FDA.reportPublic FDA data

Refresh Digital PF

Manufacturer
Allergan, Inc.
Effective date
2022-11-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:04:24

Label at a glance#

ProductRefresh Digital 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

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#

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

OTC - STOP USE SECTION

if 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

PhonePhone 1.800.678.1605

refreshbrand.com

v1.0DFL6954

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0023-6954-30

Refresh®
DIGITAL PF
Lubricant Eye Drops
For Eye Dryness
with   HydroCell ™
Fast-acting Relief
That Soothes Your Eyes
30 Vials (0.01 fl oz (0.4 mL) each Sterile

Principal Display Panel NDC 0023-6954-30 Refresh® DIGITAL PF Lubricant Eye Drops For Eye Dryness with HydroCell™ Fast-acting Relief That Soothes Your Eyes 30 Vials (0.01 fl oz (...Principal Display Panel NDC 0023-6954-30 Refresh® DIGITAL PF Lubricant Eye Drops For Eye Dryness with HydroCell™ Fast-acting Relief That Soothes Your Eyes 30 Vials (0.01 fl oz (...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionPSN3
1241471carboxymethylcellulose sodium 5 MG/ML / glycerin 10 MG/ML / polysorbate 80 5 MG/ML Ophthalmic SolutionSCD3
1241471carboxymethylcellulose sodium 0.5 % / glycerin 1 % / polysorbate 80 0.5 % Ophthalmic SolutionSY3

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
0023-6954-05Refresh Digital PF.40 mL in 1 VIAL, PLASTICSOLUTION/ DROPS.403
0023-6954-05Refresh Digital PF1 in 1 CARTONSOLUTION/ DROPS13
0023-6954-30Refresh Digital PF0.4 mL in 1 VIAL, PLASTICSOLUTION/ DROPS0.43
0023-6954-30Refresh Digital PF30 in 1 CARTONSOLUTION/ DROPS303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-6954REFRESH DIGITAL PF (CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80) SOLUTION/ DROPS [ALLERGAN, INC.]3Current NDC, Legacy NDC, 4 package rows20231215_97e83e68-6374-4df4-93f6-d707fc32748d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-6954-30EA - Each0023-6954c93967c6-6e9f-4e8c-b4b0-8967188dd5aa12020-09-14

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
0023-69540023-6954-30, 0023-6954-05

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 A71DD5V995LIACT
CASTOR OILD5340Y2I9GIACT
ERYTHRITOLRA96B954X6IACT
LEVOCARNITINE0G389FZZ9MIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

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 Digital PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.97e83e68-6374-4df4-93f6-d707fc32748d2022-11-28WarningsExact identifier
ndc (package): 0023-6954-30
ndc (package): 0023-6954-05
ndc (product): 0023-6954
ndc11 (package): 00023695405
ndc11 (package): 00023695430
spl id: 0702ebf0-06fb-44a1-ba8b-21c00c4a288d
spl set id: 97e83e68-6374-4df4-93f6-d707fc32748d

Reported adverse events (FAERS/openFDA)#

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