EYEWASH (PURIFIED WATER) LIQUID [RELIANCE MEDICAL LTD]

EYEWASH (PURIFIED WATER) LIQUID [RELIANCE MEDICAL LTD]
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NDC 71271-100-01, 71271-100-02
Set ID 41dee46f-008d-43b3-b1a6-f161e2d2a2cd
Category HUMAN OTC DRUG LABEL
Packager Reliance Medical Ltd
Generic Name
Product Class
Product Number
Application Number PART349
  • 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 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, UK.

    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:71271-100-0125 in 1 CARTON07/03/2017
    120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:71271-100-02250 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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