Label: RUGBY LUBRICATING DROPS- polyvinyl alcohol solution/ drops

  • 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 19, 2021

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  • Active ingredient

    Polyvinyl Alcohol 1.4%

  • Purpose

    Lubricant

  • Uses

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

    • Do not use if solution changes color or becomes cloudy

     

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • remove contact lens before using.
    • 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
    • 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

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

    • store at room temperature
    • keep tightly closed
    • replace cap after use
    • retain carton for full drug facts

  • 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 1-800-645-2158

  • Package/Label Principal Display Panel

    1

  • INGREDIENTS AND APPEARANCE
    RUGBY LUBRICATING DROPS 
    polyvinyl alcohol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1325
    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
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1325-9415 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/19/2021
    Labeler - Rugby (079246066)
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