RUGBY EYE WASH (WATER, PURIFIED) LIQUID [RUGBY LABORATORIES]

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RUGBY EYE WASH (WATER, PURIFIED) LIQUID [RUGBY LABORATORIES]
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NDC 0536-1224-97
Set ID 1fee974b-4c29-4965-bd3d-da5e219eb13a
Category HUMAN OTC DRUG LABEL
Packager Rugby Laboratories
Generic Name
Product Class
Product Number
Application Number PART349
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  • Active ingredients

    Purified water (99.05%)

  • Purpose

    Eyewash

  • Uses

    washes the eye to help relieve

    • irritation
    • discomfort
    • burning
    • stinging
    • itching

    by removing

    • 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 the tip of container to any surface to avoid contamination
    • replace cap after each 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 (1-800-222-1222) 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 Solution 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 15°-25°C (59°-77°F)
    • 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?

    Toll free product Information or to report a Serious Side Effect Associated with use of this product Call: 1-800-645-2158

  • Rugby Eye Wash Eye Irrigating Solution 4fl oz

    Rugby Eye Wash Eye Irrigating Solution 4fl oz

  • INGREDIENTS AND APPEARANCE
    RUGBY EYE WASH 
    water, purified liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1224
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 g  in 100 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:0536-1224-971 in 1 BOX02/22/2019
    1118 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/22/2019
    Labeler - Rugby Laboratories (079246066)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bausch & Lomb Incorporated114406598manufacture(0536-1224)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals174450460pack(0536-1224) , label(0536-1224)
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