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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. WARNINGS
    6. STOP USE AND ASK A DOCTOR IF
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. 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.


Warnings



  • Do not use this product except under the advice and supervision of a doctor.
  • Do not use if bottom ridge of tube cap is exposed
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.
  • May cause temporary burning and irritation upon application into the eye.

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



Apply small amount (one-fourth inch) to the inside of affected eye(s) every 3 to 4 hours, or as directed by a doctor.


Other Information



  • Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed.
  • See crimp for Control Number and Expiration Date.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients



Mineral Oil, Modified Lanolin, Water for Injection and White Petrolatum.


Package Label.Principal Display Panel



Principal Display Panel Text for Container Label:

NDC 17478-622-35

Sodium Chloride Ophthalmic

Ointment USP, 5%

Hypertonicity Eye Ointment Sterile

FOR OPHTHALMIC USE ONLY. Net Wt. 3.5 g (1/8 oz.)

Principal Display Panel Text for Carton Label:

NDC 17478-622-35

3.5 g

Sodium

Chloride

Ophthalmic

Ointment

USP, 5%

Hypertonicity

Eye Ointment

Comparable to MURO 128®

Sterile

Net Wt. 3.5 g (1/8 oz.)


* Please review the disclaimer below.