Label: POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 27, 2024

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  • Active ingredient

    Polyvinyl Alcohol Eye Drops 1.4 % w/v

  • DIRECTIONS FOR USE

    • lnstill 1or 2 drops in the affected eye, as needed
  • INACTIVE INGREDIENT

    1.Boric acid

    2.Calcium chloride

    3.Glycerin
    4.Magnesium chloride

    5.Mannitol

    6.Potassium chloride

    7.Purified water

    8.Stablized oxy cholro complex

    9.Sodium tetra borate
    10.Sodium hyaluronate

    11.Sodium citrate

  • Tamper Protection

    • For your protection a tamper evident ring is attached to the bottlecap
    • Upon opening, this will separate from the cap and can be discarded
    • Use only if this ring is present and attached when the bottle is first opened
  • Use

    For use as a lubricant to prevent further irritation or to relieve dryness of the eye

  • Questions

    Call. 1-800-103-7321
    E-mail : info@aurolab.com
    Web : www.aurolab.com

  • Keep out of reach of children

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

  • Stop use and ask a doctor if

    1. If you experience eye pain
    2. change in vision
    3. Continued Redness or irritaion of teh eye
    4. Condition worsens or persists for mroe than 72 hours

  • Do not use

    1.If you are sensitive to any ingredient in this product
    2.If solution changes color or becomes cloudy

  • Warnings

    For external use only

  • Indication & usage

    Do not touch the nozzle tip to any surface since this may contaminate the solution
    Remove contact lenses before use Should not use at the same time as other ophthalmic drugs
    Replace cap after using

  • Dose

    Instill 1 or 2 drops in the affected eyes as needed

  • Eye lubricant

    Eye lubricant

  • Carton

    PVA

  • INGREDIENTS AND APPEARANCE
    POLYVINYL ALCOHOL EYE DROPS 1,4 % W/V 
    polyvinyl alcohol eye drops 1,4 % w/v for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16030-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POVIDONE (UNII: FZ989GH94E)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:16030-201-1010 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product09/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01809/20/2022
    Labeler - Aurolab (677319965)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurolab677319965manufacture(16030-201)
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