FDA.reportPublic FDA data

Equaline Lubricant Eye Drops

Manufacturer
United Natural Foods, Inc. | KC Pharmaceuticals, Inc. | Unimed Pharmaceuticals, Inc.
Effective date
2024-02-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:11:42

Label at a glance#

ProductEqualine Lubricant Eye Drops
Active ingredientPROPYLENE GLYCOL, POLYETHYLENE GLYCOL 400
Label structure9 sections

Dosage and administration

put 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 0.4%

Propylene glycol 0.3%

Purposes

OTC - PURPOSE SECTION

Lubricant

Lubricant

Use

INDICATIONS & USAGE SECTION

  • for use as a protectant against 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

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

OTC - STOP USE SECTION

  • eye pain
  • changes in vision occur
  • continued redness or irritation of the eye
  • 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

put 1 or 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

boric acid, hypromellose, potassium chloride, purified water, sodium chloride, sodium hyaluronate, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-855-423-2630

Equaline Lubricant Eye Drops 10mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Equaline Lubricant Eye Drops 10mLEqualine Lubricant Eye Drops 10mL

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83455-20883455-208-01

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
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
POLYETHYLENE GLYCOL 400B697894SGQACTIB
BORIC ACIDR57ZHV85D4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
HYALURONATE SODIUMYSE9PPT4THIACT
SODIUM HYDROXIDE55X04QC32IIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT

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
2a9cbafc-346a-221d-e063-6394a90adb01fe4664e8-7591-b07a-e053-6394a90a1f982024-12-31WarningsExact identifier
spl set id: fe4664e8-7591-b07a-e053-6394a90a1f98

Reported adverse events (FAERS/openFDA)#

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