Sterile Dry Eye Relief

Sterile Dry Eye Relief
SPL v4
SPL
SPL Set ID f8da3af5-9172-4023-be82-0fd5bd891616
Route
OPHTHALMIC
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Polyethylene Glycol 400 (4 mg) Propylene Glycol (3 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Edetate Disodium Hypromellose, Unspecified Magnesium Chloride Potassium Chloride Water Sodium Borate Sodium Chloride Sodium Chlorite Zinc Chloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-03-09 Until 2026-11-30

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4%           Lubricant Propylene Glycol 0.3% Lubricant


Medication Information

Description

Active Ingredients Purpose Polyethylene Glycol 400 0.4%           Lubricant Propylene Glycol 0.3% Lubricant

.

TAMPER EVIDENT

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

*This product is not manufactured or distributed by Alcon, Inc., owner of the registered trademark Systane® Lubricant Gel Drops.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-9313

Made in India

100% Money back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698394

REV. 2/21

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye
Section 50565-1

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if you experience any of the following:

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1

Active Ingredients

Purpose

Polyethylene Glycol 400 0.4%          

Lubricant

Propylene Glycol 0.3%

Lubricant

Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information
  • store at room temperature
Inactive Ingredients

 boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

LEADER®

NDC 70000-0088-1

Sterile

Dry Eye Relief

Polyethylene Glycol 400, 0.4%

Propylene Glycol, 0.3%

Lubricant

0.33 FL OZ (10 mL)

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Structured Label Content

.

TAMPER EVIDENT

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

*This product is not manufactured or distributed by Alcon, Inc., owner of the registered trademark Systane® Lubricant Gel Drops.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-9313

Made in India

100% Money back Guarantee

Return to place of purchase if not satisfied.

Code: MH/DRUGS/28-KD/283

CIN 5698394

REV. 2/21

Uses
  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a protectant against further irritation or to relieve dryness of the eye
Section 50565-1 (50565-1)

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you experience any of the following:

  • you feel eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
Section 55105-1 (55105-1)

Active Ingredients

Purpose

Polyethylene Glycol 400 0.4%          

Lubricant

Propylene Glycol 0.3%

Lubricant

Warnings

For external use only

Directions
  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
Do Not Use (Do not use)
  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

 boric acid, edetate disodium , potassium chloride, mangnesium chloride , sodium chloride, sodium borate , purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

LEADER®

NDC 70000-0088-1

Sterile

Dry Eye Relief

Polyethylene Glycol 400, 0.4%

Propylene Glycol, 0.3%

Lubricant

0.33 FL OZ (10 mL)

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Advanced Ingredient Data


Raw Label Data

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