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  5. Label Information: Artificial Tears

FDA Label for Artificial Tears

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. KEEP OUT OF REACH OF CHILDREN.
    4. USES
    5. WARNINGS
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. OTHER INFORMATION
    9. PRINCIPAL DISPLAY PANEL

Artificial Tears Product Label

The following document was submitted to the FDA by the labeler of this product Kc Pharmaceuticals, Inc.. 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



Polyvinyl alcohol 0.5%

Povidone 0.6%


Purpose



Polyvinyl alcohol - Eye lubricant

Povidone - Eye lubricant


Keep Out Of Reach Of Children.



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


Uses



  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for the temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun

Warnings



For external use only

  • Do not use this product if solution changes color or becomes cloudy

    • 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

      • When using this product

      • to avoid contamination, do not touch tip of container to any surface
      • replace cap after using.  Keep container tightly closed.
      • remove contact lens before using

Directions



Instill 1 or 2 drops in the affected eye(s) as needed.


Inactive Ingredients



benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate dibasic, and sodium phosphate monobasic


Other Information



  • Tamper Evident.  Do not use this product if imprinted neckband is missing or broken.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • Store at 15o - 30oC (59o - 86oF)

Principal Display Panel



ARTE


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