FDA.reportPublic FDA data

Leader Lubricant Eye Drops 30ct

Manufacturer
KC Pharmaceuticals, Inc. | K.C. Pharmaceuticals, Inc. | Unimed
Effective date
2023-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:36:08

Label at a glance#

ProductLeader Lubricant Eye Drops 30ct
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

OTC - PURPOSE SECTION

Lubricant

Lubricant

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation of the eye due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if the solution changes color or becomes cloudy
  • if you are sensative 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
  • do not reuse
  • once opened, discard

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

Other information

OTHER SAFETY INFORMATION

  • store at 15°-25°C (59°-77°F)
  • 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

boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain sodium hydroxide and/or hydrochloric acid to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-527-4276

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

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
55651-01755651-017-01

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
SODIUM HYDROXIDE55X04QC32IIACT
HYDROCHLORIC ACIDQTT17582CBIACT
BORIC ACIDR57ZHV85D4IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
PROPYLENE GLYCOL6DC9Q167V3ACTIB
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
f5462642-b431-d2cc-e053-2995a90ae7f5f5462689-9722-5f00-e053-2a95a90a8ed82023-02-22WarningsExact identifier
spl id: f5462642-b431-d2cc-e053-2995a90ae7f5
spl set id: f5462689-9722-5f00-e053-2a95a90a8ed8

Reported adverse events (FAERS/openFDA)#

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