DYNAMIC EYEWASH (WATER) SOLUTION [DYNAMIC SAFETY INTERNATIONAL]

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DYNAMIC EYEWASH (WATER) SOLUTION [DYNAMIC SAFETY INTERNATIONAL]
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NDC 72745-100-01, 72745-100-04, 72745-100-08, 72745-100-16, 72745-100-32
Set ID 7d3aaa10-c604-4dff-e053-2991aa0abd92
Category HUMAN OTC DRUG LABEL
Packager Dynamic Safety International
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 1-887-446-3278 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 - DRUG FACTS

    32 oz16 oz8 oz4 oz1 oz

  • INGREDIENTS AND APPEARANCE
    DYNAMIC EYEWASH 
    water solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72745-100
    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:72745-100-0130 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/17/2018
    2NDC:72745-100-04118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/17/2018
    3NDC:72745-100-08236 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/17/2018
    4NDC:72745-100-16473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/17/2018
    5NDC:72745-100-32946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product12/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230512/17/2018
    Labeler - Dynamic Safety International (244256769)
    Registrant - Niagara Pharmaceuticals Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals Inc.205477792manufacture(72745-100)
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