Artificial Tears Solution/ Drops
FDA Label NDC 55651-008

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kc Pharmaceuticals, Inc. for the product Artificial Tears (NDC 55651-008). 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, keep out of reach of children., uses, warnings, directions, inactive ingredients, other information, 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

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)

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