FDA.reportPublic FDA data

Refresh Optive Mega-3 PF

Manufacturer
Allergan, Inc.
Effective date
2026-03-01
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-09-11 03:01:24

Label at a glance#

ProductRefresh Optive Mega-3 PF
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80
Label structure9 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

Prior to first use, please read the “Instructions for Use” inside this carton. Instill 1 or 2 drops in the affected eye(s) as needed.

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. Replace cap after using.
  • 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

  • Prior to first use, please read the “Instructions for Use” inside this carton.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Use only if tape seals on top and bottom flaps are intact.
  • Use before expiration date marked on container.
  • Discard 90 days after opening.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON AND THE INSERT 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

V1.0DFL3988

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-3988-10

PRESERVATIVE-FREE

Refresh
OPTIVE
MEGA-3® PF
Lubricant Eye Drops

with HydroCell®

Fast-Acting Dry Eye Relief.

Formula Enhanced With
Flaxseed Oil*.

0.33 fl oz (10 mL) Sterile

NDC 0023-3988-10 PRESERVATIVE-FREE Refresh OPTIVE MEGA-3® PF Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief. Formula Enhanced With Flaxseed Oil*. 0.33 fl oz (10 ...NDC 0023-3988-10 PRESERVATIVE-FREE Refresh OPTIVE MEGA-3® PF Lubricant Eye Drops with HydroCell® Fast-Acting Dry Eye Relief. Formula Enhanced With Flaxseed Oil*. 0.33 fl oz (10 ...

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
0023-3988-10ML - Milliliter0023-3988f20d6031-a4d5-44f4-89fc-3f326c05eec912026-03-17

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
0023-39880023-3988-10, 0023-3988-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM HYDROXIDE55X04QC32ICNTM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-03-01full-release2026-06-01 01:56:49
42026-03-01monthly-update2026-06-03 17:58:24

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-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
ndc (package): 0023-3988-05
ndc (package): 0023-3988-10
ndc (product): 0023-3988
ndc11 (package): 00023398805
ndc11 (package): 00023398810
spl id: f1b7ee33-3765-45ca-8cf5-86422e001757
spl set id: 326cb5d6-c784-404f-9a13-6d69262dda6e

Reported adverse events (FAERS/openFDA)#

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