Fendall 2000 Pure Flow

Manufacturer
Honeywell Safety Products USA, Inc. | Keystone Industries
Effective date
2024-01-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:06:47

Label at a glance#

ProductFendall 2000 Pure Flow
Active ingredientWATER
Label structure8 sections

Indications and uses

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

Dosage and administration

pull handle on the activating door to initiate flow lower head into flow for 15 minutes if necessary, continue flushing with emergency eyewash or shower do not reuse discard cartridge after use

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified Water 98.6%

Purpose

OTC - PURPOSE SECTION

Emergency Eyewash

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

  • store at room temperature, 59 o to 86 oF (15 o to 30 oC)
  • do not freeze

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or gets cloudy
  • in open wounds in or near the eyes
  • with contact lenses

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

  • changes in vision
  • eye pain
  • continued redness, irritation of the eye 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

  • pull handle on the activating door to initiate flow
  • lower head into flow for 15 minutes
  • if necessary, continue flushing with emergency eyewash or shower
  • do not reuse
  • discard cartridge after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

Call 1-800-430-5490

Sperian Eye & Face Protecton, Inc.

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fendall 2000Fendall 2000Fendall 2000 PIFendall 2000 PI

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053173water 98.6 % Ophthalmic Irrigation SolutionPSN5
1053173water 986 MG/ML Ophthalmic Irrigation SolutionSCD5
1053173water 98.577 % Ophthalmic Irrigation SolutionSY5
1053173water 98.6 % Ophthalmic Irrigation SolutionSY5
1053173water 98.6 ML per 100 ML Ophthalmic Irrigation SolutionSY5

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
0498-0631-372024-01-06C16284748780-10191ceaa-69c6-198a-e063-dbdaa90aec3e0498-0631: Fendall 2000 Pure flow
0498-0631-372023-07-28C16284748780-10191ceaa-69c6-198a-e063-dbdaa90aec3e0498-0631: Fendall 2000 Pure flow

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0498-0631-37Fendall 2000 Pure Flow29.9 L in 1 CONTAINERLIQUID29.95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0498-0631FENDALL 2000 PURE FLOW (PURIFIED WATER) LIQUID [HONEYWELL SAFETY PRODUCTS USA, INC.]5Current NDC, Legacy NDC, 1 package rows20240107_b56ef662-fec2-4d94-e053-2995a90aba2b.zip

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
0498-06310498-0631-37

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

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
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.b56ef662-fec2-4d94-e053-2995a90aba2b2024-01-06WarningsExact identifier
ndc (package): 0498-0631-37
ndc (product): 0498-0631
ndc11 (package): 00498063137
spl id: 0e4a17cb-beaf-6525-e063-6394a90a16b0
spl set id: b56ef662-fec2-4d94-e053-2995a90aba2b

Reported adverse events (FAERS/openFDA)#

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