FDA.reportPublic FDA data

Carboxymethylcellulose sodium

Manufacturer
PROMED EXPORTS PRIVATE LIMITED
Effective date
2009-08-27
Label type
Human OTC Drug Label
Version
1
Source
full-release
Hydrated at
2026-05-31 22:22:37

Label at a glance#

ProductCarboxymethylcellulose sodium
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
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. If used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor’s instructions.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium (CMC) 0.5% ............... 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.
  • Do not use if solution changes color or becomes cloudy.

STOP USE AND ASK A DOCTOR

OTC - ASK DOCTOR 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

SPL UNCLASSIFIED SECTION

To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.

If used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor’s instructions.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • Use only if single-use container is intact.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Calcium chloride; magnesium chloride; potassium chloride; purified water; sodium chloride; and sodium lactate. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 30 Sterile Single Use Containers

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


CARBOXYMETHYLCELLULOSE SODIUM (CMC) 0.5%
LUBRICANT EYE DROPS
 
carboxymethylcellulose sodium
carboxymethylcellulose sodium
 

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN1
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD1
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY1
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY1

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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
49668-001-012019-10-21C16284748780-1956f9ecf-d5d5-621f-e053-dbdaa90a74ad3aba460a-1912-4794-a317-f477af962b40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49668-001-01Carboxymethylcellulose sodium0.4 mL in 1 VIAL, SINGLE-DOSESOLUTION0.41
49668-001-01Carboxymethylcellulose sodium30 in 1 CONTAINERSOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49668-001CARBOXYMETHYLCELLULOSE SODIUM SOLUTION [PROMED EXPORTS PRIVATE LIMITED]1Legacy NDC, 2 package rows20091001_3aba460a-1912-4794-a317-f477af962b40.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBOXYMETHYLCELLULOSE SODIUMACTIVE INGREDIENTK679OBS3111
CARBOXYMETHYLCELLULOSEACTIVE MOIETY05JZI7B19X1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5M1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CB1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I101
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QT1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49668-00149668-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
CALCIUM CHLORIDEM4I0D6VV5MIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM LACTATETU7HW0W0QTIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT

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 9 · 504 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBCAPSULE, LIQUID FILLED / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INTRAVENOUS4 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
POTASSIUM CHLORIDEPOTASSIUM CHLORIDE660YQ98I10SOLUTION / INTRAOCULAR38 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAVENOUS2.78 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / PERINEURALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBTABLET, EXTENDED RELEASE / ORAL24 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / PARENTERAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRATUMORADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRALESIONALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBARACHNOIDADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARYADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, SUSPENSION / INTRAVENOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSUSPENSION, EXTENDED RELEASE / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBTABLET, FILM COATED / ORALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRAVENOUS720 mgExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISYRUP / ORAL71 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVITREAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISUSPENSION/ DROPS / OPHTHALMICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR45 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INFILTRATION0.37 %w/vExact identifier — unii candidate
148 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION / INFILTRATION0.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INFILTRATION3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSOLUTION / INTRAVASCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, EMULSION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XDROPS / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR360 mgExact identifier — unii candidate
134 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTION, SUSPENSION / INTRAVITREAL0.05 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
CALCIUM CHLORIDECALCIUM CHLORIDEM4I0D6VV5MINJECTABLE, LIPOSOMAL / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
16 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / INTRATHECAL176 mgExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / URETHRALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICAPSULE, LIQUID FILLED / ORAL1.5 mgExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ENDOTRACHEAL7.6 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IINJECTION / SUBCONJUNCTIVALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION, POWDER, FOR SOLUTION / INTRADERMALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBINJECTION / INTRASPINALADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBLIQUID / INTRAMUSCULARADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAVENOUS6320 mgExact identifier — unii candidate
134 equally ranked IID candidates
HYDROCHLORIC ACIDHYDROCHLORIC ACIDQTT17582CBSPRAY, METERED / RESPIRATORY (INHALATION)ADJ PHExact identifier — unii candidate
148 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR226 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 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
3aba460a-1912-4794-a317-f477af962b403aba460a-1912-4794-a317-f477af962b402009-08-27WarningsExact identifier
spl id: 3aba460a-1912-4794-a317-f477af962b40
spl set id: 3aba460a-1912-4794-a317-f477af962b40

Reported adverse events (FAERS/openFDA)#

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