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

  • NDC Code(s): 0023-4307-03, 0023-4307-10, 0023-4307-20
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL

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 June 15, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    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. Replace cap after using.
    • 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

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

  • 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.
    • Discard 90 days after opening.
    • Store at 59°-86°F (15°-30°C).
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; castor oil; erythritol; levocarnitine; carbomer copolymer type A; purified water; and PURITE® (stabilized oxychloro complex). May also contain sodium hydroxide to adjust pH.

  • Questions or comments?

    Telephone1.800.678.1605

    refreshbrand.com

    © 2017 Allergan. All rights reserved.
    All trademarks are the property of their respective owners.
    Revised: June 2, 2017

  • PRINCIPAL DISPLAY PANEL

    Refresh

    Optive®

    ADVANCED

    Lubricant Eye Drops

    TRIPLE-ACTION RELIEF

    Clinically proven to lubricate,

    hydrate, and protect

    natural tears from evaporating

    0.33 fl oz (10 mL) Sterile

    Principal Display Panel Carton
  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE ADVANCED 
    carboxymethylcellulose sodium, glycerin, and polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-4307
    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)  
    castor oil (UNII: D5340Y2I9G)  
    erythritol (UNII: RA96B954X6)  
    levocarnitine (UNII: 0G389FZZ9M)  
    carbomer copolymer type A (UNII: 71DD5V995L)  
    water (UNII: 059QF0KO0R)  
    sodium chlorite (UNII: G538EBV4VF)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-4307-031 in 1 CARTON11/30/2011
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-4307-101 in 1 CARTON11/30/2011
    210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0023-4307-202 in 1 CARTON11/30/2011
    310 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34911/30/2011
    Labeler - Allergan, Inc. (144796497)