Label: SPERIAN EYESALINE EMERGENCY EYEWASH- purified 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 March 21, 2018

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  • Active ingredient

    Purified Water 98.6%

  • 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- Obtain immediate medical treatment for all open wounds in or near eyes. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

    Do not use

    • if solution changes color or gets cloudy
    • with contact lenses
    • if seal is broken or tampered with
    • if the eye is lacerated or object is embedded

    Stop use and ask 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
    • flush the affected area as needed
    • if necessary, continue flushing with emergency eyewash or shower

  • Other information

    • store at room temperature, 59 o to 86 oF (15 o to 30 oC)
    • do not freeze
  • Inactive Ingredients

    benzalkonium chloride, edatate disodium, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic

  • Questions?

    Call 1-800-430-5490

    Sperian Eye & Face Protection, Inc.

    (a Honeywell Company)

    825 East Highway 151

    Platteville, WI 53818 USA

  • Package label

    Emergency eyewash

  • INGREDIENTS AND APPEARANCE
    SPERIAN EYESALINE EMERGENCY EYEWASH 
    purified water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64809-100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64809-100-1014384 mL in 1 BAG; Type 0: Not a Combination Product09/06/2011
    2NDC:64809-100-113785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/06/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34909/06/2011
    Labeler - Sperian Eye & Face Protection Inc (013435034)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sperian Eye & Face Protection Inc013435034manufacture(64809-100)
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