PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]

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PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]
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NDC 65785-160-01, 65785-160-02
Set ID e07a064b-f680-405c-bbcd-24fac430951e
Category HUMAN OTC DRUG LABEL
Packager Niagara Pharmaceuticals 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 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Niagara Pharmaceuticals Inc.
    60 Innovation Dr.
    Flamborough ON L9H 7P3

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    Pur-Wash

    Purified Water, 98.3%
    Ophthalmic Solution
    Eyewash

    Single Use

    Manufactured by:
    Niagara Pharmaceuticals Inc.
    60 Innovation Dr.
    Flamborough ON L9H 7P3
    Made in Canada

    Sterile Solution

    4 Fl Oz [118 mL]

    Principal Display Panel - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PUR-WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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 CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65785-160-0130 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/12/2011
    2NDC:65785-160-02118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/12/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230509/12/2011
    Labeler - Niagara Pharmaceuticals Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals Inc.205477792manufacture(65785-160)
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