Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops

Carboxymethylcellulose Sodium 0.5% Lubricant Eye Drops
SPL v1
SPL
SPL Set ID 2e8a5fe2-144a-cdbb-e063-6394a90a2835
Route
OPHTHALMIC
Published
Effective Date 2025-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-20

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.
Section 51945-4

Carton

Preservative free

NDC 51407-945-30

Carboxymethylcellulose

Sodium

0.5%

Lubricant Eye Drops

Sterile

30 Single-Use Containers

0.02 FL OZ (0.5 mL) each

gsms

Manufactured by:

Huons Co,, Ltd.

Jecheon-si, Chungcheongbuk-do,

27159. South Korea

Marketed by:

GSMS Incorporated

Camarillo, CA 93012 USA

Rev. 01/25

Pouch

Preservative free

Carboxymethylcellulose

Sodium

Lubricant Eye Drops

0.5 mL

Single-Use

gsms

Open along the dotted line.

Label

Carboxymethylcellulose Sodium

Eye Drops Single-Use 0.5 mL

gsms

Rev. 01/25

EL9044-00

Warnings
  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.

Directions
  • To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
  • Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.
Do Not Use

If solution changes color or becomes cloudy.

Tamper Evident

DO NOT USE THIS PRODUCT IF THE INNER POUCH IS OPEN, TORN, OR MISSING.

Other Information
  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients

Carboxymethylcellulose sodium 0.5%

Inactive Ingredients

Calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; sodium chloride; and sodium lactate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments?

Call 1 (800) 284-8633, Monday to Friday 7 AM-4PM PST or visit www.gsms.us

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

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 51945-4 (51945-4)

Carton

Preservative free

NDC 51407-945-30

Carboxymethylcellulose

Sodium

0.5%

Lubricant Eye Drops

Sterile

30 Single-Use Containers

0.02 FL OZ (0.5 mL) each

gsms

Manufactured by:

Huons Co,, Ltd.

Jecheon-si, Chungcheongbuk-do,

27159. South Korea

Marketed by:

GSMS Incorporated

Camarillo, CA 93012 USA

Rev. 01/25

Pouch

Preservative free

Carboxymethylcellulose

Sodium

Lubricant Eye Drops

0.5 mL

Single-Use

gsms

Open along the dotted line.

Label

Carboxymethylcellulose Sodium

Eye Drops Single-Use 0.5 mL

gsms

Rev. 01/25

EL9044-00

Purpose

Eye lubricant

Warnings
  • For external use only.
  • To avoid contamination, do not touch tip of container to any surface.
  • Do not reuse. Once opened, discard.
  • Do not touch unit-dose tip to eye.

Directions
  • To open, TWIST AND PULL TAB TO REMOVE. Instill 1 or 2 drops in the affected eye(s) as needed and discard container.
  • Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.
Do Not Use (Do not use)

If solution changes color or becomes cloudy.

Tamper Evident (TAMPER EVIDENT)

DO NOT USE THIS PRODUCT IF THE INNER POUCH IS OPEN, TORN, OR MISSING.

Other Information (Other information)
  • Use only if single-use container is intact.
  • Use before expiration date marked on container.
  • Store at 59°-77°F (15°-25°C).
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.
Active Ingredients

Carboxymethylcellulose sodium 0.5%

Inactive Ingredients (Inactive ingredients)

Calcium chloride dihydrate; magnesium chloride hexahydrate; potassium chloride; purified water; sodium chloride; and sodium lactate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

Questions Or Comments? (Questions or comments?)

Call 1 (800) 284-8633, Monday to Friday 7 AM-4PM PST or visit www.gsms.us

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


Raw Label Data

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