EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]

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EYE WASH (WATER) SOLUTION [MAJOR PHARMACEUTICALS]
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NDC 0904-5377-20
Set ID 2c3a31d8-e6ca-4a68-86e9-25993cd934ad
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredient

    Purified water (99.05%)

  • Purpose

    Eyewash

  • Uses

    washes the eye to help relieve

    •
    irritation
    •
    stinging
    •
    itching;

    by removing

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

  • 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
  • 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%.

  • Questions?

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

    6782803

    CT07025

    DISTRIBUTED BY

    MAJOR PHARMACEUTICALS

    31778 ENTERPRISE DRIVE

    LIVONIA, MI 48150 USA

    ©Major Pharmaceuticals

    Rev. 11/10

    Re-Order No. 700194

  • Package/Label Principal Display Panel

    Major Eye Wash Carton

    NDC 0904-5377-20

    MAJOR®

    EYE

    WASH

    •
    Cleanses
    •
    Refreshes
    •
    Soothes

    4 FL OZ (118 mL)

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-5377
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-5377-201 in 1 CARTON08/31/201009/26/2021
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/31/201009/26/2021
    Labeler - Major Pharmaceuticals (191427277)
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