Active Ingredients
Carboxymethylcellulose sodium 0.5%
Carboxymethylcellulose Sodium 0.5% Solution/ Drops
FDA Label NDC 51407-945
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Golden State Medical Supply, Inc. for the product Carboxymethylcellulose Sodium 0.5% (NDC 51407-945). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Eye lubricant
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 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.
Do Not Use
If solution changes color or becomes cloudy.
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.
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.
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.
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
Tamper Evident
DO NOT USE THIS PRODUCT IF THE INNER POUCH IS OPEN, TORN, OR MISSING.
Package Label.Principal Display Panel
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
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