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  5. Label Information: Sodium Chloride

FDA Label for Sodium Chloride

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS:
    2. INACTIVE INGREDIENTS:
    3. PRESERVATIVE:
    4. DIRECTIONS:
    5. DOSAGE & ADMINISTRATION:
    6. INDICATIONS:
    7. OTC - PURPOSE
    8. WARNINGS
    9. USER SAFETY WARNINGS
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. STORAGE AND HANDLING
    12. QUESTIONS?
    13. REPRESENTATIVE PACKAGING:

Sodium Chloride Product Label

The following document was submitted to the FDA by the labeler of this product Hub Pharmaceuticals. 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.

Drug Facts:



Active Ingredient

(each mL contains)

Purpose

Sodium Chloride USP

5% w/v (50mg)

Hypertonicity agent


Preservative:



Methylparaben

USP 0.023% w/v

PropylparabenUSP 0.01% w/v


Directions:



  • To open, twist cap clockwise to puncture sterile seal.
  • Remove cap.
  • Instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours as needed or directed by a doctor.

Dosage & Administration:



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


Indications:



For the temporaty relief of corneal edema.


Otc - Purpose



For the temporaty relief of corneal edema.


Warnings



External use only

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:

    • temporoary burning and iritation upon being instilled into eye may occur
    • To avoid contamination, do not touch top of container to any surface
    • Replace cap after using, keep tightly closed

      • In case of accidental ingestion, seek professional help or contact a Poision Control Center immediately.

      Stop use and ask a doctor if:

      • you experience eye pain, changes in vision, continued redness, or irritation of the eye.
      • if the condition worses or persists

User Safety Warnings



save box for complete warnings and instructions


Otc - Keep Out Of Reach Of Children



Keep out of reach of children

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


Storage And Handling



Store at room temperature 15°-30°C (59°-86°F).


Representative Packaging:



Sodium Chloride Solution Label

Sodium Chloride Solution Box


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