Label: FIRSTEP FIRSTFLUSH- eyewash solution

  • NDC Code(s): 70290-310-32
  • Packager: Encon Safety Products, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 28, 2020

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  • Active ingredient

    Purified water 98.3%

  • Purpose

    Eyewash

  • 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

  • Use

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

  • 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

    • remove tamper evident seal and cap
    • 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 973-227-1830 9 a.m. to 5 p.m. EST Mon-Fri

  • Dosage and Administration

    • remove tamper evident seal and cap
    • flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
  • Warnings

    For external use only

  • Package Label.Principal Display Panel

    Encon

  • INGREDIENTS AND APPEARANCE
    FIRSTEP FIRSTFLUSH 
    eyewash solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70290-310
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER465 mL  in 473 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:70290-310-32946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230504/27/2020
    Labeler - Encon Safety Products, Inc. (008102410)
    Registrant - Niagara Pharmaceuticals, Inc. (205477792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc.205477792manufacture(70290-310)
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