Label: RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS- polyvinyl alcohol solution/ drops

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

Drug Label Information

Updated October 19, 2023

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  • Active ingredient

    Polyvinyl alcohol 1.4%

  • Purpose

    Lubricant

  • Uses

    • for use as a protectant against further irritation or to relieve dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
  • Warnings

    For external use only

    Do not use this product if

    • solution changes color or becomes cloudy

    When using this product

    • remove contact lenses before using
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using. Keep container tightly closed.

    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 the reach of children.

    If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

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

    • keep in a dry place
    • store at 15°-25°C (59°-77°F)
    • store away from sources of heat or ignition
  • Inactive ingredients

    benzalkonium chloride, dibasic sodium phosphate hydrate, disodium edetate hydrate, monobasic sodium phosphate dihydrate, sodium chloride, water for injection.

  • Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

    Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15mL

  • INGREDIENTS AND APPEARANCE
    RUGBY POLYVINYL ALCOHOL 1.4% LUBRICATING EYE DROPS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1408
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED1.4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC, DODECAHYDRATE (UNII: E1W4N241FO)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE (UNII: 5QWK665956)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1408-941 in 1 BOX10/19/2023
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/19/2023
    Labeler - Rugby Laboratories (079246066)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hanlim Pharm. Co., LTD.687986034manufacture(0536-1408) , pack(0536-1408) , label(0536-1408)
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