Label: EYE WASH- water solution 

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/10

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

  • Active ingredient

    Purified water (99.05%)

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  • Purpose

    Eyewash

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  • Uses

    washes the eye to help relieve

    • irritation
    • stinging
    • itching;

    by removing

    • loose foreign material
    • air pollutants (smog or pollen)
    • chlorinated water
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  • Warnings

    Do not use

    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
    • you have open wounds in or near the eye

    Keep out of reach of children.

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

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  • Directions

    • flush the affected eye(s) as needed
    • control the rate of flow of solution by pressure on the bottle

    When using an eye cup

    • rinse the cup with clean water immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
    • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash or lotion
    • rinse the cup with clean water after each use

    Other information

    • store at 15º–30ºC (59º–86ºF)
    • keep tightly closed
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  • Inactive ingredients

    Boric acid, sodium borate and sodium chloride. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: edetate disodium 0.025% and sorbic acid 0.1%.

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  • Questions?

    Serious side effects associated with use of this product may be reported to: 1-800-323-0000

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  • Package/Label Principal Display Panel

    Major Carton Eye Wash

    NDC 0904-5377-20

    Major

    EYE WASH

    Cleanses Refreshes Soothes

    4 FL OZ (118 mL)

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  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    water solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0904-5377
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    WATER (WATER) WATER 99.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    BORIC ACID  
    SODIUM BORATE  
    SODIUM CHLORIDE  
    HYDROCHLORIC ACID  
    SODIUM HYDROXIDE  
    EDETATE DISODIUM  
    SORBIC ACID  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0904-5377-20 1 in 1 CARTON
    1 118 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 08/31/2010
    Labeler - Major Pharmaceuticals (191427277)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 114406598 MANUFACTURE
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