FDA.reportPublic FDA data

Honeywell Sterile Eyesaline

Manufacturer
Sperian Eye & Face Protection Inc
Effective date
2018-06-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:01

Label at a glance#

ProductHoneywell Sterile Eyesaline Emergency Eyewash
Active ingredientWATER
Label structure12 sections

Storage and handling

Other information store at room temperature 59° to 86° F(15° to 30°C) do not freeze

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sterile water 99%

OTC - PURPOSE SECTION

Purpose

Emergency Eyewash

INDICATIONS & USAGE SECTION

Uses

For flushing the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination.

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use

  • for injection
  • in intraocular surgery
  • internally

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • eye pain
  • changes in vision
  • redness or irritation of the eye after use
  • an injury caused by alkali

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • do not dilute solution or reuse cartridge
  • pull handle on the activating door to initiate flow
  • lower head into flow for a minimum of 20 minutes
  • continue flushing with water if necessary
  • obtain medical treatment

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 59° to 86° F(15° to 30°C)
  • do not freeze

INACTIVE INGREDIENT SECTION

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

OTC - QUESTIONS SECTION

Questions?

call 1-800 - 430-5490

SPL UNCLASSIFIED SECTION

Sperian Eye and Face Protection, Inc. (a Honeywell Company)

825 East Highway 151
Platteville, WI 53818

SPL UNCLASSIFIED SECTION

WARNING!

FOR PROPER OPERATION:

  1. Read all warnings and the Operation and Installation Manual prior to installation of cartridges. Failure to follow this installation instructions and warnings may result in personal injury, serious illness, including blindness or death.
  2. Inspect cartridges for damage: If the nozzle assembly, flexible soluton bag and carton has been damaged, or the nozzle assembly or bag is leaking fluid, DO NOT INSTALL! Call 1-800-430-5490.
  3. The top of the carton must be unobstructed and free from damaged.
  4. Install cartridges (two required) in the Fendall Pure Flow 1000 with slot A to the rear and theh nozzle assembly in front.
  5. Each cartridge weighs 32 lbs (14.5 kg). Use caution when handling and installing.
  6. Cartridges must be replaced after use and on, or before the solution expiration date printed on the carton and activating strap.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Honeywell STERILE eyesaline®

Emergency Eyewash

Buffered Isotonic Solution

3.9 Gallons (14.4L)

Net Wt. 32 lbs (14.5kg)

EyeSaline Cartridge June 2018 FrontEyeSaline Cartridge June 2018 Front

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1314884water 99 % Ophthalmic Irrigation SolutionPSN1
1314884water 990 MG/ML Ophthalmic Irrigation SolutionSCD1
1314884water 99 % Ophthalmic Irrigation SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64809-103-142020-01-31C16284748780-19d75b9d0-7f2a-f424-e053-dadaa90a57ceSperian Eyesaline Emergency Eyewash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64809-103-14Honeywell Sterile EyesalineEmergency Eyewash14.4 L in 1 CARTRIDGELIQUID14.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64809-103HONEYWELL STERILE EYESALINE EMERGENCY EYEWASH (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]1Legacy NDC, 1 package rows20180620_6f045033-91c8-e469-e053-2991aa0ac7dc.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64809-10364809-103-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, MONOBASIC3980JIH2SWIACT
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
6f045033-91b9-e469-e053-2991aa0ac7dc6f045033-91c8-e469-e053-2991aa0ac7dc2018-06-19WarningsExact identifier
spl id: 6f045033-91b9-e469-e053-2991aa0ac7dc
spl set id: 6f045033-91c8-e469-e053-2991aa0ac7dc

Reported adverse events (FAERS/openFDA)#

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