Label: PLUM DUO EMERGENCY EYEWASH PH NEUTRALIZING- water liquid

  • 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 20, 2015

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  • Active ingredient

    Purified water 95.1%

  • Purpose

    Emergency eyewash and skin flush

  • Uses

    For flushing the eye and skin to reduce chances of severe injury caused by acid, alkali, or particulate contamination.

  • Warnings

    For external use only
  • Do not use

    ● for injection  ● in intraocular surgery  ● internally
    ● If solution changes color or becomes cloudy

  • When using this product

    ● avoid contamination  ● do not reuse

    Once opened, discard.

  • Ask a doctor if you have

    ● eye pain  ● changes in vision

    ● redness or irritation of the eye after use  ● an injury caused by alkali

  • Keep out of reach of children

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

  • Directions

    ● do not dilute solution or reuse bottle

    ● to open, twist cap in the direction of the arrow

    ● center the DUO between the eyes to simultaneously wash both eyes

    ● control flow of solution by pressure on bottle   ● flush affected area as needed

    ● continue to flush with water as necessary   ● obtain medical treatment

  • Other information


    ● not for use as a contact lens solution  ● twist cap to open

    ● use before expiration date marked on bottle

    ● store at room temperature 5° to 35° C (41° to 95°F)

  • Inactive ingredients

    Sodium phosphate dibasic, Monopotassium phosphate

  • QUESTIONS

    Questions or Comments?  Call toll-free number 1-800-423-5278

  • Distributed by

    Bel-Art Products  ● 661 Route 23 South  ● Wayne, NJ 07470

  • PRINCIPAL DISPLAY PANEL

    Plum

    EMERGENCY EYEWASH

    pH NEUTRALIZING

    NDC 67691-201-22

    DUO

    STERILE

    500 ml (16.9 fl oz)

    Bel-Art Products
    661 Route 23 South, New Jersey, 07470
    Tel: 973-694-0500  Fax: 973-694-7199  www.belart.com

    Compliance: ANSI/ISEA Z358.1-2009
    (As a Personal Eyewash Only)

    Duo pH Neutralizer Label r1.jpg

    Duo pH Neutralizer Label r1

    Duo pH Neutralizer Label r1.jpg

  • INGREDIENTS AND APPEARANCE
    PLUM DUO EMERGENCY EYEWASH PH NEUTRALIZING 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67691-201
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water95.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Phosphate, Dibasic (UNII: GR686LBA74)  
    Potassium Phosphate, Monobasic (UNII: 4J9FJ0HL51)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67691-201-22500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/23/2010
    Labeler - Bel-Art Products (002176733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plum A/S305299489manufacture(67691-201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holopack Verpackungstechnik GmbH343390324Manufacture(67691-201)
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