Gentle Eyes Lubricant Eye Drops™

Gentle Eyes Lubricant Eye Drops™
SPL v2
SPL
SPL Set ID 13f99af6-b7d8-a092-e063-6394a90a5daa
Route
OPHTHALMIC
Published
Effective Date 2024-03-18
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 Chlorite Sodium Borate Sodium Chloride Hydrochloric Acid Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-18

Description

Carboxymethylcellulose sodium 0.5%

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Carboxymethylcellulose sodium 0.5%

Uses
  • For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun.
  • May be used as a protectant against further irritation.
Warnings
  • For use in eyes only.
  • Retain outer carton for full product drug facts.
Directions

  • Wash your hands.
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use

• If solution changes color or becomes cloudy.

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Other Information
  • Store at room temperature 15°-30°C (59°-86°F).
  • Keep tightly closed.
  • EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.
  • The use of this container by more than one person may spread infection.
Inactive Ingredients

Boric acid, Calcium| chloride, Hydrochloric acid*, Magnesium chloride, Potassium chloride, Purified water, Sodium borate, Sodium chloride, Sodium hydroxide*. Stabilized axychloro complex 2.5%.

*May contain one or more of these ingredients to adjust pH.

Questions Or Comments?

1-888-969-6855

8 am to 4 pm EST;

Monday - Friday.

Principal Display Panel

When Using This Product:
  • Avoid contamination, do not touch tip of container to any surface.
  • Replace cap after use.
If Pregnant Or Breast Feeding
  • If pregnant or breast feeding, ask a health professional before use.
Stop Use and Ask A Doctor If:
  • You experience eye pain, changes in vision, continued redness or irritation of the eye.
  • 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 awav.


Structured Label Content

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

Eye lubricant

Warnings
  • For use in eyes only.
  • Retain outer carton for full product drug facts.
Directions

  • Wash your hands.
  • Instill 1 or 2 drops in the affected eye(s) as needed.
Do Not Use (Do not use)

• If solution changes color or becomes cloudy.

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Other Information (Other information)
  • Store at room temperature 15°-30°C (59°-86°F).
  • Keep tightly closed.
  • EXPIRATION DATE ONLY REFERS TO THE UNOPENED BOTTLE.
  • The use of this container by more than one person may spread infection.
Inactive Ingredients (Inactive ingredients)

Boric acid, Calcium| chloride, Hydrochloric acid*, Magnesium chloride, Potassium chloride, Purified water, Sodium borate, Sodium chloride, Sodium hydroxide*. Stabilized axychloro complex 2.5%.

*May contain one or more of these ingredients to adjust pH.

Questions Or Comments? (Questions or comments?)

1-888-969-6855

8 am to 4 pm EST;

Monday - Friday.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

When Using This Product: (When using this product:)
  • Avoid contamination, do not touch tip of container to any surface.
  • Replace cap after use.
If Pregnant Or Breast Feeding (If pregnant or breast feeding)
  • If pregnant or breast feeding, ask a health professional before use.
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.
  • The condition worsens or persists for more than 72 hours.
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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