sterile dry eye relief

sterile dry eye relief
SPL v3
SPL
SPL Set ID bd262028-32e9-052d-e053-2a95a90a5303
Route
ophthalmic
Published
Effective Date 2025-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
carboxymethylcellulose (10 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

Purpose

Eye lubricant

Description

Drug Facts


Medication Information

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

Eye lubricant

Directions

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

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; sodium borate; and sodium chloride, May Contain Hydrochloric Acid and /or Sodium hydroxide to adjust PH.

Description

Drug Facts

Principal Display Panel

LEADER®

NDC 70000-0089-1

Sterile

Dry Eye

Relief

Carboxymethylcellulose

Sodium, 1%

Eye Lubricant

Restores

Moisture in Eyes

0.5 FL OZ (15 mL)

.

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 Liquigel® Lubricant Eye Ge;.

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 5698360

REV. 2/21

Section 42229-5

Drug Facts

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

Active Ingredient

Carboxymethylcellulose sodium 1%


Structured Label Content

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

Eye lubricant

Directions

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

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; sodium borate; and sodium chloride, May Contain Hydrochloric Acid and /or Sodium hydroxide to adjust PH.

Principal Display Panel

LEADER®

NDC 70000-0089-1

Sterile

Dry Eye

Relief

Carboxymethylcellulose

Sodium, 1%

Eye Lubricant

Restores

Moisture in Eyes

0.5 FL OZ (15 mL)

.

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 Liquigel® Lubricant Eye Ge;.

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 5698360

REV. 2/21

Section 42229-5 (42229-5)

Drug Facts

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

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 1%


Advanced Ingredient Data


Raw Label Data

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