Label: REFRESH OPTIVE MEGA-3- carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops

  • NDC Code(s): 0023-5773-05, 0023-5773-30, 0023-7151-60
  • Packager: Allergan, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 30, 2022

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  • 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).
    • Store vials in the pouch until use.
    • RETAIN THIS CARTON FOR FUTURE REFERENCE.
  • Inactive ingredients

    Boric acid; butylated hydroxyl toluene; carbomer copolymer type A; castor oil; erythritol; flaxseed oil; levocarnitine; polyoxyl 40 stearate; purified water; and trehalose. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

  • Questions or comments?

    1.800.678.1605
    refreshbrand.com
    v1.0DFL5773

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-5773-30

    Preservative-free
    Refresh
    Optive    ® 
    MEGA-3
    Lubricant Eye Drops
    ENHANCED WITH FLAXSEED OIL
    Prevents tear evaporation and restores all
    three layers of the tear film damaged by Dry Eye.
    30 Single-Use Containers
    0.01 fl oz (0.4 mL) each Sterile

    NDC 0023-5773-30 Preservative-free Refresh Optive® MEGA-3 Lubricant Eye Drops ENHANCED WITH FLAXSEED OIL Prevents tear evaporation and restores all three layers of the tear film damaged by Dry Eye. 30 Single-Use Containers 0.01 fl oz (0.4 mL) each Sterile

  • PRINCIPAL DISPLAY PANEL

    NDC 0023-7151-60

    VALUE SIZE 60 Vials

    PRESERVATIVE-FREE
    Refresh
    OPTIVE 
    MEGA-3®
    Lubricant Eye Drops
    For Eye Dryness 

    with HydroCell™

    Moisture-rich Relief
    Protects Tears from Evaporating

    60 Vials 0.01 fl oz (0.4 mL) each Sterile

    NDC 0023-7151-60 VALUE SIZE 60 Vials PRESERVATIVE-FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops For Eye Dryness with HydroCell™ Moisture-rich Relief Protects Tears from Evaporating 60 Vials 0.01 fl oz (0.4 mL) each Sterile

  • INGREDIENTS AND APPEARANCE
    REFRESH OPTIVE MEGA-3 
    carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-7151
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-7151-6060 in 1 BOX06/15/2021
    10.4 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 DrugM01806/15/2021
    REFRESH OPTIVE MEGA-3 
    carboxymethylcellulose sodium, glycerin and polysorbate 80 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0023-5773
    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)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ERYTHRITOL (UNII: RA96B954X6)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    LEVOCARNITINE (UNII: 0G389FZZ9M)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    TREHALOSE (UNII: B8WCK70T7I)  
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    May containSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    May containHYDROCHLORIC ACID (UNII: QTT17582CB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-5773-055 in 1 BOX05/30/2017
    10.4 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    2NDC:0023-5773-3030 in 1 BOX05/30/2017
    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 DrugM01805/30/2017
    Labeler - Allergan, Inc. (144796497)
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