Label: LUBRICATING EYE DROPS- carboxymethylcellulose sodium liquid

  • NDC Code(s): 73141-001-01, 73141-001-02, 73141-001-03, 73141-001-04, view more
    73141-001-05
  • Packager: A2A Integrated Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL

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 October 7, 2019

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  • Active Ingredient                                                                    Purpose

    Carboxymethylcellulose sodium 0.5%------------------------- Eye lubricant

  • PURPOSE

  • Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation of the eye.
  • Warnings

    For external use only

    • Do not use if solution changes color or becomes cloudy.

    When using this product

    to avoid contamination, do no touch tip of container to any surface. Do not reuse. Once open, discard.

    Do not touch unit dose tip to eye.

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye or if the condition worsens or persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    ■ TWIST AND REMOVE TAB.

    ■ Place 1 or 2 drops in the affected eye(s) as needed for relief and discard container.
    ■ If used for post-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.

  • Inactive Ingredients

    Calcium chloride, hydrochloric acid*, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide*, and sodium
    lactate.*May or may not contain this ingredient to adjust pH.

  • Other information

    ■ Use only if single-use container is intact.
    ■ Use before expiration date marked on container.
    ■ RETAIN THIS FOIL FOR FUTURE REFERENCE.

  • Principal display panel

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  • INGREDIENTS AND APPEARANCE
    LUBRICATING EYE DROPS 
    carboxymethylcellulose sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73141-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) (CARBOXYMETHYLCELLULOSE - UNII:05JZI7B19X) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73141-001-018 in 1 CARTON10/04/2019
    10.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:73141-001-0232 in 1 CARTON10/04/2019
    20.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    3NDC:73141-001-0352 in 1 CARTON10/04/2019
    30.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    4NDC:73141-001-0472 in 1 CARTON10/04/2019
    40.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    5NDC:73141-001-05100 in 1 CARTON10/04/2019
    50.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/04/2019
    Labeler - A2A Integrated Pharmaceuticals, LLC (117064671)
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