Label: EYE WASH- 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 November 2, 2017

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  • INDICATIONS & USAGE

    Uses:

    fOR CLEANSING THE EYE TO HELP RELIEVE IRRITATION OR BURNING BY REMOVING LOOSE FOREIGN MATERIAL

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health

    professional before use.

  • 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.

  • WARNINGS

    Warnings:

    For external use only. 

    Do not use if: you experience any open wounds in or near the eye and obtain immediate medical treatment. 

    If solution changes color or becomes cloudy.

    When using this product -To avoid contamination, do not touch tip of container to any surface.  Do not reuse.  Once opened, discard

    Stop use and ask a doctor if you have any of the following:  Changes in vision.  Eye pain.  Condition worsens or persists.  Continued redness or irritation of the eye.

  • DOSAGE & ADMINISTRATION

    Directions:

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

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    sodium chloride

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT-PURIFIED WATER 98.3%

  • PURPOSE

    EYEWASH

  • PRINCIPAL DISPLAY PANEL

    Provision 8 ounce bottle

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    purified water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2180
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER983 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69103-2180-8236 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2015
    2NDC:69103-2180-7118 mL in 1 BOTTLE; Type 0: Not a Combination Product07/23/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/23/2015
    Labeler - Provision Medical Products (036936831)
    Registrant - Provision Medical Products (036936831)
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