Sterile Lubricant Eye Drops

Sterile Lubricant Eye Drops
SPL v4
SPL
SPL Set ID 1ac2fe24-9ff6-48c1-b123-fbc0e48f5304
Route
OPHTHALMIC
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg)
Inactive Ingredients
Boric Acid Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Chloride Sodium Chlorite

Identifiers & Packaging

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

Description

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5%

.

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 Allergan, Inc., owner of the registered trademark

Refresh Tears® Lubricant Eye Drops.

DISTRIBUTED BY CARDINAL HEALT

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 5698378

REV. 2/21

CIN 5698386

REV. 2/21

Uses
  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • For use as a protectant against further irritation or to relieve dryness of the eye.
Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

  • If solution changes color or becomes cloudy, do not use.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Other Information
  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

  • Use before expiration date marked on container.

  • Discard 90 days after opening

  • Store at 59°-86°F (15°-30°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

LEADER®

NDC 70000-0090-1

Sterile

Lubricant

Eye Drops

Carboxymethylcellulose

Sodium, 0.5%

Eye Lubricant

Soothing

Relief for Dry Eyes

0.5 FL OZ (15 mL)

Stop Use and Ask A Doctor If

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


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 Allergan, Inc., owner of the registered trademark

Refresh Tears® Lubricant Eye Drops.

DISTRIBUTED BY CARDINAL HEALT

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 5698378

REV. 2/21

CIN 5698386

REV. 2/21

Uses
  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • For use as a protectant against further irritation or to relieve dryness of the eye.
Purpose

Eye lubricant

Warnings
  • For external use only.

  • To avoid contamination, do not touch tip of container to any surface. Replace cap after using.

  • If solution changes color or becomes cloudy, do not use.
Directions

Instill 1 or 2 drops in the affected eye(s) as needed.

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Other Information (Other information)
  • Use only if imprinted tape seals on top and bottom flaps are intact and clearly legible.

  • Use before expiration date marked on container.

  • Discard 90 days after opening

  • Store at 59°-86°F (15°-30°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Inactive Ingredients (Inactive ingredients)

Boric acid; calcium chloride; magnesium chloride; potassium chloride; purified water; stabilized oxychloro complex; and sodium chloride. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Principal Display Panel

LEADER®

NDC 70000-0090-1

Sterile

Lubricant

Eye Drops

Carboxymethylcellulose

Sodium, 0.5%

Eye Lubricant

Soothing

Relief for Dry Eyes

0.5 FL OZ (15 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists 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 right away.


Advanced Ingredient Data


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