Label: REAL EYEWASH- eyewash solution

  • NDC Code(s): 59276-416-01, 59276-416-04, 59276-416-08, 59276-416-16, view more
    59276-416-32
  • Packager: Oliver Landon Intl Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 22, 2019

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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

    Stop use and ask a doctor if you have any of the following

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

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

  • 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 (800) 839-5929   9 a.m. to 5 p.m. EST Mon-Fri

  • Package/Label Principal Display Panel – 1 FL OZ (30 mL) label

    Real Eyewash 1 FL OZ (30 mL) front label
    Real Eyewash 1 FL OZ (30 mL) back label
  • Package/Label Principal Display Panel – 4 FL OZ (118 mL)

    Real Eyewash 4 FL OZ (118 mL) label
  • Package/Label Principal Display Panel – 8 FL OZ (236 mL)

    Real Eyewash 8 FL OZ (236 mL) label
  • Package/Label Principal Display Panel – 16 FL OZ (473 mL)

    Real Eyewash 16 FL OZ (473 mL) label
  • Package/Label Principal Display Panel – 32 FL OZ (946 mL)

    Real Eyewash 32 FL OZ (946 mL) label
  • INGREDIENTS AND APPEARANCE
    REAL EYEWASH 
    eyewash solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59276-416
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER0.983 mL  in 1 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:59276-416-0130 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/01/2015
    2NDC:59276-416-04118 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/01/2015
    3NDC:59276-416-08236 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/01/2015
    4NDC:59276-416-16473 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/01/2015
    5NDC:59276-416-32946 mL in 1 BOTTLE, UNIT-DOSE; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02230501/30/2015
    Labeler - Oliver Landon Intl Inc. (815240195)
    Registrant - Oliver Landon Intl Inc. (815240195)
    Establishment
    NameAddressID/FEIBusiness Operations
    Niagara Pharmaceuticals, Inc.205477792MANUFACTURE(59276-416)
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