Label: SIGNATURE CARE LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • NDC Code(s): 21130-705-01
  • Packager: Better Living Brands LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

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  • ACTIVE INGREDIENT

    Active ingredient
    Carboxymethylcellulose sodium 0.5%

  • PURPOSE

    Purpose
    Carboxymethylcellulose sodium.............Lubricant

  • INDICATIONS & USAGE

    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
  • WARNINGS

    ​Warnings

    For external use only.

    ​ Do not use this product if

    • solution changes color or becomes cloudy

    When using the 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 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-operative (e.g., LASIK) dryness and discomfort, follow your eye doctor’s instructions.
  • OTHER SAFETY INFORMATION

    Other information

    • store at 15°-25°C (59°-77°F).
    • 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, magnesium chloride, potassium chloride, purified water, sodium
    chloride, and sodium lactate. May contain sodium hydroxide and/or hydrochloric acid
    to adjust pH.

  • PRINCIPAL DISPLAY PANEL

    box

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-705
    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)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-705-0130 in 1 CARTON04/11/2019
    10.4 mL in 1 VIAL, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01804/11/2019
    Labeler - Better Living Brands LLC (009137209)
    Registrant - Unimed Pharmaceuticals, Inc. (689852052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052label(21130-705) , manufacture(21130-705) , pack(21130-705)
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