Label: POLYVINYL ALCOHOL W/POVIDON1.4-0.6%- polyvinyl alcohol, povidon liquid

  • NDC Code(s): 0536-1399-92, 0536-1399-93
  • Packager: RUGBY LABORATORIES
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 31, 2023

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  • Active ingredient

    Polyvinyl Alcohol (1.4%)

    Povidone (0.6%)

  • Purpose

    Eye lubricant

  • Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation.
  • Warnings

    • For use in eyes only. • Using this product, to avoid contamination, do not touch tip of container to any surface.

    • Do not reuse. Once opened, discard after use.

    • Do not touch single-use container tip to the eye.

    Stop use and ask a doctor if

    • You experience eye pain, changes in vision, continued redness, or irritation of the eye.

    • The condition worsens or persists for more than 72 hours.

    Keep out of reach of children.

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • Directions

    To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

  • Other information

    • Store at 59°-86° F (15°-30°C)

    • Use only if single-use container is intact.

  • Inactive ingredients

    Calcium chloride, Hydrochloric acid, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Sodium lactate.

  • Questions or comments?

    Call (888) 969-6855

  • Do not use

    Do not use: • If solution changes color or becomes cloudy.

  • PRINCIPAL DISPLAY PANEL

    Carton

    Carton

  • INGREDIENTS AND APPEARANCE
    POLYVINYL ALCOHOL W/POVIDON1.4-0.6% 
    polyvinyl alcohol, povidon liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1399
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1399-9230 in 1 CARTON10/01/2023
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0536-1399-9350 in 1 CARTON10/01/2023
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01809/19/2023
    Labeler - RUGBY LABORATORIES (079246066)
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