Label: EYEWASH solution

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

Drug Label Information

Updated January 20, 2022

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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 materia.

  • Warnings

    For external use only

    Do not use

    • if you experience any open wounds in or near the eyes and obtain immediare 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 20º to 25º C [68º to 77º 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 800-634-7680

  • Eyewash Label

    pdp

  • INGREDIENTS AND APPEARANCE
    EYEWASH 
    eyewash solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68071-2234(NDC:47682-198)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.983 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BORIC ACID (UNII: R57ZHV85D4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68071-2234-4118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230512/02/2011
    Labeler - NuCare Pharmaceuticals,Inc. (010632300)
    Establishment
    NameAddressID/FEIBusiness Operations
    NuCare Pharmaceuticals,Inc.010632300relabel(68071-2234)
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