FDA.reportPublic FDA data

REFRESH OPTIVE Advanced

Manufacturer
Allergan, Inc.
Effective date
2022-09-15
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:39:00

Label at a glance#

ProductREFRESH OPTIVE Advanced
Active ingredientcarboxymethylcellulose sodium, glycerin, polysorbate 80
Label structure10 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#

SPL UNCLASSIFIED SECTION

Refresh OPTIVE®ADVANCED (Preservative-free) 

Drug Facts

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).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid; carbomer copolymer type A; castor oil; erythritol; levocarnitine; purified water; and sodium hydroxide (to adjust pH).

Questions or comments?

OTC - QUESTIONS SECTION

1.800.678.1605

refresheyedrops.com

v1.0DFL4491

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-4491-30

PRESERVATIVE-FREE

Refresh
OPTIVE®
ADVANCED
Lubricant Eye Drops

with Hydrocell®

Triple-Action Relief

30 Vials
0.01 fl oz (0.4 mL) each Sterile

NDC 0023-4491-30 PRESERVATIVE-FREE Refresh OPTIVE® ADVANCED Lubricant Eye Drops with Hydrocell® Triple-Action Relief 30 Vials 0.01 fl oz (0.4 mL) each SterileNDC 0023-4491-30 PRESERVATIVE-FREE Refresh OPTIVE® ADVANCED Lubricant Eye Drops with Hydrocell® Triple-Action Relief 30 Vials 0.01 fl oz (0.4 mL) each Sterile

     

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionPSN11
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCD11
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSY11

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-4491-05REFRESH OPTIVE Advanced0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411
0023-4491-05REFRESH OPTIVE Advanced5 in 1 CARTONSOLUTION/ DROPS511
0023-4491-30REFRESH OPTIVE Advanced30 in 1 CARTONSOLUTION/ DROPS3011
0023-4491-30REFRESH OPTIVE Advanced0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-4491-30EA - Each0023-449195847a4a-09ea-46e7-8122-8f177a6123aa12013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS3112
glycerinACTIVE INGREDIENTPDC6A3C0OX2
polysorbate 80ACTIVE INGREDIENT6OZP39ZG8H2
carboxymethylcelluloseACTIVE MOIETY05JZI7B19X2
glycerinACTIVE MOIETYPDC6A3C0OX2
polysorbate 80ACTIVE MOIETY6OZP39ZG8H2
boric acidINACTIVE INGREDIENTR57ZHV85D42
carbomer copolymer type AINACTIVE INGREDIENT71DD5V995L2
castor oilINACTIVE INGREDIENTD5340Y2I9G2
erythritolINACTIVE INGREDIENTRA96B954X62
levocarnitineINACTIVE INGREDIENT0G389FZZ9M2
sodium hydroxideINACTIVE INGREDIENT55X04QC32I2
waterINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-44910023-4491-05, 0023-4491-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
carboxymethylcellulose sodiumK679OBS311ACTIB
glycerinPDC6A3C0OXACTIB
polysorbate 806OZP39ZG8HACTIB
boric acidR57ZHV85D4IACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
castor oilD5340Y2I9GIACT
erythritolRA96B954X6IACT
levocarnitine0G389FZZ9MIACT
water059QF0KO0RIACT
sodium hydroxide55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102022-09-15full-release2026-06-01 00:40:42

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
castor oilCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii+route
3 equally ranked IID candidates
carbomer copolymer type ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LEMULSION / OPHTHALMIC0.05 %w/vExact identifier — unii+route
3 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carbomer copolymer type ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LEMULSION / OPHTHALMIC0.05 %w/vExact identifier — unii+route
3 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carbomer copolymer type ACARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LEMULSION / OPHTHALMIC0.05 %w/vExact identifier — unii+route
3 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
3 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii+route
3 equally ranked IID candidates
castor oilCASTOR OILD5340Y2I9GEMULSION / OPHTHALMIC32 mgExact identifier — unii+route
3 equally ranked IID candidates

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 AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
ndc (package): 0023-4491-05
ndc (package): 0023-4491-30
ndc (product): 0023-4491
ndc11 (package): 00023449105
ndc11 (package): 00023449130
spl id: 74f3d119-623c-4bd1-a5aa-e92db774f116
spl set id: ebd0839e-2e1d-4e0e-986c-19f1f5c76358

Reported adverse events (FAERS/openFDA)#

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