Label: POLYVINYL ALCOHOL solution/ drops

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

Drug Label Information

Updated May 14, 2024

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  • Active ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    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

    • Do not use if solution changes color or becomes cloudy

     

    When using this product

    • Avoid contamination, do not touch tip of container to any surface.
    • Replace cap after use

    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.

    If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

  • Directions

    • Shake well before use
    • instill 1 to 2 drops in the affected eye(s) as needed
  • Other information

    • Store at room temperature 15-30C (59-86F)
    • Do No Use if imprinted seal on cap is torn, broken or missing
    • Discard 90 days after opening
    • Retain outer carton for full product information

  • Inactive ingredients

    dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

    purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

  • Questions ?

    Call 1-855-361-3993

    Distributed by:

    AvKARE

    Pulaski, TN 38478

    www.avkare.com

    Rev. 12/2022 AV 12/2022

  • Package/Label Principal Display Panel

    15

  • INGREDIENTS AND APPEARANCE
    POLYVINYL ALCOHOL 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50268-678
    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
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50268-678-1515 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/05/2023
    Labeler - AvPAK (832926666)
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