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
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 13, 2020

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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 finalpart34903/13/2020
    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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