Label: EYES ALIVE 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 December 7, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Purified Water 98%

  • Purpose

    Emergency eye wash and skin flush

  • Indications

    For flushing the eye to help relieve irritation, discomfort, burning, stinging, smarting or itching by removing loose foreign material, air pollutants (smog or pollen) or chlorinated water.

  • Warnings

    For external use only

    • To avoid contamination, do not touch tip of bottle to any surface
    • Do not reuse
    • Once opened, discard

    Do not use

    If solution changes colors or becomes cloudy

    • With contact lenses
    • If bottle is opened or seal is broken

    Stop use and consult a doctor if you experience

    Eye pain

    • Changes in vision
    • Continued redness or irritation of the eye or if the condition worsen or persists.

    Obtain immediate medical treatment for all open wounds in or near the eyes.

    Keep out of reach of children

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

  • Directions

    To pour-hold bottle securely, twist off top to remove

    • Control rate of flow by pressure on the bottle
    • Flush the affected eye as needed
    • Do not touch bottle tip to eye.
  • Other Information

    Tamper-evident cap: Do not use if twist off top is broken or missing

    • Twist cap to open
    • Use before expiration date marked on bottle
    • Store at room temperature, 15°-30° C (59° to 86°F).
  • Inactive Ingredients

    Benzalkonium chloride, edetate disodium dihydrate, sodium chloride, sodium phosphate dibasic heptahydrate, sodium phosphate monobasic monohydrate.

  • Questions or Comments?

    Call 800.477.2884, M-F 9 am-5 pm Eastern time

  • PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

    EMERGENCY
    EYE WASH

    Eyes
    Alive™

    Eye Wash
    Sterile Buffered Isotonic Saline Solution

    Single Use

    Item # D5L-235
    Mfd. for Division5 Labs, Inc.
    7555 West 2nd Court
    Miami, FL 33014
    www.division5labs.com

    32 fl.oz. (946 mL)

    MADE IN
    THE USA

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    EYES ALIVE EYE WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69183-230
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water980 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium chloride (UNII: F5UM2KM3W7)  
    edetate disodium (UNII: 7FLD91C86K)  
    sodium chloride (UNII: 451W47IQ8X)  
    sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)  
    sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69183-230-32946 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    2NDC:69183-230-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    3NDC:69183-230-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2017
    4NDC:69183-230-202 in 1 CARTON02/01/2017
    4NDC:69183-230-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:69183-230-404 in 1 CARTON02/01/2017
    5NDC:69183-230-0015 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34902/01/2017
    Labeler - DIVISION 5 LABS, INC. (968198288)
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