FDA.reportPublic FDA data

Visine Red Eye Total Comfort and Tears Dry Eye Relief

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:17

Label at a glance#

ProductVisine Red Eye Total Comfort and Tears Dry Eye Relief
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATE, UNSPECIFIED FORM, POLYETHYLENE GLYCOL 400
Label structure20 sections

Indications and uses

for the temporary relief of discomfort and redness of the eye due to minor eye irritations relieves dryness of the eye for the temporary relief of burning and irritation due to exposure to wind or sun 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) up to 4 times a day • children under 6 years of age: consult a doctor • children under 2 years of age: do not use

Storage and handling

Store at 20° to 25°C (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

VISINE ® Red Eye Total Comfort Multi-Symptom

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

Purpose

OTC - PURPOSE SECTION

Lubricant

Redness reliever

Astringent

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of discomfort and redness of the eye due to minor eye irritations
  • relieves dryness of the eye
  • for the temporary relief of burning and irritation due to exposure to wind or sun
  • for protection against further irritation

Warnings

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have narrow angle glaucoma.

When using this product

OTC - WHEN USING SECTION

• some users may experience a brief tingling sensation
• pupils may become enlarged temporarily

• overuse may cause more eye redness

• 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) up to 4 times a day

• children under 6 years of age: consult a doctor

• children under 2 years of age: do not use

Other information

STORAGE AND HANDLING SECTION

Store at 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, glycerin, hypromellose, purified water, sodium chloride, sodium citrate

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

VISINE ® Dry Eye Relief

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 - Kit Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VALUE

MULTI-PACK

VISINE ®

RED EYE

TOTAL COMFORT

MULTI-SYMPTOM

ASTRINGENT / LUBRICANT / REDNESS RELIEVER EYE DROPS

UP TO

10 HRS

COMFORT

ALL-IN ONE RELIEF

From Red, Burning,

Watery, Itchy, Dry, Gritty,

Irritated Eyes

Protects Against

Further Irritation

STERILE

Use products only

as directed.

DRY EYE

RELIEF

LUBRICANT EYE DROPS

MOISTURIZES +

SOOTHES DRY,

GRITTY EYES

Designed to Work

Like Real

Tears

1 BOTTLE: VISINE®

RED EYE TOTAL COMFORT MULTI-SYMPTOM

½ FL OZ (15 mL)

1 BOTTLE: VISINE® DRY EYE RELIEF ½ FL OZ (15 mL)

Visine_01Visine_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionPSN2
2360899polyethylene glycol 400 1 % Ophthalmic SolutionPSN2
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / zinc sulfate 2.5 MG/ML Ophthalmic SolutionSCD2
2360899polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD2
2360903polyethylene glycol 400 1 % / tetrahydrozoline hydrochloride 0.05 % / zinc sulfate 0.25 % Ophthalmic SolutionSY2
2360899polyethylene glycol 400 1 % Ophthalmic SolutionSY2
2360903polyethylene glycol 400 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML / ZnSO4 2.5 MG/ML Ophthalmic SolutionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0360-1Visine Red Eye Total Comfort and Tears Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS0.5 mg in 1mL2
69968-0360-1Visine Red Eye Total Comfort and Tears Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS15 mL0.5 mg in 1mL2
69968-0363-1Visine Red Eye Total Comfort and Tears Dry Eye Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS15 mL10 mg in 1mL2
69968-0363-1Visine Red Eye Total Comfort and Tears Dry Eye Relief1 in 1 CARTONSOLUTION/ DROPS10 mg in 1mL2
69968-0844-9Visine Red Eye Total Comfort and Tears Dry Eye Relief1 in 1 PACKAGEKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0360VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_0bc0d6e7-9195-db6b-e063-6294a90aef04.zip
69968-0363VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC]2Current NDC, Legacy NDC20241116_0bc0d6e7-9195-db6b-e063-6294a90aef04.zip
69968-0844VISINE RED EYE TOTAL COMFORT AND TEARS DRY EYE RELIEF (TETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATE) KIT [KENVUE BRANDS LLC]2Current NDC, 5 package rows20241116_0bc0d6e7-9195-db6b-e063-6294a90aef04.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-084469968-0844-9
69968-036069968-0360-1
69968-036369968-0363-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BORIC ACIDR57ZHV85D4IACT
SODIUM CITRATE1Q73Q2JULRIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSES3NXW29V3WOIACT
ZINC SULFATE, UNSPECIFIED FORM89DS0H96TBACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
SODIUM CHLORIDE451W47IQ8XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
GLYCINETE7660XO1CIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
DEXTROSEIY9XDZ35W2IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
POTASSIUM CHLORIDE660YQ98I10IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BORIC ACIDR57ZHV85D4IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM LACTATETU7HW0W0QTIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
HYPROMELLOSES3NXW29V3WOIACT
SODIUM BORATE91MBZ8H3QOIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
ndc (package): 69968-0360-1
ndc (product): 69968-0360
ndc11 (package): 69968036001
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): 69968-0360-1
ndc (package): 69968-0363-1
ndc (package): 69968-0844-9
ndc (product): 69968-0844
ndc11 (package): 69968084409
ndc11 (package): 69968036001
ndc11 (package): 69968036301
spl id: 21d23d1a-0ebb-3cb3-e063-6294a90abeb7
spl set id: 0bc0d6e7-9195-db6b-e063-6294a90aef04
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
ndc (package): 69968-0363-1
ndc (product): 69968-0363
ndc11 (package): 69968036301

Reported adverse events (FAERS/openFDA)#

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