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

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, 2021

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

  • 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 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?

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    v1.0DFL5773

  • PRINCIPAL DISPLAY PANEL

    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

    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

    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

    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:0023-5773
    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 finalpart34905/30/2017
    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 finalpart34906/15/2021
    Labeler - Allergan, Inc. (144796497)