FDA.reportPublic FDA data

REFRESH Optive Mega-3

Manufacturer
Allergan, Inc.
Effective date
2022-06-30
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-18 05:10:20

Label at a glance#

ProductREFRESH Optive Mega-3
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80
Label structure11 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%
Glycerin 1%
Polysorbate 80 0.5%

Purpose

OTC - PURPOSE SECTION

Eye lubricant
Eye lubricant
Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

  • 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

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1.800.678.1605

refresheyedrops.com

v2.0DFL5773

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-5773-30
PRESERVATIVE - FREE
Refresh
OPTIVE  
MEGA-3 ®
Lubricant Eye Drops  
with

HydroCell®

Fast-Acting Dry Eye Relief
Formula Enhanced With Flaxseed Oil*

30 Vials 0.01 fl oz (0.4 mL) each Sterile

PRINCIPAL DISPLAY PANEL NDC 0023-5773-30 PRESERVATIVE - FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief Formula Enhanced With Flaxseed...PRINCIPAL DISPLAY PANEL NDC 0023-5773-30 PRESERVATIVE - FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief Formula Enhanced With Flaxseed...

 

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-7151-60
VALUE SIZE 60 V IALS
PRESERVATIVE - FREE
Refresh
OPTIVE  
MEGA-3 ®
Lubricant Eye Drops

With
HydroCell®

Fast-Acting Dry Eye Relief
Formula Enhanced With Flaxseed Oil*

60 Vials 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 With HydroCell® Fast-Acting Dry Eye Relief Formula En...PRINCIPAL DISPLAY PANEL NDC 0023-7151-60 VALUE SIZE 60 VIALS PRESERVATIVE - FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops With HydroCell® Fast-Acting Dry Eye Relief Formula En...

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-4230-70
7 0 V IALS
PRESERVATIVE – FREE
Refresh
OPTIVE  
MEGA-3 ®
Lubricant Eye Drops

with 
HydroCell®

Fast-Acting Dry Eye Relief
Enhanced with Flaxseed Oil*

70 Vials 0.01 fl oz (0.4 mL) each Sterile

PRINCIPAL DISPLAY PANEL NDC 0023-4230-70 70 VIALS PRESERVATIVE – FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief Enhanced with Flaxsee...PRINCIPAL DISPLAY PANEL NDC 0023-4230-70 70 VIALS PRESERVATIVE – FREE Refresh OPTIVE MEGA-3® Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief Enhanced with Flaxsee...

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-7151-60EA - Each0023-7151bda715dc-5004-4b04-b9e1-805279df30a212021-07-15
0023-5773-30EA - Each0023-5773bac9de1e-5928-4149-b1cd-2be6cb44e26b12017-06-15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-71510023-7151-60
0023-57730023-5773-05, 0023-5773-30
0023-42300023-4230-70

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 45 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
GLYCERINPDC6A3C0OXACTIB
POLYSORBATE 806OZP39ZG8HACTIB
BORIC ACIDR57ZHV85D4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CASTOR OILD5340Y2I9GIACT
ERYTHRITOLRA96B954X6IACT
LINSEED OIL84XB4DV00WIACT
LEVOCARNITINE0G389FZZ9MIACT
POLYOXYL STEARATE 4013A4J4NH9IIACT
WATER059QF0KO0RIACT
TREHALOSEB8WCK70T7IIACT
SODIUM HYDROXIDE55X04QC32ICNTM
HYDROCHLORIC ACIDQTT17582CBCNTM
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
GLYCERINPDC6A3C0OXACTIB
POLYSORBATE 806OZP39ZG8HACTIB
BORIC ACIDR57ZHV85D4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CASTOR OILD5340Y2I9GIACT
ERYTHRITOLRA96B954X6IACT
LINSEED OIL84XB4DV00WIACT
LEVOCARNITINE0G389FZZ9MIACT
POLYOXYL STEARATE 4013A4J4NH9IIACT
WATER059QF0KO0RIACT
TREHALOSEB8WCK70T7IIACT
SODIUM HYDROXIDE55X04QC32ICNTM
HYDROCHLORIC ACIDQTT17582CBCNTM
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
GLYCERINPDC6A3C0OXACTIB
POLYSORBATE 806OZP39ZG8HACTIB
BORIC ACIDR57ZHV85D4IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
CASTOR OILD5340Y2I9GIACT
ERYTHRITOLRA96B954X6IACT
LINSEED OIL84XB4DV00WIACT
LEVOCARNITINE0G389FZZ9MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82022-06-30full-release2026-06-01 01:05:52

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
ndc (package): 0023-5773-05
ndc (package): 0023-5773-30
ndc (package): 0023-4230-70
ndc (package): 0023-7151-60
ndc (product): 0023-5773
ndc (product): 0023-7151
ndc (product): 0023-4230
ndc11 (package): 00023577330
ndc11 (package): 00023577305
ndc11 (package): 00023715160
ndc11 (package): 00023423070
spl id: 4b93ea93-0dbb-4cb7-aae3-e48f04060bd1
spl set id: c5f2b3f2-2071-45bd-a010-67f848bc0233

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.