Label: BUFFERED EYE-LERT- 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 July 13, 2010

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  • Active ingredient

    Purified water 98%

  • Purpose

    Emergency eyewash and skin flush

  • Uses

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

  • Warnings

    For external use only

    Do not use

    • for injection
    • in intraocular surgery
    • internally
    • 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 caused by an alkai
    • condition worsens or persists

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

  • Directions

    • 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

  • Other information

    • tamper evident: do not use if twist off top is broken or missing
    • not for use as a contact lens solution
    • twist cap to open
    • use before expiration date marked on bottle
    • store at room temperature, 15o to 30oC  (59o to 86o)
  • Inactive ingredients

    benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate

  • Questions

    Questions or comments?  Call toll free number 1-800-130-4110

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    BUFFERED EYE-LERT 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-0160
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0498-0160-16473 mL in 1 BOTTLE, PLASTIC
    2NDC:0498-0160-38946 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/06/2010
    Labeler - North Safety Products (059980441)
    Registrant - North Safety Products (059980441)
    Establishment
    NameAddressID/FEIBusiness Operations
    North Safety Products 059980441manufacture
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