Label: EYES ALIVE LUBRICATING- carboxymethylcellulose sodium liquid

  • 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 December 7, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each unit dose)

    Carboxymethylcellulose sodium 0.5%

  • Purpose

    Eye lubricant

  • 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 not 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. 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.
  • Other Information

    • Use only if single-use container in intact.
    • Use before expiration date marked on container.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Calcium chloride, hydrochloric acid1, magnesium chloride, potassium chloride, purified water, sodium chloride, sodium hydroxide1, and sodium lactate.

    1
    May or may not contain this ingredient to adjust pH.
  • Questions or comments?

    800.477.2884, M-F 8 AM – 5 PM Eastern Time

    You can also report serious side effects to this number.

  • PRINCIPAL DISPLAY PANEL - 32 Ampule Carton

    NDC 69183-200-32

    Eyes
    Alive™

    Lubricating Eye Drops
    Lubricant/carboxymethylcellulose sodium

    Long lasting moisturizing
    drops to keep your
    Eyes Feeling Alive!

    IMMEDIATE RELIEF FOR
    DRY IRRITATED EYES

    32 Sterile Single-Use Containers
    0.02 fl oz (0.6 mL) each

    MADE IN THE USA

    Principal Display Panel - 32 Ampule Carton
  • INGREDIENTS AND APPEARANCE
    EYES ALIVE   LUBRICATING
    carboxymethylcellulose sodium liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69183-200
    Route of AdministrationINTRAOCULAR
    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:69183-200-022 in 1 POUCH02/01/2015
    10.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:69183-200-044 in 1 POUCH02/01/2015
    20.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    3NDC:69183-200-3232 in 1 CARTON02/01/2015
    30.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    4NDC:69183-200-5252 in 1 CARTON02/01/2015
    40.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    5NDC:69183-200-7272 in 1 CARTON02/01/2015
    50.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    6NDC:69183-200-00100 in 1 CARTON02/01/2015
    60.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    7NDC:69183-200-088 in 1 CARTON02/01/2015
    70.6 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34902/01/2015
    Labeler - DIVISION 5 LABS, INC. (968198288)
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