Label: EYE CLEAN- eye wash liquid

  • NDC Code(s): 50332-0201-1, 50332-0201-3, 50332-0201-4, 50332-0201-6, view more
    50332-0201-8
  • Packager: HART Health
  • 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 November 5, 2019

If you are a consumer or patient please visit this version.

  • 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)