SPL v2
SPL
SPL Set ID dbf342d5-e794-fd42-e053-2a95a90a5a33
Route
OPHTHALMIC
Published
Effective Date 2016-06-15
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 Borate Sodium Chloride Sodium Chlorite

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-10-03

Description

Drug Facts

Purpose

Eye lubricant


Medication Information

Purpose

Eye lubricant

Description

Drug Facts

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.
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.

Section 51945-4

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 1%

Other Information
  • Use before expiration date marked on container.
  • Discard 30 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 contain hydrochloric acid and/or sodium hydroxide to adjust pH


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.
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.

Section 51945-4 (51945-4)

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 1%

Other Information (Other information)
  • Use before expiration date marked on container.
  • Discard 30 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 contain hydrochloric acid and/or sodium hydroxide to adjust pH


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)