Label: MAJOR LUBRICATING EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 0904-6848-46, 0904-6848-51
  • Packager: Harvard Drug Group L L C
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2023

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  • Active ingredient

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Lubricant

  • 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

    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.

  • 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-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor's instructions
  • Other information

    • store at 15°-25°C (59°-77°)
    • use only if single use container is intact
    • use before expiration date marked on container
    • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • 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.

  • Questions or comments?

    Call (800) 616-2471

  • Major Lubricating Eye Drops 30ct

    Major Lubricating Eye Drops 30ct

  • Major Lubricating Eye Drops 50ct

    Major Lubricating Eye Drops 50ct

  • INGREDIENTS AND APPEARANCE
    MAJOR LUBRICATING EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6848
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6848-5150 in 1 BOX06/23/2020
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0904-6848-4630 in 1 BOX06/23/2020
    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 DrugM01806/23/2020
    Labeler - Harvard Drug Group L L C (191427277)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460pack(0904-6848)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed689852052manufacture(0904-6848) , label(0904-6848) , pack(0904-6848)
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