EYEWASH (WATER) SOLUTION [AKORN ANIMAL HEALTH, INC.]

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EYEWASH (WATER) SOLUTION [AKORN ANIMAL HEALTH, INC.]
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NDC 59399-001-04, 59399-001-08
Set ID 6dc20e8a-cf22-43fd-af73-034e5e045b42
Category OTC ANIMAL DRUG LABEL
Packager Akorn Animal Health, Inc.
Generic Name
Product Class
Product Number
Application Number NDA022305
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  • 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)
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