SPL v2
SPL
SPL Set ID 3e4f7df5-6292-46ac-88cf-8d3f058168e8
Route
OPHTHALMIC
Published
Effective Date 2024-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Carboxymethylcellulose (5 mg)
Inactive Ingredients
Calcium Chloride Magnesium Chloride Potassium Chloride Water Sodium Chloride Sodium Lactate Hydrochloric Acid Sodium Hydroxide Gelatin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-24

Description

Carboxymethylcellulose sodium 0.5%

Purpose

Eye Lubricant


Medication Information

Purpose

Eye Lubricant

Description

Carboxymethylcellulose sodium 0.5%

Uses
  • For temporary relief of burning, irritation and discomfort due to dryness of the eye or exposure to wind or sun
  • protectant against further irritation
Warnings

For external use only.

Do not useif solution changes color or becomes cloudy

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse. Once opened, discard.

Stop use and ask a doctor if

  • you experience eye pain, changes in vision,continued redness or irritation of the eye
  • 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.

Directions
  • To open, TWIST AND PULL TAB TO REMOVE.
  • Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Product Label

Active Ingredient

Carboxymethylcellulose sodium 0.5%

Other Information
  • use before expiration date marked on container.
  • store at 59°-86°F (15°-30°C).
Inactive Ingredients

Calcium chloride, magnesium chloride, potassium chloride, purified water, gelatin, sodium chloride; and sodium lactate.May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Structured Label Content

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

Eye Lubricant

Warnings

For external use only.

Do not useif solution changes color or becomes cloudy

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse. Once opened, discard.

Stop use and ask a doctor if

  • you experience eye pain, changes in vision,continued redness or irritation of the eye
  • 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.

Directions
  • To open, TWIST AND PULL TAB TO REMOVE.
  • Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
Product Label (Product label)

Active Ingredient (Active ingredient)

Carboxymethylcellulose sodium 0.5%

Other Information (Other information)
  • use before expiration date marked on container.
  • store at 59°-86°F (15°-30°C).
Inactive Ingredients (Inactive ingredients)

Calcium chloride, magnesium chloride, potassium chloride, purified water, gelatin, sodium chloride; and sodium lactate.May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Advanced Ingredient Data


Raw Label Data

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