FDA.reportPublic FDA data

Visine Dry Eye Relief

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:37:06

Label at a glance#

ProductVisine Dry Eye Relief
Active ingredientPOLYETHYLENE GLYCOL 400
Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed children under 6 years of age: consult a doctor

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Purpose

OTC - PURPOSE SECTION

Lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • remove contact lenses before using
  • do not use if this solution changes color or becomes cloudy
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye lasts
  • condition worsens 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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 6 years of age and over: put 1 or 2 drops in the affected eye(s) as needed
  • children under 6 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

call toll-free 888-734-7648 or 215-273-8755 (collect)

SPL UNCLASSIFIED SECTION

Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VISINE ®

DRY EYE RELIEF

LUBRICANT EYE DROPS

MOISTURIZES +

SOOTHES DRY, GRITTY

EYES

Designed to work

Like Real

Tears

STERILE

1/2 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360899polyethylene glycol 400 1 % Ophthalmic SolutionPSN5
2360899polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD5
2360899polyethylene glycol 400 1 % Ophthalmic SolutionSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0363-1Visine Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS15
69968-0363-1Visine Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155
69968-0363-2Visine Dry Eye Relief2 in 1 CARTONSOLUTION/ DROPS25
69968-0363-2Visine Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0363VISINE DRY EYE RELIEF (POLYETHYLENE GLYCOL 400) SOLUTION/ DROPS [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 4 package rows20241115_2de7a41d-661d-495f-89b4-5690664a3a3d.zip

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
69968-036369968-0363-1, 69968-0363-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
GLYCERINPDC6A3C0OXIACT
GLYCINETE7660XO1CIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM LACTATETU7HW0W0QTIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB

Source Document#

Source XML · Source PDF

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
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
ndc (package): 69968-0363-1
ndc11 (package): 69968036301
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
ndc (package): 69968-0363-2
ndc (package): 69968-0363-1
ndc (product): 69968-0363
ndc11 (package): 69968036302
ndc11 (package): 69968036301
spl id: 21d86989-6e91-fc66-e063-6294a90a5ad5
spl set id: 2de7a41d-661d-495f-89b4-5690664a3a3d

Reported adverse events (FAERS/openFDA)#

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