FDA Label for Sperian Eyesaline Eyewash

View Indications, Usage & Precautions

Sperian Eyesaline Eyewash Product Label

The following document was submitted to the FDA by the labeler of this product Sperian Eye & Face Protection Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Package Label.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)

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.)


Otc - Active Ingredient



Active Ingredient:

Sterile water 99.8%


Otc - 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


Otc - Do Not Use



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

Otc - When Using



When using this product

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

Otc - Stop Use



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

Otc - 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


Otc - Questions



Questions?1-800-430-5490

Sperian Eye & Face Protection, Inc.

(a Honeywell Company)

825 East Highway 151

Platteville, WI 53818 USA


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