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
* Please review the disclaimer below.