Label: POLYVINYL ALCOHOL W/POVIDON1.4-0.6%- polyvinyl alcohol, povidon liquid

  • NDC Code(s): 0536-1399-92, 0536-1399-93
  • Packager: Rugby Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active ingredient

    Polyvinyl Alcohol (1.4%)

    Povidone (0.6%)

  • Purpose

    Eye 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

    • For use in eyes only.

    • Using this product, to avoid contamination, do not touch tip of container to any surface.

    • Do not reuse. Once opened, discard after use.

    • Do not touch single-use container tip to the eye.

    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.

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • Directions

    To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

  • Other information

    • Store at 59°-86° F (15°-30°C)

    • Use only if single-use container is intact.

  • Inactive ingredients

    Calcium chloride, Hydrochloric acid, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Sodium lactate.

  • Questions or comments?

    Call (888) 969-6855

  • Do not use

    • If solution changes color or becomes cloudy.

    DO NOT USE IF TAMPER EVIDENT SEAL IS TORN, BROKEN OR MISSING

  • Save carton for complete drug facts.

    *This product is not manufactured or distributed by Allergan, Inc., owner of the registered trademark Refresh® Classic Lubricant Eye Drops.

    Distributed by:

    RUGBY LABORATORIES

    Indianapolis, IN 46268

    Questions or comments?

    Call (800) 616-2471

    www.majorpharmaceuticals.com

    Rev. 08/23

    R-155

    Re-order No. 371162

    Rev. 08/23

    R-155

    Re-order No. 371163
  • Principal Display Panel

    Rugby®

    NDC 0536-1399-92

    Compare to the active

    ingredients in Refresh®

    Classic Lubricant

    Eye Drops*

    Preservative-Free

    Polyvinyl Alcohol

    w/Povidone

    1.4-0.6% Drops

    Soothes, Moisturizes,

    Protects & Lubricates

    Sterile

    30 Single-Use Containers

    0.01 FL OZ (0.4 mL) each

    1.4-0.6% - 30s carton
  • Principal Display Panel

    Rugby®

    NDC 0536-1399-93

    Compare to the active

    ingredients in Refresh®

    Classic Lubricant

    Eye Drops*

    Preservative-Free

    Polyvinyl Alcohol

    w/Povidone

    1.4-0.6% Drops

    Soothes, Moisturizes,

    Protects & Lubricates

    Sterile

    50 Single-Use Containers

    0.01 FL OZ (0.4 mL) each

    1.4-0.6% - 50s carton
  • INGREDIENTS AND APPEARANCE
    POLYVINYL ALCOHOL W/POVIDON1.4-0.6% 
    polyvinyl alcohol, povidon liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1399
    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
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE ANHYDROUS (UNII: 59XN63C8VM)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1399-9230 in 1 CARTON10/01/202310/01/2023
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0536-1399-9350 in 1 CARTON10/01/202310/01/2023
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/01/202310/01/2023
    Labeler - Rugby Laboratories (079246066)
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