Label: RUGBY LUBRICATING DROPS- polyvinyl alcohol solution/ drops

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

Drug Label Information

Updated November 20, 2024

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

  • 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 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 lens 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 reach of children.

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

  • Directions

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

    store at room temperature
    RETAIN CARTON FOR FULL DRUG FACTS INFORMATION
  • Inactive ingredients

    benzalkonium chloride (preservative), disodium edetate, purified water, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic.

    May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions & comments?

    Call 1-800-645-2158

  • TAMPER EVIDENT

    Do not use if tape seals on carton top and bottom flaps are damaged or missing.

    Distributed by:

    RUGBY LABORATORIES

    Livonia, MI 48152

    www.rugbylaboratories.com

    Made in India

    Code: MH/DRUGS/28-KD/283

    #302600

    Rev. 03/21

    R-169

    Re-order No. 302600

  • Principal Display Panel

    Rugby®

    NDC 0536-1325-94

    Polyvinyl

    Alcohol 1.4%

    Lubricating

    Eye Drops

    Relieves Dryness

    of the Eye

    Sterile

    0.5 FL OZ (15 mL)

    1.4% carton
  • 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, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED14 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1325-9415 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/202103/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/19/202103/30/2025
    Labeler - Rugby Laboratories (079246066)