Label: QUALITY CHOICE LUBRICANT EYE DROPS RESTORATIVE PERFORMANCE- propylene glycol solution/ drops

  • NDC Code(s): 83324-028-15
  • Packager: Chain Drug Marketing Assoc., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Active ingredient

    Propylene glycol 0.6%

  • Purpose

    Lubricant

  • Use

    • for the temporary relief of burning and irritation due to dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if this product changes color
    • if you are sensitive to any ingredient in this product

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • shake well before using
    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients

    benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, **hydrochloric acid, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride, **sodium hydroxide

    **May contain these ingredients to adjust pH

  • Quality Choice Lubricant Eye Drops Restorative Performance 15mL

    Quality Choice Lubricant Eye Drops Restorative Performance 15mL

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE LUBRICANT EYE DROPS RESTORATIVE PERFORMANCE 
    propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-028
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL0.6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83324-028-151 in 1 BOX12/12/2023
    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 DrugM01812/12/2023
    Labeler - Chain Drug Marketing Assoc., Inc. (011920774)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daewoo Pharmaceuticals, Co., Ltd.689046329manufacture(83324-028) , pack(83324-028) , label(83324-028)
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