FDA.reportPublic FDA data

Eyes Irritation Relief

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Effective date
2025-09-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:14:29

Label at a glance#

ProductEyes Irritation Relief
Active ingredientPOLYVINYL ALCOHOL, UNSPECIFIED, POVIDONE, UNSPECIFIED, TETRAHYDROZOLINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyvinyl alcohol 0.5%

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Povidone 0.6%

Purpose

OTC - PURPOSE SECTION

Lubricant

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tetrahydrozoline hydrochloride 0.05%

Purpose

OTC - PURPOSE SECTION

Redness reliever

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use if

OTC - DO NOT USE SECTION

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 to any surface
  • replace cap after using
  • overuse may produce increased redness of the eye
  • pupils may become enlarged temporarily

Stop use & 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
  • symptoms last 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 to 2 drops in the affected eye(s) up to four times daily.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature
  • remove contact lenses before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride,  Disodium Hydrogen Phosphate Anhydrous, Disodium Edetate, Mannitol , Potassium Chloride, Purified Water, Sodium dihydrogen Phosphate Dihydrate, Sodium Chloride, Sodium Citrate , May Contain Hydrochloric Acid and/or Sodium Hydroxide to Adjust PH.

.

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT

Do not use if tape seals on carton top and bottom flaps are damaged or missing

To open cap, PUSH DOWN AND TURN.

*This product is not manufactured or distributed by Medtech Products, Inc., owner of the registered trademark Clear Eyes® Triple Action.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

Made in India

100% Money Back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698352

REV. 2/21

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0087-1

Sterile / Triple Action

Eye Irritation

Relief

Polyvinyl Alcohol / Povidone

Tetrahydrozoline Hydrochloride

Lubricant / Redness Reliever

  • Relieves Irritation and Redness
  • Moisturizes

0.5 FL OZ (15 mL)

0.5% / 0.6% / 0.05% bottle label
0.5% / 0.6% / 0.05% bottle label

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER™

NDC 70000-0087-1

Sterile / Triple Action

Eye

Irritation

Relief

Polyvinyl Alcohol / Povidone

Tetrahydrozoline Hydrochloride

Lubricant / Redness Reliever

  • Relieves Irritation and Redness
  • Moisturizes

Actual Bottle Size on Side Panel

COMPARE TO CLEAR EYES® TRIPLE ACTION active ingredients*

100% Money Back Guarantee

0.5 FL OZ (15 mL)

0.5% / 0.6% / 0.05% carton
0.5% / 0.6% / 0.05% carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1235569polyvinyl alcohol 0.5 % / povidone 0.6 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN3
1235569polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD3
1235569polyvinyl alcohol 0.5 % / povidone 0.6 % / tetrahydrozoline hydrochloride 0.05 % Ophthalmic SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
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7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
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8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0087-12025-09-22C16284748780-11030e365-0839-111a-e063-dadaa90a10e2Sterile Eyes Irritation Relief Triple Action
70000-0087-12024-01-30C16284748780-11030e365-0839-111a-e063-dadaa90a10e2Sterile Eyes Irritation Relief Triple Action

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0087-1Eyes Irritation Relief15 mL in 1 BOTTLE, DROPPERLIQUID153
70000-0087-1Eyes Irritation Relief1 in 1 BOXLIQUID13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0087-1ML - Milliliter70000-008788613991-c51f-4c55-b1c2-8a4577e5a90a12022-04-06

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-008770000-0087-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990ACTIB
POVIDONE, UNSPECIFIEDFZ989GH94EACTIB
TETRAHYDROZOLINE HYDROCHLORIDE0YZT43HS7DACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
EDETATE DISODIUM7FLD91C86KIACT
MANNITOL3OWL53L36AIACT
POTASSIUM CHLORIDE660YQ98I10IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
HYDROCHLORIC ACIDQTT17582CBCNTM
SODIUM CHLORIDE451W47IQ8XCNTM

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
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
ndc (package): 70000-0087-1
ndc (product): 70000-0087
ndc11 (package): 70000008701
spl id: aaaabf8c-8ca5-4fe3-8e21-ba270c7f3991
spl set id: bd2608c6-ffdf-352a-e053-2995a90a26a8

Reported adverse events (FAERS/openFDA)#

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