inc.31addfd2-52f2-05b3-e063-6294a90a337f2024-01-01WarningsExact identifier
ndc (package): 51316-659-02
ndc (package): 51316-659-01
ndc (product): 51316-659
ndc11 (package): 51316065901
ndc11 (package): 51316065902
spl id: 31adc9c8-56bf-fc9e-e063-6294a90aa637
spl set id: 31addfd2-52f2-05b3-e063-6294a90a337f

Reported adverse events (FAERS/openFDA)#

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