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  5. Label Information: Sodium Chloride

FDA Label for Sodium Chloride

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sodium Chloride Product Label

The following document was submitted to the FDA by the labeler of this product Akorn. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other



Drug Facts


Active Ingredient



Sodium Chloride 5%


Purpose



Hypertonicity Agent


Use



  • for temporary relief of corneal edema.

Otc - Do Not Use



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.

Otc - When Using



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

Otc - Stop 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.

Otc - Keep Out Of Reach Of Children



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) as needed.


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 Water for Injection.


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-623-12 Akorn Logo
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity
Eye Drops
15 mL (0.5 fl. oz.) Sterile

Principal Display Panel Text for Carton Label:

NDC 17478-623-12
5%
SODIUM
CHLORIDE
Ophthalmic
Solution, USP

Hypertonicity Eye Drops

Comparable to Muro-128®*
15 mL (0.5 fl. oz.) Sterile

Akorn Logo


* Please review the disclaimer below.