Label: EYEWASH- water solution

  • NDC Code(s): 59399-001-04, 59399-001-08
  • Packager: Akorn Animal Health, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 8, 2020

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Purified water 98.3%

  • Purpose

    Eyewash

  • Use

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

  • Warnings

    For external use only

    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 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 experience

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

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

  • Directions

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

  • Other information

    • lot number is printed on the bottle
    • store at 20° to 25° C [68° to 77° F]
    • for your protection, this bottle has an imprinted white seal with black printing “TAMPER EVIDENT SEAL”
    • do not use if this seal is missing or broken
    • use before expiration date marked on bottle
  • Inactive ingredients

    boric acid, sodium borate, sodium chloride

  • Questions ?

    Call 888-628-0581

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    Akorn Animal Health logo

    OPHTHALMIC

    SOLUTION

    EYEWASH

    Purified Water, 98.3%

    NDC 59399-001-04

    Single Use

    Distributed by:

    Akorn, Inc.

    Lake Forest, IL

    60045

    EVAAL Rev. 06/15

    Made in

    Canada

    Sterile

    Solution

    4 fl.oz. (118 mL)

    Principal Display Panel Text for Container Label
  • INGREDIENTS AND APPEARANCE
    EYEWASH 
    water solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:59399-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water929 g  in 946 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:59399-001-041 in 1 BOTTLE
    1118 mL in 1 BOTTLE
    2NDC:59399-001-081 in 1 BOTTLE
    2236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/01/2015
    Labeler - Akorn Animal Health, Inc. (117696748)
    Registrant - Akorn Operating Company LLC (117693100)