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  5. Label Information: Sodium Chlorode Hypertonicity Ophthalmic Solution

FDA Label for Sodium Chlorode Hypertonicity Ophthalmic Solution

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. QUESTIONS?
    10. PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – CARTON

Sodium Chlorode Hypertonicity Ophthalmic Solution Product Label

The following document was submitted to the FDA by the labeler of this product Rugby Laboratories. 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.

Active Ingredients



Sodium chloride 5%


Purpose



Hypertonicity agent


Uses



temporary relief of corneal edema


Warnings



Do not use

  • •except under the advice and supervision of a doctor
  • •if solution changes color or becomes cloudy

    • When using this product  

    • •it may cause temporary burning and irritation
    • •to avoid contamination do not touch tip of container to any surface
    • •replace cap after use

      • Stop use and ask a doctor if

      • •condition worsens or persists for more than 72 hours
      • •you experience eye pain, changes in vision, continued redness or irritation of the eye

Keep Out Of Reach Of Children.



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


Directions



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

Other Information



  • •store upright at 15° - 25°C (59° - 77°F)
  • •keep tightly closed
  • •serious side effects associated with use of the product may be reported to the phone number provided below

    •  


Inactive Ingredients



boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.


Questions?



[phone icon] Call 1-800-645-2158


Package/Label Principal Display Panel – Carton



carton - image 01

carton - image 01

NDC 0536-1254-94

Rugby®

Sodium Chloride
Hypertonicity
Ophthalmic
Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)


* Please review the disclaimer below.