Label: REFRESH OPTIVE ADVANCED- carboxymethylcellulose sodium, glycerin, polysorbate 80 solution/ drops

  • NDC Code(s): 0023-4491-05, 0023-4491-30
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated September 15, 2022

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  • SPL UNCLASSIFIED SECTION

    Refresh Optive ADVANCED (Preservative-free) 

    Drug Facts

  • Active ingredients

    Carboxymethylcellulose sodium 0.5%

    Glycerin 1%

    Polysorbate 80 0.5%

  • Purpose

    Eye lubricant

    Eye lubricant

    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.
  • Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.
    • Do not touch unit-dose tip to eye.
    • If solution changes color, 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.

  • Directions

    To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

  • Other information

    • Use only if single-use container is intact.
    • Use before expiration date marked on container.
    • Store at 59°-77°F (15°-25°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide (to adjust pH).

  • Questions or comments?

    1.800.678.1605

    refreshbrand.com

    v1.0DFL4491

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-4491-30

    Single Use Containers
    Preservative-free

    Refresh
    Optive®
    ADVANCED
    Lubricant Eye Drops

    TRIPLE-ACTION RELIEF

    Clinically proven to lubricate, hydrate,
    and protect natural tears from evaporating

    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    PRINCIPAL DISPLAY PANEL NDC 0023-4491-30 Single Use Containers Preservative-free Refresh Optive® ADVANCED Lubricant Eye Drops TRIPLE-ACTION RELIEF Clinically proven to lubricate, hydrate, and protect natural tears from evaporating 30 Single-Use Containers 0.01 fl oz (0.4 mL) each Sterile      

  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE ADVANCED 
    carboxymethylcellulose sodium, glycerin, polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-4491
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    carboxymethylcellulose sodium (UNII: K679OBS311) (carboxymethylcellulose - UNII:05JZI7B19X) carboxymethylcellulose sodium5 mg  in 1 mL
    glycerin (UNII: PDC6A3C0OX) (glycerin - UNII:PDC6A3C0OX) glycerin10 mg  in 1 mL
    polysorbate 80 (UNII: 6OZP39ZG8H) (polysorbate 80 - UNII:6OZP39ZG8H) polysorbate 805 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    boric acid (UNII: R57ZHV85D4)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    castor oil (UNII: D5340Y2I9G)  
    erythritol (UNII: RA96B954X6)  
    levocarnitine (UNII: 0G389FZZ9M)  
    water (UNII: 059QF0KO0R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-4491-055 in 1 CARTON01/15/2013
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0023-4491-3030 in 1 CARTON01/15/2013
    20.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/15/2013
    Labeler - Allergan, Inc. (144796497)
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