Label: PRINZING EYE WASH STATION- kit

  • Category: MEDICAL DEVICE
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated June 24, 2014

If you are a consumer or patient please visit this version.

  • 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)

    Eyewash Station Label

  • 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.)

    Sperian Bottle Label

  • INGREDIENTS AND APPEARANCE
    PRINZING EYE WASH STATION 
    first aid kit with drug kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:55925-100
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:55925-100-021 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 946 mL
    Part 1 of 1
    SPERIAN EYESALINE EYEWASH 
    water liquid
    Product Information
    Item Code (Source)NDC:64809-101
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.8 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64809-101-161892 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/07/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceABC07/02/2013
    Labeler - BRADY MEXICO, S. DE R.L. DE C.V. (812761655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sperian Eye & Face Protection Inc013435034manufacture, label