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

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

PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]
PDF | XML
NDC 65785-166-01, 65785-166-02
Set ID 7289103a-5cbf-42f4-8848-e827149a43ca
Category HUMAN OTC DRUG LABEL
Packager Niagara Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number NDA022305
View All Sections
  • 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 have any of the following

    • continued redness or irritation of the eye
    • condition worsens or persists
    • eye pain
    • changes in vision

    Keep out of reach of children.

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

  • Directions

    • pull cover off cap

    • avoid contamination of rim and inside surfaces of the eyecup

    • place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward

    • open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

  • Other information

    • lot number is printed on the bottle
    • store at 20° to 25° C [68° to 77° F]
    • do not use if tamper evident ring is 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 - 946 mL Bottle Label

    Pur-Wash ​TM

    Purified Water, 98.3%
    Ophthalmic Solution
    Eyewash With
    Sterile Eyecup Attached

    NDC 65785-166-02

    Single Use

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

    Sterile Solution

    32 Fl Oz [946 mL]

    PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PUR-WASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65785-166
    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:65785-166-01473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product05/24/2013
    2NDC:65785-166-02946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product05/24/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230505/24/2013
    Labeler - Niagara Pharmaceuticals Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals Inc.205477792manufacture(65785-166)
View All Sections

Related Drugs

Search DailyMed Drugs