Label: QUALITY CHOICE LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 63868-618-30
  • Packager: Chain Drug Marketing Assoc., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2023

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  • ACTIVE INGREDIENT

    Active ingredients

    Carboxymethylcellulose sodium.....0.5%

  • PURPOSE

    Purpose

    Lubricant

  • INDICATIONS & USAGE

    Uses

    • for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes or exposure to wind or sun
    • may be used as a protectant against further irritation
  • WARNINGS

    Warnings

    For external use only

    Do not use this product if

    • solution changes color or becomes cloudy

    When using this product

    • do not reuse
    • once opened, discard
    • to avoid contamination, do not touch tip of container to any surface
    • do not touch unit-dose tip to eye

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eye continues
    • redness or irritation of the eye 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 (1-800-222-1222) immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    • to open, twist and pull tab to remove
    • instill 1 or 2 drops in the affected eye(s) as needed and discard container
    • if used for post-operation (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions
  • OTHER SAFETY INFORMATION

    Other information

    • store at 15º-25ºC (59º-77ºF)
    • use only if single-use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • INACTIVE INGREDIENT

    Inactive ingredients calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate.

    **May contain these ingredients to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    carton

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-618
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-618-3030 in 1 CARTON03/13/2020
    10.4 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 DrugM01803/13/2020
    Labeler - Chain Drug Marketing Assoc., Inc. (011920774)
    Registrant - K.C. Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052manufacture(63868-618) , pack(63868-618) , label(63868-618)
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