FDA.reportPublic FDA data

Leader Original Eye Drops

Manufacturer
Cardinal Health | KC Pharmaceuticals, Inc.
Effective date
2026-03-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:34:01

Label at a glance#

ProductLeader Original Eye Drops
Active ingredientTETRAHYDROZOLINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

relieves redness of the eye due to minor eye irritations

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to four times daily

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline HCL 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • relieves redness of the eye due to minor eye irritations

Warnings

WARNINGS SECTION

For external use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • pupils may become enlarged temporarily
  • to avoid contamination, do not touch tip of container to any surface. Replace cap after using
  • if solution changes color or becomes cloudy, do not use
  • overuse may produce increased redness of the eye
  • remove contact lens before using

Stop use and ask a doctor if

OTC - STOP USE SECTION

you experience

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye, or if the condition worsens or persists for 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 chlidren

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) up to four times daily

Other information

OTHER SAFETY INFORMATION

store at 15-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride

Questions or comments?

OTC - QUESTIONS SECTION

1-888-527-4276

Leader Original Eye Drops 15mL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader Original Eye Drops 15mLLeader Original Eye Drops 15mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0454-1ML - Milliliter70000-0454ba96d49d-b719-47c4-a239-087a65a280c212019-09-05

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-045470000-0454-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM BORATE91MBZ8H3QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB

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
4cb87ff7-fd7a-ce3c-e063-6294a90af306aec2ef95-0b9b-48dd-8809-73d19e309e4f2026-03-10WarningsExact identifier
spl set id: aec2ef95-0b9b-48dd-8809-73d19e309e4f

Reported adverse events (FAERS/openFDA)#

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