FDA.reportPublic FDA data

Major Lubricating Eye Drops

Manufacturer
Harvard Drug Group L L C | KC Pharmaceuticals, Inc. | Unimed
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:17:30

Label at a glance#

ProductMajor Lubricating Eye Drops
Active ingredientCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
Label structure10 sections

Indications and uses

for the temporary relief of burning, irritation, and discomfort due to dryness of the eyes 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 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 eyes 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 this product if

OTC - DO NOT USE SECTION

  • solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • do not reuse
  • once opened, discard
  • to avoid contamination, do not touch tip of container to any surface
  • do not touch unit-dose tip to eye

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you experience eye pain
  • changes in vision occur
  • redness or irritation of the eye continues
  • redness or irritation of the eye worsens or persists for more than 72 hours

Keep out of the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

DOSAGE & ADMINISTRATION 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

OTHER SAFETY INFORMATION

  • store at 15°-25°C (59°-77°)
  • use only if single use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

INACTIVE INGREDIENT SECTION

calcium chloride, **hydrochloric acid, magnesium chloride, potassium chloride, purified water, sodium chloride, **sodium hydroxide, sodium lactate. **May contain these ingredients to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call (800) 616-2471

Major Lubricating Eye Drops 30ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major Lubricating Eye Drops 30ctMajor Lubricating Eye Drops 30ct

Major Lubricating Eye Drops 50ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Major Lubricating Eye Drops 50ctMajor Lubricating Eye Drops 50ct

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6848MAJOR LUBRICATING EYE DROPS (CARBOXYMETHYLCELLULOSE SODIUM) SOLUTION/ DROPS [HARVARD DRUG GROUP L L C]3Legacy NDC20231221_a8cbcbee-ecf6-d4b0-e053-2a95a90a56ed.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-68480904-6848-51, 0904-6848-46

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
MAGNESIUM CHLORIDE02F3473H9OIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311ACTIB
WATER059QF0KO0RIACT
SODIUM LACTATETU7HW0W0QTIACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
POTASSIUM CHLORIDE660YQ98I10IACT

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
3b56cead-448b-fbc1-e063-6394a90a1684a8cbcbee-ecf6-d4b0-e053-2a95a90a56ed2025-08-01WarningsExact identifier
spl set id: a8cbcbee-ecf6-d4b0-e053-2a95a90a56ed

Reported adverse events (FAERS/openFDA)#

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