FDA.reportPublic FDA data

Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops

Manufacturer
Rugby Laboratories | KC Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:29:34

Label at a glance#

ProductRugby Carboxymethylcellulose Sodium 0.5% Eye Drops
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM
Label structure10 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 to 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Carboxymethylcellulose sodium 0.5%

Purpose

OTC - PURPOSE SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

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 you experience

OTC - STOP USE SECTION

  • 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

instill 1 to 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

store at 15°-25°C (59°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, calcium chloride hydrate (dihydrate), hydrochloric acid**, magnesium chloride, potassium chloride, sodium borate, sodium chloride, sodium hydroxide**, water for injection

**May contain these ingredients to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 15mLRugby Carboxymethylcellulose Sodium 0.5% Eye Drops 15mL

Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 2-15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops 2-15mLRugby Carboxymethylcellulose Sodium 0.5% Eye Drops 2-15mL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionPSN4
1188426carboxymethylcellulose sodium 5 MG/ML Ophthalmic SolutionSCD4
1188426carboxymethylcellulose sodium 0.5 % Ophthalmic SolutionSY4
1188426carboxymethylcellulose sodium 0.5 GM per 100 ML Ophthalmic SolutionSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130305361386351GTIN-13: 0305361386351
EAN-13: 0305361386351
GTIN-12: 305361386351
UPC-A: 305361386351
GTIN storage (14 digits): 00305361386351		KC - Rugby Carboxymethylcellulose Sodium Eye Drops (15mL twin pk).jpg
BarcodeEAN-130305361386948GTIN-13: 0305361386948
EAN-13: 0305361386948
GTIN-12: 305361386948
UPC-A: 305361386948
GTIN storage (14 digits): 00305361386948		KC - Rugby Carboxymethylcellulose sodium Eye Drops 15mL.jpg

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
0536-1386-35Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops2 in 1 BOXSOLUTION/ DROPS24
0536-1386-35Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
0536-1386-94Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
0536-1386-94Rugby Carboxymethylcellulose Sodium 0.5% Eye Drops1 in 1 BOXSOLUTION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1386-35ML - Milliliter0536-13863c291b67-0f2e-468a-a899-06993ef3f1b712023-09-05
0536-1386-94ML - Milliliter0536-1386f24f0af7-612d-4b29-b657-4cea856a8ae312023-09-05

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
0536-13860536-1386-94, 0536-1386-35

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
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
HYDROCHLORIC ACIDQTT17582CBIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CHLORIDE451W47IQ8XIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311ACTIB
SODIUM BORATE91MBZ8H3QOIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT

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
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
ndc (package): 0536-1386-94
ndc (package): 0536-1386-35
ndc (product): 0536-1386
ndc11 (package): 00536138635
ndc11 (package): 00536138694
spl id: 47353b72-f563-247f-e063-6294a90aedee
spl set id: fb84fc0b-9a62-812a-e053-6394a90aba0a

Reported adverse events (FAERS/openFDA)#

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