TheraTears Lubricant

Manufacturer
MEDTECH PRODUCTS INC
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:40:17

Label at a glance#

ProductTheraTears Lubricant
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

As a lubricant to relieve dryness of the eye. As a protectant against further irritation of the eye. For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Dosage and administration

To open,  twist  tab completely off. Instill 1 or 2 drops in the affected eye(s) as needed.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

THERATEARS LUBRICANT- carboxymethylcellulose sodium solution/ drops 
Medtech Products Inc., a Prestige Consumer Healthcare company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Drug Facts

Active ingredient (In each unit dose)

OTC - ACTIVE INGREDIENT SECTION

Sodium Carboxymethylcellulose 0.25%

Purpose

OTC - PURPOSE SECTION

Eye lubricant

Uses

INDICATIONS & USAGE SECTION

  • As a lubricant to relieve dryness of the eye.
  • As a protectant against further irritation of the eye.
  • For temporary relief of burning, irritation, and discomfort including exposure to wind or sun.

Warnings

WARNINGS SECTION

For external use only

  • To avoid contamination do not touch tip of opened container to any surface. Do not reuse. Once opened discard. Use individual vials within 90 days of opening foil pouch.
  • This product contains no preservatives. Any solution not used immediately after opening should be discarded. Re-use of this single-use product may lead to inflammation of the eye and/or discomfort, based on potential contamination during handling.

Do not use

OTC - DO NOT USE SECTION

  • If solution changes color or becomes cloudy.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • You experience eye pain, changes in vision, continued redness or irritation.
  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • To open, twist tab completely off.
  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other information

OTHER SAFETY INFORMATION

  • Store between 15-25 C (59-77F)
  • Do not touch unit-dose tip to eye.

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid , calcium chloride, magnesium chloride, potassium chloride, sodium bicarbonate, sodium borate, sodium chloride, sodium phosphate, water

Questions and comments?

OTC - QUESTIONS SECTION

1-800-579-8327

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRESERVATIVE FREE

thera

tears®

THERAPY FOR YOUR EYES TM

dry eye therapy

LUBRICANT

EYE DROPS

IMMEDIATE

LONG LASTING

RELIEF

30  STERILE Single-Use Vials

0.60 FL OZ (18.0mL) TOTAL

Principal Display Panel PRESERVATIVE FREE thera tears® THERAPY FOR YOUR EYES TM dry eye therapy LUBRICANT EYE DROPS IMMEDIATE LONG LASTING RELIEF 30 STERILE Single-Use Vials 0.6...Principal Display Panel PRESERVATIVE FREE thera tears® THERAPY FOR YOUR EYES TM dry eye therapy LUBRICANT EYE DROPS IMMEDIATE LONG LASTING RELIEF 30 STERILE Single-Use Vials 0.6...

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionPSN11
2106821TheraTears 0.25 % Ophthalmic SolutionPSN11
2106821carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic Solution [TheraTears]SBD11
1547948carboxymethylcellulose sodium 2.5 MG/ML Ophthalmic SolutionSCD11
1547948carboxymethylcellulose sodium 0.25 % Ophthalmic SolutionSY11
2106821TheraTears 0.25 % Ophthalmic SolutionSY11
2106821TheraTears 2.5 MG/ML Ophthalmic SolutionSY11

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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
58790-000-00TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-00TheraTears Lubricant5 in 1 POUCHSOLUTION/ DROPS511
58790-000-20TheraTears Lubricant5 in 1 CARTONSOLUTION/ DROPS511
58790-000-20TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411
58790-000-24TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-24TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411
58790-000-30TheraTears Lubricant6 in 1 CARTONSOLUTION/ DROPS611
58790-000-30TheraTears Lubricant5 in 1 POUCHSOLUTION/ DROPS511
58790-000-32TheraTears Lubricant8 in 1 CARTONSOLUTION/ DROPS811
58790-000-32TheraTears Lubricant4 in 1 POUCHSOLUTION/ DROPS411

