EYE CLEAN (EYE WASH) LIQUID [HART HEALTH]

EYE CLEAN (EYE WASH) LIQUID [HART HEALTH]
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NDC 50332-0201-1, 50332-0201-3, 50332-0201-4, 50332-0201-6, 50332-0201-8
Set ID 41f53e2e-c2bc-4bf1-a541-3bcb2cf63002
Category HUMAN OTC DRUG LABEL
Packager HART Health
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active Ingredient: Purified Water 98.3%

  • PURPOSE

    Purpose: Eyewash

  • INDICATIONS & USAGE

    Use: For cleansing the eye to help relieve irritation or burning by removing loose foreign material

  • WARNINGS

    Warnings: For external use only

  • DO NOT USE

    Do not use:

    • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
    • if solution changes color or becomes cloudy
  • WHEN USING

    When using this product:

    • to avoid contamination, do not touch tip of container to any surface
    • do not reuse
    • once opened, discard
  • STOP USE

    Stop use and ask a doctor if you experience:

    • changes in vision
    • eye pain
    • condition worsens or persists
    • continued redness or irration of the eye
  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions: Flush the affeced eye as needed, controlling the rate of flow of solution by pressure on the bottle.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Boric Acid, Sodium Borate, Sodium Chloride

  • PRINCIPAL DISPLAY PANEL

    EyeClean.jpg

    EyeClean.jpg

  • INGREDIENTS AND APPEARANCE
    EYE CLEAN 
    eye wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0201
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER98.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0201-330 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1900
    2NDC:50332-0201-1118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1900
    3NDC:50332-0201-4236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1900
    4NDC:50332-0201-6473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1900
    5NDC:50332-0201-8946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/1900
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/01/1900
    Labeler - HART Health (069560969)
    Registrant - Niagara Pharmaceuticals, Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc.205477792manufacture(50332-0201)

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