FDA.reportPublic FDA data

Leader Eye Drops Redness Relief (PLD)

Manufacturer
Cardinal Health | KC Pharmaceuticals, Inc.
Effective date
2026-09-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-11 03:02:23

Label at a glance#

ProductLeader Eye Drops Redness Relief
Active ingredientGLYCERIN, NAPHAZOLINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

for the relief of redness of the eye due to minor eye irritations for the temporary relief of burning and irritation due to dryness of the eye  for use as a protectant against further irritation or dryness of the eye

Dosage and administration

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years of age:ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purposes

OTC - PURPOSE SECTION

Glycerin...Lubricant

Naphazoline hydrochloride...Redness reliever

Uses

INDICATIONS & USAGE SECTION

  • for the relief of redness of the eye due to minor eye irritations
  • for the temporary relief of burning and irritation due to dryness of the eye 
  • for use as a protectant against further irritation or dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if solution changes color or becomes cloudy

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

narrow angle glaucoma

When using this product

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Instill 1 or 2 drops in the affected eye(s) up to 4 times daily

children under 6 years of age:ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call  1-888-527-4276

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

cartoncarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Twin sizeTwin size

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295137620GTIN-13: 0096295137620
EAN-13: 0096295137620
GTIN-12: 096295137620
UPC-A: 096295137620
GTIN storage (14 digits): 00096295137620		LeadEyeDRedRel.jpg
BarcodeEAN-130096295137637GTIN-13: 0096295137637
EAN-13: 0096295137637
GTIN-12: 096295137637
UPC-A: 096295137637
GTIN storage (14 digits): 00096295137637		LeaderRednessRelief-twin.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e18001c8-33ae-5f66-9cdc-a39724bd4573Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0010-1ML - Milliliter70000-0010a6ec9e55-719b-43a0-b8b9-249bd5df42f712020-01-03
70000-0010-2ML - Milliliter70000-0010eec7eb83-d715-447f-921f-10e435fc997112020-02-13

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
70000-001070000-0010-1, 70000-0010-2

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
GLYCERINPDC6A3C0OXACTIB
NAPHAZOLINE HYDROCHLORIDEMZ1131787DACTIB
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
BORIC ACIDR57ZHV85D4IACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM BORATE91MBZ8H3QOIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52026-03-09full-release2026-06-01 01:49:25

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
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
ndc (package): 70000-0010-1
ndc (package): 70000-0010-2
ndc (product): 70000-0010
ndc11 (package): 70000001001
ndc11 (package): 70000001002
spl id: 5b11dcac-4699-9567-e063-6294a90aadf3
spl set id: aee4bbe2-4f11-4c54-be8b-df48b3ba4f3a

Reported adverse events (FAERS/openFDA)#

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