Label: EYE WASH- 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 January 7, 2021

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

  • Drug Facts

  • ​Active ingredient

    Purified Water 99.1%

    ​Purpose

    Eyewash

  • ​Use

    • For cleansing the eye to help relieve irritaion or burning by removing loose foreign material
  • ​Warnings

    ​For external use only.

    Do not use

    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
    • obtain immediate medical treatment for all open wounds in or near the eyes

    Stop use and ask a doctor if

    you experience:

    • eye pain
    • changes in vision
    • continued redness
    • irritation of the eye
    • condition worsens or perisists

    Keep out of reach of children.

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

  • ​Directions

    • Flush the affected eyes as needed, controlling the rate of flow of solution by pressure on the bottle
  • ​Other information

    • not for use as contact len solution
    • use before expiration date marked on the bottle
    • store at room temperature, 5 ​o​ to 35 ​o​C (41 ​o​ to 95 ​o​F)
  • ​Inactive ingredients

    Benzalkonium chloride, sodium chloride

  • Package Labeling:

    Eye wash

  • INGREDIENTS AND APPEARANCE
    EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49687-0010
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER991 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49687-0010-11 in 1 BOX08/09/2016
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34908/09/2016
    Labeler - CMC Group Inc. (117201448)