FENDALL 2000 PURE FLOW- purified water liquid

United States - English - NLM (National Library of Medicine)

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Active ingredient:
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)
Available from:
Honeywell Safety Products USA, Inc.
Administration route:
OPHTHALMIC
Prescription type:
OTC DRUG
Therapeutic indications:
Emergency Eyewash For flushing or irrigating the eye to reduce chances of severe injury caused by acid, alkali, or particulate contamination
Authorization status:
OTC monograph final
Authorization number:
0498-0631-37

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FENDALL 2000 PURE FLOW- purified water liquid

Honeywell Safety Products USA, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Fendall 2000 Pure flow

Active ingredient

Purified Water 98.6%

Purpos e

Emergency Eyewash

Us es

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

particulate contamination

Warnings

For external use only

store at room temperature, 59

to 86

F (15

to 30

do not freeze

Do not use

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

changes in vision

eye pain

continued redness, irritation of the eye or if the condition worsens or persists

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

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

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

monobasic

monobasic

Ques tions ?

Call 1-800-430-5490

Sperian Eye & Face Protecton, Inc.

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA

Principle Display Panel

FENDALL 2000 PURE FLOW

purified water liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 49 8 -0 6 31

Route of Administration

OPHTHALMIC

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R) (WATER - UNII:0 59 QF0 KO0 R)

WATER

9 8 .6 L in 10 0 L

Inactive Ingredients

Ingredient Name

Stre ng th

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

SO DIUM PHO SPHATE, MO NO BASIC, MO NO HYDRATE (UNII: 59 3YOG76 RN)

SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74)

Packag ing

Honeywell Safety Products USA, Inc.

#

Item Code

Package Description

Marketing Start

Date

Marketing End Date

1

NDC:0 49 8 -0 6 31-

29 .9 L in 1 CONTAINER; Type 0 : No t a Co mbinatio n

Pro duc t

12/0 1/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt349

12/15/20 18

Labeler -

Honeywell Safety Products USA, Inc. (079287321)

Registrant -

Honeywell Safety Products USA, Inc. (079287321)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Spe ria n

0 134350 34

ma nufa c ture (0 49 8 -0 6 31)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Ho neywell Safety Pro ducts USA, Inc.

16 7518 6 17

pa c k(0 49 8 -0 6 31)

Revised: 12/2020

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