Label: REFRESH OPTIVE- carboxymethylcellulose sodium and glycerin solution/ drops

  • NDC Code(s): 0023-3240-01, 0023-3240-03, 0023-3240-15
  • Packager: Allergan, Inc.
  • 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 02/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

    Glycerin 0.9%

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  • Purpose

    Eye lubricant

    Eye lubricant

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  • 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.
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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 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.

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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.
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
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  • Inactive ingredients

    Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium citrate dihydrate.

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  • Questions or comments?

    Telephone
1.800.433.8871
    refreshbrand.com

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  • PRINCIPAL DISPLAY PANEL

    Refresh
    Optive
    ®
    Lubricant Eye Drops

    LONG-LASTING HYDRATION

    Lubricating and hydrating
    formula penetrates the
    surface to relieve dryness

    0.5 fl oz (15 mL) Sterile

    Carton
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  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE 
    carboxymethylcellulose sodium and glycerin solution/ drops
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0023-3240
    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
    glycerin (glycerin) glycerin 9 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    boric acid  
    calcium chloride  
    erythritol  
    levocarnitine  
    magnesium chloride  
    potassium chloride  
    water  
    sodium chlorite  
    sodium chlorate  
    chlorine dioxide  
    sodium borate  
    trisodium citrate dihydrate  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0023-3240-03 1 in 1 CARTON
    1 3 mL in 1 BOTTLE, DROPPER
    2 NDC:0023-3240-15 1 in 1 CARTON
    2 15 mL in 1 BOTTLE, DROPPER
    3 NDC:0023-3240-01 2 in 1 CARTON
    3 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 09/06/2006
    Labeler - Allergan, Inc. (144796497)
    Establishment
    Name Address ID/FEI Business Operations
    Allergan, Inc. 362898611 MANUFACTURE(0023-3240)
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