FDA.reportPublic FDA data

Lubricating Tears (CMC Drops)

Manufacturer
Reliable 1 Laboritories LLC
Effective date
2025-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:54:54

Label at a glance#

ProductLubricating Tears
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Label structure13 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

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Carboxymethylcellulose sodium 0.5%

OTC - PURPOSE SECTION

Purpose

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.
  • Retain outer carton for full product drug facts

Do Not Use

OTC - DO NOT USE SECTION

  • If solution changes color or becomes cloudy.

When using this product

OTC - WHEN USING SECTION

  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

  • you experience eye pain, changes in vision
  • continued redness or irritation of the eye
  • 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. 1-800-222-1222

OTHER INFORMATION

OTHER SAFETY INFORMATION

OTHER INFORMATION

Store at room temperature 15°-30°C (59°-86°F).
Keep tightly closed

Questions or comments?

OTHER SAFETY INFORMATION

Questions or comments?

1-516-341-0666

8:30AM – 4:30PM

Monday – Friday

Directions

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

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

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.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lubricating Tears

NDC 69618-076-55
Lubricant Eye Drops

Compare to Refresh Tears® active ingredient


Soothing, moisturizing relief of dry eyes
Sterile

0.5 fl oz (15 mL)

CMC bottle labelCMC bottle label

CMC carton labelCMC carton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN2
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD2
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY2
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-076-55Lubricating Tears1 in 1 CARTONSOLUTION/ DROPS12
69618-076-55Lubricating Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-076LUBRICATING TEARS (CARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTION) SOLUTION/ DROPS [RELIABLE 1 LABORITORIES LLC]2Current NDC, 2 package rows20250213_29023a57-eba3-4241-e063-6294a90a7048.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-076-55ML - Milliliter69618-0763d479db1-750a-4c8f-aad6-7001b66ec15b12025-01-14

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
69618-07669618-076-55

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
SODIUM CHLORIDE451W47IQ8XIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311ACTIB
CALCIUM CHLORIDEM4I0D6VV5MIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORITEG538EBV4VFIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM BORATE91MBZ8H3QOIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT

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
Lubricating TearsCARBOXYMETHYLCELLULOSE SODIUM 0.5% SOLUTIONReliable 1 Laboritories LLC29023a57-eba3-4241-e063-6294a90a70482025-01-15WarningsExact identifier
ndc (package): 69618-076-55
ndc (product): 69618-076
ndc11 (package): 69618007655
spl id: 2bc85d47-d66a-d2ff-e063-6394a90ab04a
spl set id: 29023a57-eba3-4241-e063-6294a90a7048

Reported adverse events (FAERS/openFDA)#

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