MedPath

Eyes Irritation Relief

Sterile Eyes Irritation Relief Triple Action

Approved
Approval ID

bd2608c6-ffdf-352a-e053-2995a90a26a8

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 12, 2025

Manufacturers
FDA

CARDINAL HEALTH 110, LLC. DBA LEADER

DUNS: 063997360

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70000-0087
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Polyvinyl Alcohol and Povidone and Tetrahydrozoline Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateSeptember 12, 2025
FDA Product Classification

INGREDIENTS (14)

POLYVINYL ALCOHOL, UNSPECIFIEDActive
Quantity: 5 mg in 1 mL
Code: 532B59J990
Classification: ACTIB
POVIDONE, UNSPECIFIEDActive
Quantity: 6 mg in 1 mL
Code: FZ989GH94E
Classification: ACTIB
TETRAHYDROZOLINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: 0YZT43HS7D
Classification: ACTIB
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEInactive
Code: 5QWK665956
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: CNTM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: CNTM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2025

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

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2025

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

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/12/2025

.

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/12/2025

Active ingredient

Tetrahydrozoline hydrochloride 0.05%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/12/2025

Purpose

Redness reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2025

Warnings

For external use only

Do not use if

solution changes color or becomes cloudy.

Ask a doctor before use if you have

narrow angle glaucoma.

When using this product

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

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.

If swallowed, get medical help or contact a Poison Control Center(1-800-222-1222) right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2025

Directions

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/12/2025

Inactive ingredients

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.

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