Label: PLUM EMERGENCY EYEWASH- 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

    Active Ingredient

    Purified water 99.1%

  • PURPOSE

    Purpose

    Emergency eyewash and skin flush

  • INDICATIONS & USAGE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use • for injection • in intraocular surgery • internally
    • if solution changes color or becomes cloudy.

  • WHEN USING

    When using this product • avoid contamination, do not touch tip of container to any surface
    • do not reuse. Once opened, discard.

  • ASK DOCTOR

    Ask 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

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

  • DOSAGE & ADMINISTRATION

    Directions • do not dilute solution or reuse bottle
    • hold container a few inches above the eye or skin
    • control flow of solution by pressure on bottle • flush affected area as needed
    • continue to flush with water if necessary • obtain medical treatment

  • GENERAL PRECAUTIONS

    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 INGREDIENT

    Inactive Ingredients sterile sodium chloride

  • QUESTIONS

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

  • PRINCIPAL DISPLAY PANEL

    Plum
    EMERGENCY EYEWASH
    NDC 67691-100-02

    STERILE

    200 ml (6.76 fl oz)

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

    Compliance: ANSI Z358.1-2004 (As Personal Eye Wash Only)


    Plum Eyewash Saline Label.jpg
    Plum Eyewash Saline Label
    Plum Eyewash Saline Label.jpg

  • INGREDIENTS AND APPEARANCE
    PLUM EMERGENCY EYEWASH 
    water liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67691-100
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water99.1 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67691-100-02200 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67691-100-101000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:67691-100-05500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/08/2008
    Labeler - Bel-Art Products (002176733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Plum Kemi Produktion A/S305299489manufacture(67691-100)
    Establishment
    NameAddressID/FEIBusiness Operations
    Holopack Verpackungstechnik GmbH343390324manufacture(67691-100)
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