Carboxymethylcellulose Sodium
FDA Label NDC 49668-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promed Exports Private Limited for the product Carboxymethylcellulose Sodium (NDC 49668-001). 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 ingredient, uses, warnings, stop use and ask a doctor, keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Carboxymethylcellulose sodium (CMC) 0.5% ............... 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.

If used for post-operative (e.g. LASIK) dryness and discomfort, follow your eye doctor’s instructions.

Other Information

  • Use only if single-use container is intact.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

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

Package Label.Principal Display Panel- 30 Sterile Single Use Containers

CARBOXYMETHYLCELLULOSE SODIUM (CMC) 0.5%LUBRICANT EYE DROPS

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