Label: GOOD SENSE ARTIFICIAL TEARS- polyvinyl alcohol, povidone solution

  • NDC Code(s): 50804-110-01
  • Packager: Geiss, Destin & Dunn, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Polyvinyl alcohol.....0.5%

    Povidone......0.6%

  • PURPOSE

    Purposes

    Polyvinyl alcohol ...Eye lubricant

    Povidone ...Eye lubricant

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

    Do not use this product if solution changes color or becomes cloudy

    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 immediately.

    When using this product

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

    Directions

    Instill 1 or 2 drops in the affected eye(s) as needed.

  • OTHER SAFETY INFORMATION

    Other information

    • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
    • Store at 15º-30º C (59º-86ºF)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    GOOD SENSE ARTIFICIAL TEARS 
    polyvinyl alcohol, povidone solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-110
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) (POLYVINYL ALCOHOL, UNSPECIFIED - UNII:532B59J990) POLYVINYL ALCOHOL, UNSPECIFIED0.5 g  in 100 mL
    POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E) POVIDONE0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-110-011 in 1 BOX01/02/2020
    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 DrugM01801/02/2020
    Labeler - Geiss, Destin & Dunn, Inc. (076059836)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.C. Pharmaceuticals, Inc.174450460manufacture(50804-110) , pack(50804-110) , label(50804-110)
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