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58790-000-30EA - Each58790-0007e5d4351-c5aa-44ab-a75d-23acb21914a012019-10-07
58790-000-32EA - Each58790-00005a92925-dc86-4bff-8432-79ef3b75117912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
carboxymethylcellulose sodiumACTIVE INGREDIENTK679OBS3111
carboxymethylcelluloseACTIVE MOIETY05JZI7B19X1
boric acidINACTIVE INGREDIENTR57ZHV85D41
calcium chlorideINACTIVE INGREDIENTM4I0D6VV5M1
magnesium chlorideINACTIVE INGREDIENT02F3473H9O1
potassium chlorideINACTIVE INGREDIENT660YQ98I101
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QO1
sodium borateINACTIVE INGREDIENT91MBZ8H3QO1
sodium chlorideINACTIVE INGREDIENT451W47IQ8X1
sodium phosphateINACTIVE INGREDIENTSE337SVY371
waterINACTIVE INGREDIENT059QF0KO0R1

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
58790-00058790-000-32, 58790-000-24, 58790-000-20, 58790-000-30, 58790-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-10-25full-release2026-06-01 00:43:19

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 5 · 252 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOPOWDER, FOR SOLUTION / ORAL1250 mg/100mlExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS3059 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRATHECAL0.05 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAVITREAL0.18 %w/vExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION / INTRAMUSCULAR175 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, CHEWABLE / ORAL140 mgExact identifier — unii candidate
204 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
204 equally ranked IID candidates
potassium chloridePOTASSIUM CHLORIDE660YQ98I10SOLUTION/ DROPS / OPHTHALMIC0.14 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, SOLUTION / INTRAVENOUS52 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EXTENDED RELEASE / ORAL81 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
204 equally ranked IID candidates
calcium chlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / BUCCAL42 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOCAPSULE / ORAL320 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
204 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / SUBLINGUAL6 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOGUM, CHEWING / BUCCAL240 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37SOLUTION / OPHTHALMIC0.81 %w/wExact identifier — unii+route
12 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, FILM COATED / ORAL86 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOFILM, SOLUBLE / ORAL2 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, EFFERVESCENT / ORAL57600 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINSERT / VAGINAL129 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS3219 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOLOZENGE / ORAL100 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOGRANULE, EFFERVESCENT / ORAL267 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SOLUTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOTABLET, ORALLY DISINTEGRATING / ORAL107 mgExact identifier — unii candidate
204 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii candidate
204 equally ranked IID candidates
sodium phosphateSODIUM PHOSPHATESE337SVY37SUSPENSION / OPHTHALMIC0.2 %w/wExact identifier — unii+route
12 equally ranked IID candidates
boric acidBORIC ACIDR57ZHV85D4SOLUTION/ DROPS / OPHTHALMIC48 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
calcium chlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
calcium chlorideCALCIUM CHLORIDEM4I0D6VV5MSOLUTION/ DROPS / OPHTHALMIC0.02 %w/vExact identifier — unii+route+dosage form
6 equally ranked IID candidates
sodium bicarbonateSODIUM BICARBONATE8MDF5V39QOINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS160 mgExact identifier — unii candidate
204 equally ranked IID candidates

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
TheraTears LubricantCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC797b0394-2f0f-4733-8d20-ec5bdf3e085d2025-10-23WarningsExact identifier
ndc (package): 58790-000-20
ndc (package): 58790-000-24
ndc (package): 58790-000-32
ndc (package): 58790-000-00
ndc (package): 58790-000-30
ndc (product): 58790-000
ndc11 (package): 58790000032
ndc11 (package): 58790000024
ndc11 (package): 58790000000
ndc11 (package): 58790000020
ndc11 (package): 58790000030
spl id: 39e5aaf6-e4a0-4167-b458-f22af5906ddc
spl set id: 797b0394-2f0f-4733-8d20-ec5bdf3e085d

Reported adverse events (FAERS/openFDA)#

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