FDA.reportPublic FDA data

Fendall 1000 Pure Flow

Manufacturer
Protective Industrial Products, Inc.
Effective date
2026-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
weekly-update
Hydrated at
2026-07-17 21:43:14

Label at a glance#

ProductFendall 1000 Pure Flow
Active ingredientWATER
Label structure9 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 98.66%

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

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

Other information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

USA: 800-430-5490

Canada: 888-212-7233

Protective Industrial Products, Inc.

25 British American Blvd.

Latham, NY 12110, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fendall 1000 artworkFendall 1000 artwork

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
80716-10080716-100-01

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
WATER059QF0KO0RACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE593YOG76RNIACT
EDETATE DISODIUM7FLD91C86KIACT

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 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
ndc (package): 80716-100-01
ndc (product): 80716-100
ndc11 (package): 80716010001
spl id: 55a65211-b1c9-9b0b-e063-6294a90a5cfb
spl set id: 55a2f4da-bb1e-8ead-e063-6394a90af72e

Reported adverse events (FAERS/openFDA)#

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