FDA.reportPublic FDA data

Eye Irrigating

Manufacturer
Rugby Laboratories | Geri-Care Pharmaceuticals, Corp
Effective date
2018-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:43:08

Label at a glance#

ProductEye Irrigating
Active ingredientWATER
Label structure9 sections

Indications and uses

washes the eye to help relieve irritation stinging discomfort itching by removing loose foreign material air pollutants (smog or pollen) chlorinated water

Dosage and administration

For use without the eye cup flush the affected eye(s) as needed control the rate of flow of solution by placing pressure on the bottle ------------------------------------------------------------------------------ rinse the cup with Eye Irrigating Solution immediately before each use avoid contamination of the rim and inside surfaces of the cup fill the cup half full with Eye Irrigating Solution and apply the cup ...

Storage and handling

store at room temperature 15° - 25°C (59° - 77°F) keep tightly closed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water (99.05%)

Purpose

OTC - PURPOSE SECTION

Eyewash

Uses

INDICATIONS & USAGE SECTION

washes the eye to help relieve

  • irritation
  • stinging
  • discomfort
  • itching

by removing

  • loose foreign material
  • air pollutants (smog or pollen)
  • chlorinated water

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • remove contact lenses before using
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain, changes in vision, continued redness or irritation of the eye
  • condition worsens or persists
  • you have open wounds in or near the eye. Get medical help right away.

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

For use without the eye cup

  • flush the affected eye(s) as needed
  • control the rate of flow of solution by placing pressure on the bottle

wo cupwo cup

------------------------------------------------------------------------------



cupcup

When using an eye cup

OTC - WHEN USING SECTION

  • rinse the cup with Eye Irrigating Solution immediately before each use
  • avoid contamination of the rim and inside surfaces of the cup
  • fill the cup half full with Eye Irrigating Solution and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
  • tilt the head backward. Open eyelids wide and rotate eyeball to thoroughly wash the eye
  • rinse the cup with clean water after each use

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15° - 25°C (59° - 77°F)
  • keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

Question or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby

NDC 0536-1126-97

Compare to the active ingredient in Bausch + Lomb Advanced Eye Relief® Eye Wash*

GENTLE CLEANSING SOLUTION
FOR EVERYDAY USE

Eye
Irrigating
Solution

Eases Irritation
Soothes Burning & Stinging
Relieves Itching

THIMEROSAL FREE
Isotonic

Sterile eye cup enclosed

STERILE

4 FL OZ (118 mL)

eye washeye wash

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1126-97ML - Milliliter0536-1126e82ef16b-3098-4d9e-adae-ae690d1b0f9512017-08-11

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-11260536-1126-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROCHLORIC ACIDQTT17582CBIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYAMINOPROPYL BIGUANIDE322U039GMFIACT
WATER059QF0KO0RACTIB

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
7cd5c860-9144-08a7-e053-2991aa0a566c4f04cd6b-1b23-2091-e054-00144ff88e882018-12-12WarningsExact identifier
spl id: 7cd5c860-9144-08a7-e053-2991aa0a566c
spl set id: 4f04cd6b-1b23-2091-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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