PRINZING EYE WASH STATION- kit

Prinzing Eye Wash Station by

Drug Labeling and Warnings

Prinzing Eye Wash Station by is a Other medication manufactured, distributed, or labeled by BRADY MEXICO, S. DE R.L. DE C.V., Sperian Eye & Face Protection Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

PRINZING Part #DSP EW1

PRINZING

Part #DSP EW1

THIS BOX CONTAINS

NO.                      DESCRIPTION                                                          COUNTRY OF ORIGIN        QTY.

Y235674            32 OZ. BOTTLE EYESALINE REFILL                          USA                                        2

Y382769            POLY BAGS 16X20 2 MIL                                         CHINA                                     1

Y389397            PRINZING EYE WASH DISPENSER UNBOXED        MEXICO                                   1

Y526795            INSERT A FOR Y391541                                          USA                                         2

Y526796            INSERT B FOR Y391541                                          USA                                         2

Y526794            CARTON BOX (CAJA) FOR Y391541                       USA                                         1

Y395186            PKG LABEL .B424 3.0"X2.9", MEX/GH                  MEXICO                                   1

Y34465              THT-25-424-1                                                         MEXICO                                   2

WO: 23128444

*Y384842*

BRADY MEXICO S DE RL DE CV

Guerrero Negro No. 2, NORDIKA,

Tijuana, Baja California,

Mexico, C.P. 22644

PACKAGED IN MEXICO

PRINZING

PRODUCT: Prinzing Eyewash Station Equipped

MANUFACTURED BY: BRADY MEXICO S DE RL DE CV

Guerrero Negro No. 2, NORDIKA,

Tijuana, Baja California, Mexico, C.P. 22644

CONTENT: One Eye Wash Station

DIRECTIONS FOR USE

Purposes: emergency eyewash and skin flush.

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

Directions for use: - twist cap open - do not dilute solution or reuse bottle - hold container a few inches above the eye or skin - control flow of solution by pressure on bottle - flush affected area as needed a minimum of 20 minutes

Warnings: for external use only

Do not use: - for injection - intraocular surgery - if solution changes color or becomes cloudy

When using this product: - avoid contamination, do not touch tip of container to any surface - do not reuse - once opened, discard - obtain immediate medical treatment for all open wounds in or near the eyes

Ask doctor if you have: - eye pain - changes in vision - redness or irritation of the eye after use - an injury cause by alkali - condition worsens or persists

Keep out of reach of children - If swallowed, get medical help or contact a poision control center right away

Other information: - tamper evident: do not use if twist off top is broken or missing - not for use as a contact lens solution - use before expiration date marked on bottle - store at room temperature 15 degrees Celcius to 30 degrees Celcius (59 degrees - 86 degrees Fahrenheit)

ACTIVE INGREDIENT

Active Ingredient:

Sterile water 99.8%

PURPOSE

Purpose:

Emergency eyewash

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings:     For external use only

Do not use

• if solution changes color or gets cloudy
• with contact lenses
• if twist-off top is broken or missing
• in open wounds in or near the eyes

When using this product

• avoid contamination, do not touch tip of container to any surface

Stop use and consult a doctor if you have

• changes in vision
• eye pain
• continued redness or irritation of the eye, or if the condition worsens or persists

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• remove contacts before using
• twist top to remove
• flush the affected area as needed, controlling the rate of flow of the solution by pressure on the bottle
• if necessary, continue flushing with emergency eyewash or shower
• do not reuse
• once opened, discard
• obtain medical treatment

OTHER SAFETY INFORMATION

Other information

• store at room temperature, 15 degrees to 30 degrees Celsius (59 degrees to 86 degrees Fahrenheit)
• do not freeze

INACTIVE INGREDIENT

Inactive ingredients

sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

QUESTIONS

Questions?1-800-430-5490

Sperian Eye & Face Protection, Inc.

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA

PRINCIPAL DISPLAY PANEL

TAMPER-EVIDENT CAP. DO NOT USE IF TWIST-OFF TOP IS BROKEN OR MISSING

SPERIAN

eyesaline

Eyewash

Sterile Isotonic Solution

32 fl. oz. (946 ml.)

INGREDIENTS AND APPEARANCE

PRINZING EYE WASH STATION 
first aid kit with drug kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:55925-100

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:55925-100-02	1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, PLASTIC	946 mL

Part 1 of 1

SPERIAN EYESALINE EYEWASH 
water liquid

Product Information
Item Code (Source)	NDC: 64809-101
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R)	WATER	99.8 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64809-101-16	1892 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	09/07/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	ABC	07/02/2013

Labeler - BRADY MEXICO, S. DE R.L. DE C.V. (812761655)

Establishment
Name	Address	ID/FEI	Business Operations
Sperian Eye & Face Protection Inc		013435034	manufacture, label