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
  • 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 July 2, 2020

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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 finalpart34906/23/2020
    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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