WATER ADDITIVE (PURIFIED WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]

WATER ADDITIVE (PURIFIED WATER) LIQUID [SPERIAN EYE & FACE PROTECTION INC]
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NDC 64809-105-20
Set ID eff94695-403e-4669-9bd1-f2cb05ec9b31
Category HUMAN OTC DRUG LABEL
Packager Sperian Eye & Face Protection Inc
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredient

    Purified water

  • Purpose

    Flushing Agent

  • Uses

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

  • Warnings

    • For external use only
    • To avoid contamination do not touch tip of container to any surface

    Do not use

    • in concentrated form
    • while wearing contact lenses
    • if solution changes color or becomes cloudy
    • for injection
    • in intraocular surgery
    • internally

    Ask a doctor if you have

    • eye pain
    • changes in vision
    • redness or irritation of eye after use
    • an injury caused by an alkali

    Keep out of reach of children

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

  • Directions

    Mix additive with potable water as follows:

    • Wear protective eyewear and gloves
    • Follow sanitary procedures
    • Thoroughly clean portable eyewash station and rinse with potable water
    • Use a clean container of sufficient capacity to mix enough solution to fill eyewash station. Solution may be mixed directly in eyewash station
    • Add entire contents of the bottle to the container
    • Fill the station to the manufacturer's required level and mix or agitate thoroughly
    • Date station inspection
    • Station should be cleaned and refilled every 120 days when using this product
    • Properly dispose of empty bottles after use. D o not reuse.
  • Other information

    • Do not use is seal is broken
    • Do not freeze
    • Do not use if eye is lacerated or object is embedded
    • For use in emergency eyewash stations only
    • Mix per directions
    • Sperian Water Additive must not be used undiluted or in solution for any other purpose
    • Do NOT add any other chemicals or materials to this solution
    • Avoid contact with skin
    • Store between 35 oF - 100 oF (2 oC - 38 oC)
  • Inactive ingredients

    chlorhexidine digluconate

  • Questions?

    Call 1-800-336-3255

    Sperian Eye & Face Protection, Inc.

    825 East Highway 151

    Plattville, WI 53818 USA

  • Principal Display Panel

    image of pdp
  • INGREDIENTS AND APPEARANCE
    WATER ADDITIVE 
    purified water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64809-105
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64809-105-20236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/01/2012
    Labeler - Sperian Eye & Face Protection Inc (013435034)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sperian Eye & Face Protection Inc013435034manufacture(64809-105)

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