Quality Choice Artificial Tears Lubricant Eye Drops Solution/ Drops
FDA Label NDC 83324-189

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association, Inc. for the product Quality Choice Artificial Tears Lubricant Eye Drops (NDC 83324-189). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use this product if, when using this product, stop use and ask a doctor if you experience, keep out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Polyvinyl alcohol 0.5%

Povidone 0.6%

Purpose

Lubricant

Lubricant

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

When Using This Product

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

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 The Reach Of Children.

If accidentally swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Directions

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

Other Information

  • Store at 15°-30°C (59°-86°F)

Inactive Ingredients

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

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