Label: EYE WASH- purified water solution

  • 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 February 18, 2020

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

  • Active ingredient

    Purified water (99.05%)

  • Purpose

    Eyewash

  • Uses

    washes the eye to help relieve

    • irritation
    • stinging
    • discomfort
    • itching

    by removing

    • loose foreign material
    • air pollutants (smog or pollen)
    • chlorinated water
  • Warnings

    For external use only

    Do not use

    • if solution changes color or becomes cloudy

    When using this product

    • remove contact lenses before using
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after use

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists
    • you have open wounds in or near the eye. Get medical help right away.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • flush the affected eye(s) as needed
    • control the rate of flow of solution by placing pressure on the bottle

    When using an eye cup

    • rinse the cup with Eye Wash immediately before each use
    • avoid contamination of the rim and inside surfaces of the cup
    • fill the cup half full with Eye Wash and apply the cup to the affected eye(s), pressing tightly to prevent the escape of the liquid
    • tilt the head backward. Open eyelids wide and rotate eyeball to ensure thorough bathing with the wash.
    • rinse the cup with clean water after each use
  • Other information

    • store at room temperature 15° - 25°C (59° - 77°F)
    • keep tightly closed
  • Inactive ingredients

    boric acid, sodium borate, sodium chloride, hydrochloric acid PRESERVATIVE ADDED: edetate disodium, polyhexamethylene biguanide

  • Question or comments?

    call 1-800-616-2471

  • HOW SUPPLIED

    Product: 50090-3159

    NDC: 50090-3159-0 118 mL in a BOTTLE / 1 in a BOX

  • purified water

    Label Image
  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    purified water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-3159(NDC:0904-6633)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER99.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-3159-01 in 1 BOX10/10/2017
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34905/01/2017
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-3159)