Label: HEB LUBRICANT EYE DROPS- carboxymethylcellulose sodium solution/ drops

  • 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 February 23, 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

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  • INGREDIENTS AND APPEARANCE
    HEB LUBRICANT EYE DROPS 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-100
    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:37808-100-0130 in 1 CARTON01/11/2019
    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 finalpart34901/11/2019
    Labeler - HEB (007924756)
    Registrant - Unimed Pharmaceuticals, Inc. (689852052)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unimed Pharmaceuticals, Inc.689852052label(37808-100) , manufacture(37808-100) , pack(37808-100)
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