Label: SPERIAN EYESALINE EYEWASH- water liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 7, 2011

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  • Active ingredient

    Water 99.8%

  • Purpose

    Emergency eyewash

  • Uses

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

    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.

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

  • Directions

    • remove contacts before using
    • twist top to remove
    • flush the affected eye 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 information

    • store at room temperature, 15o to 30o C (59o to 86o F)
    • do not freeze
  • Inactive ingredients

    sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic
  • Questions?

    1-800 - 430-5490

    Sperian Eye and Face Protection, Inc.
    (a Honeywell Company)
    825 East Highway 151
    Platteville, WI 53818 USA
  • Principal Display Panel

    image of PDP

  • INGREDIENTS AND APPEARANCE
    SPERIAN EYESALINE EYEWASH 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem 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:64809-101-1230 mL in 1 BOTTLE, PLASTIC
    2NDC:64809-101-13118 mL in 1 BOTTLE, PLASTIC
    3NDC:64809-101-14237 mL in 1 BOTTLE, PLASTIC
    4NDC:64809-101-15473 mL in 1 BOTTLE, PLASTIC
    5NDC:64809-101-16946 mL in 1 BOTTLE, PLASTIC
    6NDC:64809-101-2115 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/07/2011
    Labeler - Sperian Eye & Face Protection Inc (013435034)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sperian Eye & Face Protection Inc013435034manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Medex Cardio Pulmonary dba Smiths Medical835634168manufacture
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