FDA.reportPublic FDA data

Naturally Inspired Irritated Eye Relief

Manufacturer
Similasan Corporation
Effective date
2025-10-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:51:09

Label at a glance#

ProductNaturally Inspired Irritated Eye Relief
Active ingredientHYDROXYETHYL CELLULOSE, UNSPECIFIED
Label structure9 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 well 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#

Active Ingredient

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 well 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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Similasan

Irritated Eye Relief
Sterile Lubricant Eye Drops

0.33 FL OZ (10ml)

Similasan Irritated Eye Relief Sterile Lubricant Eye Drops 0.33 FL OZ (10ml)Similasan Irritated Eye Relief Sterile Lubricant Eye Drops 0.33 FL OZ (10ml)

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
59262-80159262-801-11

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
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DACTIB
CITRIC ACID2968PHW8QPIACT
ECTOIN7GXZ3858RYIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

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
4c4dd30b-75ae-93ac-e063-6294a90a57134f7ef5e6-ddc5-446f-840f-1740cd58bfdc2026-03-05WarningsExact identifier
spl set id: 4f7ef5e6-ddc5-446f-840f-1740cd58bfdc

Reported adverse events (FAERS/openFDA)#

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