FDA.reportPublic FDA data

Refresh Tears Lubricant Eye Drops

Manufacturer
Navajo Manufacturing Company Inc. | Allergan, Inc.
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 00:22:28

Label at a glance#

ProductRefresh Tears Lubricant
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
Label structure11 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.

Storage and handling

Use only if the imprinted seal around the bottle neck is intact and not damaged. Use before expiration date marked on container. Store at 59° - 86° F (15° - 30 C) RETAIN THIS PACKAGING FOR FUTURE REFERENCE.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

Purpose

OTC - PURPOSE SECTION

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

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

Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

STORAGE AND HANDLING SECTION

  • Use only if the imprinted seal around the bottle neck is intact and not damaged.
  • Use before expiration date marked on container.
  • Store at 59° - 86° F (15° - 30 C)
  • RETAIN THIS PACKAGING FOR FUTURE REFERENCE.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; PURITE ® (stablilized oxychloro complex); sodium borate; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1.800.433.8871, M-F 6 AM - 4:30 PM Pacific Time

refreshbrand.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refresh TearsRefresh Tears

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN14
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD14
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY14
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY14

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67751-130-012023-03-16C16284748780-1f386c64a-303a-0266-e053-dadaa90a7c1aRefresh Tears Lubricant Eye Drops
67751-130-012023-01-30C16284748780-1f386c64a-303a-0266-e053-dadaa90a7c1aRefresh Tears Lubricant Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67751-130-01Refresh Tears Lubricant3 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS314

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67751-130REFRESH TEARS LUBRICANT (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [NAVAJO MANUFACTURING COMPANY INC.]14Legacy NDC, 1 package rows20241004_3b94f67c-d675-4e16-846a-3ca39b0405e0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0798-01ML - Milliliter0023-079862c6f21f-4516-4eea-ba68-d29b027aea0412012-07-24
0023-0798-02ML - Milliliter0023-079822f1d5bd-fff4-45c7-a80b-b75da37562a112012-07-24
0023-0798-15ML - Milliliter0023-0798a409ce19-82da-4f27-91e4-8c86819535dc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBOXYMETHYLCELLULOSE SODIUMACTIVE INGREDIENTK679OBS31110
CARBOXYMETHYLCELLULOSEACTIVE MOIETY05JZI7B19X10
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D410
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M10
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB10
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O10
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I1010
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QO10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X10
SODIUM CHLORITEINACTIVE INGREDIENTG538EBV4VF10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I10
WATERINACTIVE INGREDIENT059QF0KO0R10

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
67751-13067751-130-01
0023-0798

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
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORITEG538EBV4VFIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB

Source Document#

Source XML

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 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii+route+dosage form
BORIC ACIDBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii+route+dosage form
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION/ DROPS / OPHTHALMIC55 mgExact identifier — unii+route+dosage form
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
SODIUM BORATESODIUM BORATE91MBZ8H3QOSOLUTION/ DROPS / OPHTHALMIC1.1 %w/vExact identifier — unii+route+dosage form
SODIUM CHLORITESODIUM CHLORITEG538EBV4VFSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii+route+dosage form

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
584f6fae-655c-44d6-e063-6294a90abb0a3b94f67c-d675-4e16-846a-3ca39b0405e02026-08-05WarningsExact identifier
spl set id: 3b94f67c-d675-4e16-846a-3ca39b0405e0
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
ndc (product): 0023-0798

Reported adverse events (FAERS/openFDA)#

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