Label: REXALL STERILE EYE WASH- eye wash solution

  • 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 June 10, 2020

If you are a consumer or patient please visit this version.

  • Active ingredient

    Purified water (99.05%)

  • Purpose

    Eyewash

  • Uses

    washes the eye to help relieve

    irritation
    discomfort
    burning
    stinging
    itching
    loose foreign material
    air pollutants (smog or pollen)
    chlorinated water
  • Warnings

    For external use only

    Do Not Use

    if you have open wounds in or near the eyes, and get medical help right away
    if solution changes color or becomes cloudy

    When using this product

    remove contact lenses before using
    do not touch tip of container to any surface to avoid contamination
    replace cap after use

    Stop use and ask a doctor if

    you experience eye pain, changes in vision, continued redness or irritation of the eye
    condition worsens or persists

    Keep out of reach of children

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

  • Directions

    For use with nozzle applicator.

    flush the affected eye(s) as needed
    control the rate of flow of solution by pressure on the bottle
    do not touch dropper tip to eye

    When using an eye cup

    rinse the cup with Eye Wash immediately before each use
    avoid contamination of the rim and inside surfaces of the cup
    fill the cup half full with Eye Wash Solution and apply the cup to the affected eye(s), pressing tightly to prevent spillage
    tilt the head backward. Open eyelids wide and rotate eyeball to thoroughly wash the eye
    rinse cup with clean water after each use
    replace cap after use
  • Other information

    store at 15o-25oC (59o -77oF)
    keep tightly closed
    does not contain thimerosal
    enclosed eyecup is sterile if packaging is intact
    use before expiration date marked on the carton or bottle.
  • Inactive ingredients

    boric acid, sodium borate and sodium chloride.

    PRESERVATIVE ADDED: benzalkonium chloride (0.01%)

  • Questions or comments?

    Call: 1-866-4-REXALL

  • Principal Display Panel - carton

    Since 1903

    Rexall™

    Sterile

    Eye

    Wash

    Eye Irrigating

    Solution

    Cleanses
    Refreshes
    Soothes
    For daily or emergency eye cleansing

    Sterile Eye Cup Included

    4 FL OZ (118 mL)

    carton.jpg
  • INGREDIENTS AND APPEARANCE
    REXALL STERILE EYE WASH 
    eye wash solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-577
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER.9905 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-577-041 in 1 CARTON01/01/2013
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/2013
    Labeler - Dolgencorp Inc (068331990)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598MANUFACTURE(55910-577)