Label: EYEWASH- purified 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 January 9, 2018

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  • Drug Facts

  • Active ingredient

    Purified Water 99.1 %

  • Purpose

    Eyewash

  • Uses

    For cleansing the eye to remove loose foreign material.

  • Warnings

    For external use only.

    Do not use • if solution changes colour or becomes cloudy • for injection • as a contact lens solution.

    When using the product • do not re-use, once opened, discard. • to avoid contamination, do not touch the tip of the container to any surface.

    Stop use and consult a doctor if • you experience eye pain. • changes in vision. • continued redness or irritation of the eye. • the
    condition worsens or persists.

    Obtain immediate medical treatment for all open wounds in or near the eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. • If swallowed, get medical help or contact a Poison Control Centre right away.

  • Directions

    • smoothly twist the lid in either direction to break the seal and remove the lid. • position the bottle above the eye and gently squeeze.
    • flush the affected eye as needed controlling the rate of flow of solution by pressure on the bottle. • cleanse the eye(s) with as much solution as required.

  • Other information

    • store between 5°C and 35°C (41° to 95° F). • use before expiry date. • do not use if seal is broken prior to use.

  • Inactive ingredient

    Sodium Chloride.

  • Questions?

    Call 1-844-405-7233. Monday - Friday, 9am - 5pm. You may also report serious side effects to this number.

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:

    Reliance Medical LTD, Radnor Park Trading

    Estate, Congleton, Cheshire, England, CW12 4XP.

    IMPORTED AND DISTRIBUTED BY:

    Innovative Safety Supply USA Inc. 5150 West 76th St. Indianapolis,

    IN, 46268 USA.

    MADE IN CHINA

    Compliance:

    ANSI/ISEA Z358.1-2014

    (As Personal Eye Wash Only)

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    EYEWASH 
    purified water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71271-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.991 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71271-100-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/03/2017
    Labeler - Reliance Medical Ltd (349044854)
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