sterile eyes irritation relief triple action

SPL v3

SPL

SPL Set ID bd2608c6-ffdf-352a-e053-2995a90a26a8

Route

ophthalmic

Published

Effective Date 2025-09-12

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

polyvinyl alcohol, unspecified (5 mg) povidone, unspecified (6 mg) tetrahydrozoline (0.5 mg)

Inactive Ingredients

benzalkonium chloride sodium phosphate, dibasic, anhydrous edetate disodium mannitol potassium chloride water sodium hydroxide sodium citrate, unspecified form sodium phosphate, monobasic, dihydrate

Identifiers & Packaging

Marketing Status

otc monograph drug completed Since 2021-03-09 Until 2026-11-30

Purpose

Lubricant

Description

Drug Facts

Medication Information

Warnings

For external use only

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

Purpose

Lubricant

Directions

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

Other Information

▪
store at room temperature
▪
remove contact lenses before using

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.

Description

Drug Facts

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)

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

Section 42229-5

Drug Facts

Do Not Use If

solution changes color or becomes cloudy.

Active Ingredient

Tetrahydrozoline hydrochloride 0.05%

Active Ingredients

Polyvinyl alcohol 0.5%

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.

Ask A Doctor Before Use If You Have

narrow angle glaucoma.

Structured Label Content

Warnings

For external use only

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

Purpose

Lubricant

Directions

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

Other Information (Other information)

▪
store at room temperature
▪
remove contact lenses before using

Inactive Ingredients (Inactive ingredients)

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)

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

Section 42229-5 (42229-5)

Drug Facts

Do Not Use If (Do not use if)

solution changes color or becomes cloudy.

Active Ingredient (Active ingredient)

Tetrahydrozoline hydrochloride 0.05%

Active Ingredients (Active ingredients)

Polyvinyl alcohol 0.5%

When Using This Product (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 (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. (Keep out of reach of children.)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

narrow angle glaucoma.

Advanced Ingredient Data

[{"name": "POLYVINYL ALCOHOL, UNSPECIFIED", "unii": "532B59J990", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "POVIDONE, UNSPECIFIED", "unii": "FZ989GH94E", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "TETRAHYDROZOLINE", "unii": "S9U025Y077", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BENZALKONIUM CHLORIDE", "unii": "F5UM2KM3W7", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, DIBASIC, ANHYDROUS", "unii": "22ADO53M6F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MANNITOL", "unii": "3OWL53L36A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM CHLORIDE", "unii": "660YQ98I10", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM HYDROXIDE", "unii": "55X04QC32I", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE", "unii": "5QWK665956", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "CNTM", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{".": "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", "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", "42229-5": "Drug Facts", "Purpose": "Lubricant", "Warnings": "For external use only", "Directions": "Instill 1 to 2 drops in the affected eye(s) up to four times daily.", "Do not use if": "solution changes color or becomes cloudy.", "Active ingredient": "Tetrahydrozoline hydrochloride 0.05%", "Other information": "▪ store at room temperature ▪ remove contact lenses before using", "Active ingredients": "Polyvinyl alcohol 0.5%", "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.", "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)", "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.", "Ask a doctor before use if you have": "narrow angle glaucoma."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:04.817212 · Updated: 2026-03-14T23:10:14.816739