Label: REFRESH CLASSIC- polyvinyl alcohol, povidone solution/ drops

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

Drug Label Information

Updated March 14, 2024

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  • Active ingredients

    Polyvinyl Alcohol 1.4%

    Povidone 0.6%

  • Purpose

    Eye lubricant

    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 external use only.
    • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
    • Do not touch unit-dose tip to eye.
    • If solution changes color or becomes cloudy, do not use.

    Stop use and ask a doctor if

    you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

    Keep out of reach of children.

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

  • 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

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • Store at 59°-77°F (15°-25°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Purified water and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

  • Questions or comments?

    1.800.678.1605

    refreshbrand.com

    v1.0DFL0506

  • HOW SUPPLIED

    Product: 50090-2358

    NDC: 50090-2358-1 .4 mL in a VIAL, SINGLE-USE / 30 in a CARTON

  • Polyvinyl Alcohol, Povidone

    Label Image
  • INGREDIENTS AND APPEARANCE
    REFRESH CLASSIC 
    polyvinyl alcohol, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-2358(NDC:0023-0506)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990) POLYVINYL ALCOHOL14 mg  in 1 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-2358-130 in 1 CARTON04/21/2016
    1.4 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 DrugM01809/12/1985
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-2358)
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