Label: ARTIFICIAL TEARS- polyvinyl alcohol solution/ drops

  • NDC Code(s): 0536-1970-72
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/11

If you are a consumer or patient please visit this version.

  • Active ingredient

    Polyvinyl Alcohol 1.4%

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  • Purpose

    Lubricant

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  • Uses

    • relieves dryness of the eye
    • prevents further irritation
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  • Warnings

    • Do not use if solution changes color or becomes cloudy
    • with contact lenses

    When using this product  

    • do not touch tip of container to any surface to avoid contamination
    • 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
    • condition worsens or lasts for more than 72 hours
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  • Keep out of reach of children.

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

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  • Directions

    • instill 1 to 2 drops in the affected eye(s) as needed.
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  • Other information

    • store at 15° - 30°C (59° - 86°F)
    • keep tightly closed

     

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  • 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%

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  • Questions or comments?

    Call 1-800-645-2158

    9 am - 5 pm ET, Monday-Friday.

    Serious side effects associated with use of this product may be reported to this number

    Rugby ®

    Duluth, GA 30097

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  • Package/Label Principal Display Panel

    Carton

    NDC 0536-1970-72

    Rugby®

    COMPARED TO ACTIVE INGREDIENTS IN LIQUIFILM® TEARS*

    Artificial Tears Solution

    Polyvinyl Alcohol 1.4%

    Lubricant Eye

    Drops (Sterile)

    Prevents irritation and relieves Dryness of the eye

    Rugby®

    1/2 fl oz (15 mL)

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  • INGREDIENTS AND APPEARANCE
    ARTIFICIAL TEARS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0536-1970
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POLYVINYL ALCOHOL (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL 14 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PHOSPHATE, DIBASIC  
    EDETATE DISODIUM  
    SODIUM PHOSPHATE, MONOBASIC  
    SODIUM CHLORIDE  
    WATER  
    BENZALKONIUM CHLORIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0536-1970-72 15 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 10/07/2011
    Labeler - Rugby Laboratories Inc. (109178264)
    Registrant - Bausch & Lomb Incorporated (196603781)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 196603781 MANUFACTURE
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