FDA.reportPublic FDA data

Irritated Eye Relief

Manufacturer
Similasan Corporation
Effective date
2026-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:49:07

Label at a glance#

ProductIrritated Eye Relief Sterile Lubricant Eye Drops
Active ingredientHYDROXYETHYLCELLULOSE
Label structure10 sections

Indications and uses

For the temporary relief of burning and irritation due to dryness of the eye. For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sun. For use as a protectant against further irritation or to relieve dryness of the eye. For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Dosage and administration

Wash hands before use. Remove tamper evident ring, then remove cap. Tilt bottle downward or upside down and squeeze. Instill 1 or 2 drops in the affected eye(s) as needed. After use, tilt bottle downward and shake to remove any residual drops left on the tip of the bottle. Replace cap after using.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroxyethyl cellulose 0.35%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of burning and irritation due to dryness of the eye.
  • For the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind and sun.
  • For use as a protectant against further irritation or to relieve dryness of the eye.
  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings

WARNINGS SECTION

  • For external use only.
  • To avoid contamination, do not touch the tip of container to any surface.
  • In rare cases, hypersensitivity reactions such as redness, burning, swelling, and itching may occur.

Do not use:

OTC - DO NOT USE SECTION

  • If solution changes color or becomes cloudy
  • If tamper evident seal is broken or missing
  • If bottle is damaged
  • If you are allergic to any of the ingredients

Stop and ask a doctor if:

OTC - STOP USE SECTION

  • You experience eye pain, changes in vision, or continued redness or irritation of the eye
  • The condition worsens or persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wash hands before use.
  • Remove tamper evident ring, then remove cap.
  • Tilt bottle downward or upside down and squeeze.
  • Instill 1 or 2 drops in the affected eye(s) as needed.
  • After use, tilt bottle downward and shake to remove any residual drops left on the tip of the bottle.
  • Replace cap after using.

Other Information

OTHER SAFETY INFORMATION

  • Do not use for more than 30 days after opening.
  • Use by the expiration date on bottom of the box.
  • No ingredients of animal origin.
  • Store at 36-77°F

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Citric acid, ectoin, purified water, sodium chloride, trisodium citrate dihydrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Similasan

Irritated Eye Relief

STERILE LUBRICANT EYE DROPS

Relieves Irritation

  • Burning
  • Dryness
  • Discomfort

Preservative Free

NATURALLY INSPIRED INGREDIENTS
10 ml / 0.33 fl oz

Irritated Eye ReliefIrritated Eye Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2738731hydroxyethylcellulose 0.35 % Ophthalmic SolutionPSN1
2738731hydroxyethyl cellulose 3.5 MG/ML Ophthalmic SolutionSCD1
2738731hydroxyethylcellulose 0.35 % Ophthalmic SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-804-11Irritated Eye ReliefSterile Lubricant Eye Drops10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS101
59262-804-11Irritated Eye ReliefSterile Lubricant Eye Drops1 in 1 CARTONSOLUTION/ DROPS11

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-80459262-804-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYLCELLULOSET4V6TWG28DACTIB
ECTOIN7GXZ3858RYIACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
CITRIC ACID2968PHW8QPIACT

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
Irritated Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c4ddcdf-3037-c9cd-e063-6294a90a16d52026-03-05WarningsExact identifier
ndc (package): 59262-804-11
ndc (product): 59262-804
ndc11 (package): 59262080411
spl id: 4c4ddcdf-3038-c9cd-e063-6294a90a16d5
spl set id: 4c4ddcdf-3037-c9cd-e063-6294a90a16d5

Reported adverse events (FAERS/openFDA)#

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