Label: MOISTURIZING LUBRICANT- carboxymethylcellulose sodium solution/ drops 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Carboxymethylcellulose Sodium 0.5%

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  • Purpose

    Lubricant

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  • Uses

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

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
    • If solution changes color or becomes cloudy, do not use.

    Stop use and ask a doctor if

    • you feel eye pain.
    • changes in vision occur.
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1 -800-222-1222).

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  • Directions

    • Instill 1 or 2 drops in the affected eye(s) as needed.
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  • Other Information

    • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.
    • Use before expiration date marked on container.

    • Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
    • Retain this carton for future reference.
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  • Inactive Ingredients:

    Purified Water, Boric Acid, Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride. May also contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH;

    Preservative: Chlorine Dioxide 2% solution.

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  • Questions or comments?

    1-800-632-6900

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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Container Label:

    30142-338-04

    Kroger Logo®

    STERILE

    eye drops

    moisturizing

    lubricant

    CMC 0.5% Lubricant Eyedrops

    0.5 FL OZ (15 mL)

    Principal Display Panel Text for Container Label
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  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel Text for Carton Label:

    COMPARE TO the active Ingredients of

    REFRESH TEARS®*See side panel

    30142-338-04

    Kroger Logo®

    FROM OUR FAMILY

    TO YOURS

    STERILE

    eye drops

    moisturizing

    lubricant

    CMC 0.5% Lubricant Eyedrops

    Lubricant eye drops

    Moisturizing Drops

    for Dry Eyes

    0.5 FL OZ (15 mL)

    Principal Display Panel Text for Carton Label
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  • INGREDIENTS AND APPEARANCE
    MOISTURIZING LUBRICANT 
    carboxymethylcellulose sodium solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:30142-338
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Carboxymethylcellulose Sodium (Carboxymethylcellulose) Carboxymethylcellulose Sodium 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    Boric Acid  
    Sodium Chloride  
    Potassium Chloride  
    Calcium Chloride  
    Magnesium Chloride  
    Hydrochloric Acid  
    Sodium Hydroxide  
    Chlorine Dioxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30142-338-04 1 in 1 CARTON
    1 15 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 02/22/2013
    Labeler - Kroger Company (006999528)
    Registrant - Akorn, Inc. (063434679)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn, Inc 603980319 MANUFACTURE(30142-338), ANALYSIS(30142-338), STERILIZE(30142-338), PACK(30142-338), LABEL(30142-338)
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