FDA.reportPublic FDA data

Sterile Lubricant drops

Manufacturer
CARDINAL HEALTH
Effective date
2022-12-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:45:09

Label at a glance#

ProductSterile Lubricant drops
Active ingredientPROPYLENE GLYCOL
Label structure8 sections

Indications and uses

for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun for use as a protectant against further irritation or to relieve dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye

Dosage and administration

shake well before using put 1 or 2 drops in the affected eye(s) as needed see side of carton for directions for use

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

OTC - PURPOSE SECTION

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation due to dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye

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

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

OTC - STOP USE SECTION

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
  • see side of carton for directions for use

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride solution, boric acid, calcium chloride, castor oil, disodium edetate, magnesium chloride, polyoxyl 40 hydrogenated castor oil, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, May contain sodium hydroxide, hydrochloric acid to adjust the pH

Questions?

OTC - QUESTIONS SECTION

1-855-314-1850

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0587-1ML - Milliliter70000-0587c032beaf-5b55-4050-9236-f45455d00ccb12022-09-12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-058770000-0587-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BORATE91MBZ8H3QOIACT
BORIC ACIDR57ZHV85D4IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CALCIUM CHLORIDEM4I0D6VV5MIACT
CASTOR OILD5340Y2I9GIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
POTASSIUM CHLORIDE660YQ98I10IACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONATE SODIUMYSE9PPT4THIACT

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
0fa82684-0905-5189-e063-6394a90aa7fcd08ba75b-da69-5f11-e053-2995a90ab7672024-01-23WarningsExact identifier
spl set id: d08ba75b-da69-5f11-e053-2995a90ab767

Reported adverse events (FAERS/openFDA)#

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