FDA.reportPublic FDA data

Refresh Relieva PF Xtra

Manufacturer
Allergan, Inc.
Effective date
2025-09-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:57:01

Label at a glance#

ProductRefresh Relieva PF Xtra
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

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 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

  • 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; calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium borate decahydrate; sodium citrate dihydrate; sodium hyaluronate, 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

v2.0DFL3782

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-3782-10


PRESERVATIVE-FREE
Refresh®
RELIEVA® PF
Xtra
Lubricant Eye Drops
With
HydroCell®
Fast-Acting Relief
Hydrates & Protects
Dry, Sensitive Eyes
0.33 fl oz (10 mL) Sterile

PRINCIPAL DISPLAY PANEL NDC 0023-3782-10 PRESERVATIVE-FREE Refresh® RELIEVA® PF Xtra Lubricant Eye Drops With HydroCell® Fast-Acting Relief Hydrates & Protects Dry, Sensitive Ey...PRINCIPAL DISPLAY PANEL NDC 0023-3782-10 PRESERVATIVE-FREE Refresh® RELIEVA® PF Xtra Lubricant Eye Drops With HydroCell® Fast-Acting Relief Hydrates & Protects Dry, Sensitive Ey...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionPSN5
1100650carboxymethylcellulose sodium 5 MG/ML / glycerin 9 MG/ML Ophthalmic SolutionSCD5
1100650carboxymethylcellulose sodium 0.5 % / glycerin 0.9 % Ophthalmic SolutionSY5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300233782101GTIN-13: 0300233782101
EAN-13: 0300233782101
GTIN-12: 300233782101
UPC-A: 300233782101
GTIN storage (14 digits): 00300233782101		refresh-relieva-pf-xtra-02.jpg

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
4585a4fb-0028-3d95-020c-9b1c40bf15e0Product name120140508
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-3782-10Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15
0023-3782-10Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-20Refresh Relieva PF Xtra2 in 1 CARTONSOLUTION/ DROPS25
0023-3782-20Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-35Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15
0023-3782-35Refresh Relieva PF Xtra10 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS105
0023-3782-50Refresh Relieva PF Xtra3.5 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS3.55
0023-3782-50Refresh Relieva PF Xtra1 in 1 CARTONSOLUTION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-3782-10ML - Milliliter0023-37823127801c-16b2-4bd1-a846-8eb925ff18dc12024-05-16
0023-3782-20ML - Milliliter0023-378243f3c3fc-2482-4e42-827c-a4aa114c177012025-11-13

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
0023-37820023-3782-10, 0023-3782-35, 0023-3782-50, 0023-3782-20

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
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
ERYTHRITOLRA96B954X6IACT
LEVOCARNITINE0G389FZZ9MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
HYALURONATE SODIUMYSE9PPT4THIACT
TREHALOSEB8WCK70T7IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-09-15monthly-update2026-06-03 17:39:55
22024-03-01full-release2026-06-01 00:13:26

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 Relieva PF XtraCARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.b51b8a75-8faa-430f-8f7e-ee58d3d13f2e2025-09-15WarningsExact identifier
ndc (package): 0023-3782-10
ndc (package): 0023-3782-20
ndc (package): 0023-3782-35
ndc (package): 0023-3782-50
ndc (product): 0023-3782
ndc11 (package): 00023378250
ndc11 (package): 00023378220
ndc11 (package): 00023378210
ndc11 (package): 00023378235
spl id: b6ddb19b-f29a-4a65-ac95-33420c2bd4bf
spl set id: b51b8a75-8faa-430f-8f7e-ee58d3d13f2e

Reported adverse events (FAERS/openFDA)#

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