Eyesaline Concentrate

Manufacturer
Sperian Eye & Face Protection Inc. | Sperian Eye & Face Protection Inc
Effective date
2018-03-21
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 22:54:58

Label at a glance#

ProductEyesaline Concentrate
Active ingredientWATER
Label structure9 sections

Indications and uses

For flushing or irrigating the eye to remove loose foreign material, air pollutants, or chlorinated water.

Dosage and administration

Concentrate must be diluted (1) part concentrate to (10) parts potable water before use Prepare sufficient quantity of constituted eyewash solution in advance of an emergency Mix concentrate with potable water to prepare eyewash solution as follows: Determine quantity of eyewash solution required Follow sanitary procedures Wear protective eyewear and gloves Pour 1/3 of required amount of potable water into mixing ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 93%

Purpose

OTC - PURPOSE SECTION

Eyewash

Uses

INDICATIONS & USAGE SECTION

  • For flushing or irrigating the eye to remove loose foreign material, air pollutants, or chlorinated water.

Warnings

WARNINGS SECTION

For external use only- Obtain immidiate medical treatment for all open wounds in or near the eyes. To avoid contamination, do not touch tip of container to any surface. Replace cap after use.

Do not use

OTC - DO NOT USE SECTION

  • in concentrated form
  • while wearing contact lenses
  • if solution changes color or becomes cloudy
  • for injection
  • in intraocular surgery
  • internally
  • if eye is lacerated or object is embedded
  • if seal is broken

Stop use and consult a doctor if you have

OTC - STOP USE SECTION

  • changes in vision
  • continued reddness, irritation or pain, or if the condition worsens or persists

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

  • Concentrate must be diluted (1) part concentrate to (10) parts potable water before use
  • Prepare sufficient quantity of constituted eyewash solution in advance of an emergency
  • Mix concentrate with potable water to prepare eyewash solution as follows:
  • Determine quantity of eyewash solution required
  • Follow sanitary procedures
  • Wear protective eyewear and gloves
  • Pour 1/3 of required amount of potable water into mixing container or eyewash unit
  • Add 1/3 of required amount of concentrate to water
  • Agitate or mix thoroughly
  • ​Repeat until required amount of solution is prepared
  • Properly dispose of empty bottle after use

Do not reuse.

  • Replace solution no longer than (6) months after mixing

Other information

OTHER SAFETY INFORMATION

Do not freeze

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, edetate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

Questions?

OTC - QUESTIONS SECTION

Call 1-800-430-5490

Sperian Eye and Face Protection Inc

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EyeSalineConcentrateEyeSalineConcentrate

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150133water 92.2 % Concentrate for Ophthalmic Irrigation SolutionPSN8
1150133water 922 MG/ML Ophthalmic Irrigation SolutionSCD8
1150133water 92.2 % Concentrate for Ophthalmic Irrigation SolutionSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64809-104-182020-01-31C16284748780-19d75b9d0-3dc0-f424-e053-dadaa90a57ceSperian Eyesaline Concentrate
64809-104-192020-01-31C16284748780-19d75b9d0-3dc0-f424-e053-dadaa90a57ceSperian Eyesaline Concentrate

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64809-104-18Eyesaline Concentrate2070 mL in 1 BOTTLE, PLASTICLIQUID20708
64809-104-19Eyesaline Concentrate5323 mL in 1 BOTTLE, PLASTICLIQUID53238

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64809-104EYESALINE CONCENTRATE (WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC.]8Legacy NDC, 2 package rows20180321_b17d1415-e643-4f2f-b202-e46c6ec68d0c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0R3
WATERACTIVE MOIETY059QF0KO0R3
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W73
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X3
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F3
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RN3

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64809-10464809-104-18, 64809-104-19

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 319 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM, SOLUBLE / ORAL0.05 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, SUSPENSION / INTRA-ARTICULAR13 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / TOPICAL0.46 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET / ORAL96 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / OPHTHALMIC2 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, EXTENDED RELEASE / ORAL335.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INFILTRATION3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KELIXIR / ORAL1.3 mg/5mlExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / SUBCUTANEOUS0.07 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRATYMPANIC2 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SUSPENSION/ DROPS / AURICULAR (OTIC)0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / OPHTHALMIC0.08 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, EMULSION / INTRAVENOUS0.28 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSYRUP / ORAL70 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / OPHTHALMIC396 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / AURICULAR (OTIC)18 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSUSPENSION / OPHTHALMIC0.04 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / ORALNAExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRASYNOVIAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION/ DROPS / TOPICAL0.23 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS6 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNSOLUTION / ORAL1500 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
BENZALKONIUM CHLORIDEBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii candidate
24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINHALANT / RESPIRATORY (INHALATION)3 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / SOFT TISSUE3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNINJECTION / INTRAVASCULAR0.15 mgExact identifier — unii candidate
36 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRALESIONAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATESODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNTABLET, FILM COATED / ORAL0.11 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / SUBCUTANEOUS2 mgExact identifier — unii candidate
77 equally ranked IID candidates

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
67eba057-1aa4-1604-e053-2991aa0a1d0bb17d1415-e643-4f2f-b202-e46c6ec68d0c2018-03-21WarningsExact identifier
spl id: 67eba057-1aa4-1604-e053-2991aa0a1d0b
spl set id: b17d1415-e643-4f2f-b202-e46c6ec68d0c

Reported adverse events (FAERS/openFDA)#

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