FDA.reportPublic FDA data

Refresh Optive

Manufacturer
Allergan, Inc.
Effective date
2025-08-22
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
weekly-update
Hydrated at
2026-07-17 21:41:47

Label at a glance#

ProductRefresh Optive
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

To open, TWIST AND PULL TAB TO REMOVE.  Instill 1 or 2 drops in the affected eye(s) as needed and discard container. *Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

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. Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.
  • 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

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container. *Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

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; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; and sodium citrate dihydrate.

Questions or comments?

OTC - QUESTIONS SECTION

PhonePhone  1.800.678.1605

refresheyedrops.com

v2.0DFL3416

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-3416-30
PRESERVATIVE-FREE
Refresh
OPTIVE ®
Lubricant Eye Drops
Dual-Action Relief
For Dry, Sensitive Eyes 
30 Vials 0.01 fl oz (0.4 mL) each Sterile

PRINCIPAL DISPLAY PANEL NDC 0023-3416-30 Preservative-free Refresh Optive® Lubricant Eye Drops Dual-Action Relief For Dry, Sensitive Eyes 30 Vials 0.01 fl oz (0.4 mL) each SterilePRINCIPAL DISPLAY PANEL NDC 0023-3416-30 Preservative-free Refresh Optive® Lubricant Eye Drops Dual-Action Relief For Dry, Sensitive Eyes 30 Vials 0.01 fl oz (0.4 mL) each Sterile

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
08c722ec-780f-bb7b-8f14-3d4f7bf0e098Product name220240205
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
e2f276e5-439f-b432-b5e5-b0cfa993da69Product name320220609
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3416-30EA - Each0023-3416ca072ca6-67cf-44a4-b188-11050f04b3cd12012-07-24
0023-3416-60EA - Each0023-3416c282ce4e-bb1b-4fc0-b24d-c564bbb7e83012013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Carboxymethylcellulose SodiumACTIVE INGREDIENTK679OBS3113
GlycerinACTIVE INGREDIENTPDC6A3C0OX3
CarboxymethylcelluloseACTIVE MOIETY05JZI7B19X3
GlycerinACTIVE MOIETYPDC6A3C0OX3
Boric AcidINACTIVE INGREDIENTR57ZHV85D43
Calcium ChlorideINACTIVE INGREDIENTM4I0D6VV5M3
ErythritolINACTIVE INGREDIENTRA96B954X63
LevocarnitineINACTIVE INGREDIENT0G389FZZ9M3
Magnesium ChlorideINACTIVE INGREDIENT02F3473H9O3
potassium chlorideINACTIVE INGREDIENT660YQ98I103
sodium borateINACTIVE INGREDIENT91MBZ8H3QO3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95K3
waterINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0023-34160023-3416-05, 0023-3416-30, 0023-3416-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Carboxymethylcellulose SodiumK679OBS311ACTIB
GlycerinPDC6A3C0OXACTIB
Boric AcidR57ZHV85D4IACT
Calcium ChlorideM4I0D6VV5MIACT
ErythritolRA96B954X6IACT
Levocarnitine0G389FZZ9MIACT
Magnesium Chloride02F3473H9OIACT
potassium chloride660YQ98I10IACT
water059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
trisodium citrate dihydrateB22547B95KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-08-22full-release2026-06-01 01:31:41

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 · 24 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Calcium ChlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
trisodium citrate dihydrateTRISODIUM CITRATE DIHYDRATEB22547B95KSOLUTION/ DROPS / OPHTHALMIC1 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
sodium borateSODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Magnesium ChlorideMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
4 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 OptiveCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINAllergan, Inc.37e99aa8-02d6-4efb-a862-90bc7fcd5ca52025-08-22WarningsExact identifier
ndc (package): 0023-3416-05
ndc (package): 0023-3416-60
ndc (package): 0023-3416-30
ndc (product): 0023-3416
ndc11 (package): 00023341660
ndc11 (package): 00023341605
ndc11 (package): 00023341630
spl id: 8e11bd05-1d8c-4abe-80d0-440cae2323b5
spl set id: 37e99aa8-02d6-4efb-a862-90bc7fcd5ca5

Reported adverse events (FAERS/openFDA)#

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