FDA.reportPublic FDA data

Ocusan Dry Eyes

Manufacturer
DLC Laboratories, Inc.
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:39:38

Label at a glance#

ProductOcusan Dry Eyes
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure10 sections

Dosage and administration

shake well before using instill 1 to 2 drops in the affected eye(s) as needed

Storage and handling

store at room temperature

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurposes
Polyethylene Glycol 400 1%Lubricant
proplyene GlycolLubricant

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation due to 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 ingredients 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or lasts 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
  • instill 1 to 2 drops in the affected eye(s) as needed

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, hydrochloric acid, hypromellose, potassium chloride, sodium chloride, sodium hydroxide, water for injection

Questions

OTC - QUESTIONS SECTION

1-800-858-3889

SPL UNCLASSIFIED SECTION

Distributed by:
DLC LABORATORIES, INC.
PARAMOUNT, CA 90723 USA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Advanced Formula!

Fase Acting


Ocusan ®

Dry Eyes

Moisturizes & Soothes Dry Eyes



Lubricant Eye Drops / Relieves Buring and Irritation

STERILE

1/2 FL OZ (15 mL)

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24286-1292OCUSAN DRY EYES (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) LIQUID [DLC LABORATORIES, INC.]4Legacy NDC20250419_a5b9209c-0187-9d5e-e053-2a95a90a20a6.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
24286-129224286-1292-5

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
BORIC ACIDR57ZHV85D4IACT
POTASSIUM CHLORIDE660YQ98I10IACT
HYDROCHLORIC ACIDQTT17582CBIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM CHLORIDE451W47IQ8XIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB

Source Document#

Source XML · Source PDF

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
33119fd5-f550-9f8f-e063-6294a90a5a04a5b9209c-0187-9d5e-e053-2a95a90a20a62025-04-18WarningsExact identifier
spl id: 33119fd5-f550-9f8f-e063-6294a90a5a04
spl set id: a5b9209c-0187-9d5e-e053-2a95a90a20a6

Reported adverse events (FAERS/openFDA)#

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