FDA.reportPublic FDA data

VISINE

Manufacturer
Savings Distributors LLC
Effective date
2026-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
weekly-update
Hydrated at
2026-07-17 21:43:24

Label at a glance#

ProductVisine Red Eye Hydrating Comfort Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400
Label structure10 sections

Indications and uses

for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredient . . . . . . . . . Purpose

Polyethylene glycol 400 1% Lubricant

Tetrahydrozoline HCl 0.05% Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain • redness or irritation of the eye lasts
  • changes in vision occur • 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, hypromellose, magnesium chloride, polyquaternium-42, potassium chloride, purified water, sodium citrate, sodium lactate, sodium phosphate dibasic

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

Made in Belgium @ J&JCI 2020 www.visine.com

Product is repackaged and distributed with permission of manufacturer by Savings Distributors LLC.,

85 Hoffman Lane, Suite L & M, Islandia, NY 11749

Telephone # 1-800-628-9375. Business Hours 10:00 AM - 6:30 PM

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

VISINE ®
RED EYE
HYDRATING
COMFORT
LUBRICANT/REDNESS RELIEVER EYE DROPS

WORKS IN 30 SECONDS
Redness + Irritation Relief

Lubricates &
Refreshes
STERILE
0.28 FL OZ (8 mL)

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix30030142018 Visine label.jpg

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73097-01873097-018-90
69968-0356

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
GLYCERINPDC6A3C0OXIACT
GLYCINETE7660XO1CIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POLIXETONIUM CHLORIDERNW5AM67C0IACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM LACTATETU7HW0W0QTIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Savings Distributors LLC558178eb-1eec-af0f-e063-6394a90afad92026-06-01WarningsExact identifier
ndc (package): 73097-018-90
ndc (product): 73097-018
ndc11 (package): 73097001890
spl id: 558178eb-1eed-af0f-e063-6394a90afad9
spl set id: 558178eb-1eec-af0f-e063-6394a90afad9
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
ndc (product): 69968-0356

Reported adverse events (FAERS/openFDA)#

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