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  5. Label Information: Quality Choice Artificial Tears

FDA Label for Quality Choice Artificial Tears

View Indications, Usage & Precautions

Table of Contents

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

Quality Choice Artificial Tears Product Label

The following document was submitted to the FDA by the labeler of this product Chain Drug Marketing Association, 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.

Otc - Active Ingredient



​Active ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%


Otc - Purpose



​Purpose

Polyvinyl alcohol: Eye Lubricant

Povidone: Eye Lubricant


Indications & Usage



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



Warnings

For external use only


Otc - Do Not Use



  • Do not use this productif solution changes color or becomes cloudy

Otc - Stop Use



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

Otc - When Using



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

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately.


Dosage & Administration



Directions

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


Other Safety Information



Other information

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

Inactive Ingredient



Inactive ingredients

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


Package Label.Principal Display Panel



carton - QualChoiceArtTears

carton - QualChoiceArtTears


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