FDA.reportPublic FDA data

Carboxymethylcellulose Sodium Ophthalmic Gel 1% Lubricant Eye Gel

Manufacturer
AvPAK
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:09:33

Label at a glance#

Productcarboxymethylcellulose sodium
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
Label structure9 sections

Dosage and administration

Shake well before use. Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 1%

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 use in the eyes 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.

OTC - STOP USE SECTION

Stop use and ask a doctor 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use.

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

Other information

SPL UNCLASSIFIED SECTION

  • Do Not Use if imprinted seal on cap is torn, broken or missing.
  • Discard 90 days after opening.
  • Store at room temperature 15°-30°C (59°-86°F).
  • Retain outer carton for full product drug information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Boric acid, calcium chloride, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride. Stabilized Oxychloro Complex 2.5%. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

1-855-361-3993

Distributed by:
AvKARE

Pulaski, TN 38478

Rev. 09/2020 AV 09/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tutu

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
579907carboxymethylcellulose sodium 1 % Ophthalmic GelPSN6
579907carboxymethylcellulose sodium 0.01 MG/MG Ophthalmic GelSCD6
579907carboxymethylcellulose sodium 1 % Ophthalmic GelSY6

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
50268-066-152026-01-29C16284748780-149896155-a9be-586f-e063-e6dba90add90Carboxymethylcellulose Sodium Ophthalmic Gel 1% Lubricant Eye Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50268-066-15carboxymethylcellulose sodium1 in 1 CARTONGEL16
50268-066-15carboxymethylcellulose sodium15 mL in 1 BOTTLE, DROPPERGEL156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-066CARBOXYMETHYLCELLULOSE SODIUM GEL [AVPAK]6Legacy NDC, 2 package rows20240308_b469f1c4-bd94-6f50-e053-2995a90a452f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-066-15ML - Milliliter50268-066e3038150-ce44-453d-99f8-e81639f3c25e12022-02-07

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50268-06650268-066-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
BORIC ACIDR57ZHV85D4IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB

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
130364f2-4379-9324-e063-6294a90a9747b469f1c4-bd94-6f50-e053-2995a90a452f2024-03-06WarningsExact identifier
spl id: 130364f2-4379-9324-e063-6294a90a9747
spl set id: b469f1c4-bd94-6f50-e053-2995a90a452f

Reported adverse events (FAERS/openFDA)#

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