Sodium Chloride
FDA Label NDC 11822-5458

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Sodium Chloride (NDC 11822-5458). 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 other, active ingredient, purpose, use, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Sodium Chloride 5%

Purpose

Hypertonicity Agent

Use

  • for temporary relief of corneal edema.

Do Not Use

  • this product except under the advice and supervision of a doctor.
  • if imprinted seal is broken or missing.
  • if solution changes color or becomes cloudy.

When Using This Product

  • temporary burning and irritation upon being instilled into eye may occur.
  • to avoid contamination, do not touch tip of container to any surface.
  • replace cap after each use.

Stop Use And Ask A Doctor If

  • you experience eye pain.
  • you experience changes in vision.
  • redness or irritation of the eye continues
  • condition worsens or persists.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a doctor.

Other Information

  • Store at 20° to 25°C (68° to77°F) [see USP Controlled Room Temperature].
  • Keep tightly closed.

Inactive Ingredients

Boric Acid, Hypromellose 2906, Methylparaben 0.23 mg (0.023%), Propylparaben 0.1 mg (0.01%), Propylene Glycol, Sodium Borate, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH (6.0 to 8.0), and Purified Water USP.

Questions

call 1-800-579-8327

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

RITE
AID®
PHARMACY

eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
Sterile
0.5 FL OZ (15 mL)

Principal Display Panel Text for Carton Label:

RITE                      Compare to the active
AID®                     ingredient in Muro-128®*
PHARMACY         NDC 11822-5458-1
eye care
ophthalmic
solution
sodium chloride USP 5%
hypertonicity
eye drops
temporary relief
of corneal edema
doctor recommended
Sterile
0.5 FL OZ (15 mL)

* Please review the disclaimer below.