Label: PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH- purified water 98.3% solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated November 1, 2019

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  • ACTIVE INGREDIENT

    Active Ingredients

    Purified Water 98.3%

  • PURPOSE

    Purpose

    Eyewash

  • INDICATIONS & USAGE


    Use

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

  • WARNINGS

    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

     

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

  • DOSAGE & ADMINISTRATION

     

    Directions

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

  • INFORMATION FOR PATIENTS

     

    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 INGREDIENT

     

    Inactive ingredients

    boric acid, sodium borate, sodium chloride

  • QUESTIONS

    Questions?  Call   1-800-835-2263

  • PRINCIPAL DISPLAY PANEL

    image descriptionMM1

  • INGREDIENTS AND APPEARANCE
    PHYSICIANSCARE OPHTHALMIC SOLUTION EYEWASH 
    purified water 98.3% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0160(NDC:65785-160)
    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:0924-0160-0130 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product06/12/2013
    2NDC:0924-0160-04118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product06/12/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230506/12/2013
    Labeler - Acme United Corporation (001180207)
    Registrant - Niagara Pharmaceuticals, inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0160) , repack(0924-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation Vancouver Division080119599relabel(0924-0160) , repack(0924-0160)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc.205477792manufacture(0924-0160)
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