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

  • NDC Code(s): 0023-0506-01, 0023-0506-50
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 15, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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°-86°F (15°-30°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?

    Figure1.800.433.8871

    refreshbrand.com

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-0506-01

    Preservative-free

    Refresh®
    Classic
    Lubricant Eye Drops

    Moisture drops
    for dry eyes

    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    Carton
  • INGREDIENTS AND APPEARANCE
    REFRESH CLASSIC 
    polyvinyl alcohol, povidone solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-0506
    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
    water (UNII: 059QF0KO0R)  
    sodium chloride (UNII: 451W47IQ8X)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-0506-0130 in 1 CARTON09/12/1985
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0023-0506-5050 in 1 CARTON09/12/1985
    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 FINALpart34909/12/1985
    Labeler - Allergan, Inc. (144796497)
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