Visine Red Eye Comfort

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:37:14

Label at a glance#

ProductVisine Red Eye Comfort
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure11 sections

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

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCl 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Use

INDICATIONS & USAGE SECTION

  • for the relief of redness of the eye due to minor eye irritations

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

  • 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

ascorbic acid, boric acid, dextrose, glycerin, glycine, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium borate, sodium citrate, sodium lactate, sodium phosphate dibasic

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 ®
RED EYE
COMFORT

REDNESS RELIEVER EYE DROPS

FAST ACTING
Redness Relief

STERILE
1/2 FL OZ (15mL)

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
1052943tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN4
1088126Visine 0.05 % Ophthalmic SolutionPSN4
1088126tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution [Visine]SBD4
1052943tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD4
1052943tetrahydrozoline hydrochloride 0.05 % Eye DropsSY4
1052943tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY4
1088126Visine 0.5 MG/ML Ophthalmic SolutionSY4
1088126Visine Original 0.05 % Ophthalmic SolutionSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
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9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0355-1Visine Red Eye Comfort1 in 1 CARTONSOLUTION/ DROPS14
69968-0355-1Visine Red Eye Comfort15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0355VISINE RED EYE COMFORT (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241115_d7abd7cb-e094-481f-bea5-a5983e2c9ef4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69968-0355-1ML - Milliliter69968-035571d06d08-2543-4101-956a-84cde895c2a312025-05-14

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-035569968-0355-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
ndc (package): 69968-0355-1
ndc (product): 69968-0355
ndc11 (package): 69968035501
spl id: 21d6bf1e-40c6-2b49-e063-6294a90a3ede
spl set id: d7abd7cb-e094-481f-bea5-a5983e2c9ef4

Reported adverse events (FAERS/openFDA)#

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