FDA.reportPublic FDA data

REFRESH OPTIVE Drops

Manufacturer
Allergan, Inc.
Effective date
2025-09-15
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
daily-update
Hydrated at
2026-06-11 05:10:24

Label at a glance#

ProductREFRESH OPTIVE Drops
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN
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

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 1%

Glycerin 0.9%

Purpose

OTC - PURPOSE SECTION

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 or becomes cloudy, 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

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 FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; PURITE® (stabilized oxychloro complex); sodium borate decahydrate; and sodium citrate dihydrate.

Questions or comments?

OTC - QUESTIONS SECTION

1.800.678.1605

refresheyedrops.com

v2.0DFL5459

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-5459-10
Refresh
Optive ®
GEL DROPS
Lubricant Eye Gel
Extended Relief

Lasting comfort
Day or Night for Dry Eyes
0.33 fl oz (10 mL) Sterile

PRINCIPAL DISPLAY PANEL NDC 0023-5459-10 Refresh Optive® GEL DROPS Lubricant Eye Gel Extended Relief Lasting comfort Day or Night for Dry Eyes 0.33 fl oz (10 mL) SterilePRINCIPAL DISPLAY PANEL NDC 0023-5459-10 Refresh Optive® GEL DROPS Lubricant Eye Gel Extended Relief Lasting comfort Day or Night for Dry Eyes 0.33 fl oz (10 mL) Sterile

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300235459100GTIN-13: 0300235459100
EAN-13: 0300235459100
GTIN-12: 300235459100
UPC-A: 300235459100
GTIN storage (14 digits): 00300235459100		refresh-optive-gel-drops-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-5459-10ML - Milliliter0023-5459c0a586db-2a19-4768-9634-ac88eb04945112016-02-04

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-54590023-5459-10, 0023-5459-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
GLYCERINPDC6A3C0OXACTIB
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
ERYTHRITOLRA96B954X6IACT
LEVOCARNITINE0G389FZZ9MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORITEG538EBV4VFIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
112025-09-15full-release2026-06-01 01:15:49

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 DropsCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.80275190-d717-40ea-905b-5c8fbe986eac2025-09-15WarningsExact identifier
ndc (package): 0023-5459-02
ndc (package): 0023-5459-10
ndc (product): 0023-5459
ndc11 (package): 00023545910
ndc11 (package): 00023545902
spl id: aac13975-5fb6-4871-bd4f-30467f13a9ba
spl set id: 80275190-d717-40ea-905b-5c8fbe986eac

Reported adverse events (FAERS/openFDA)#

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