Artificial Tears Lubricant Eye Liquid
FDA Label NDC 67172-181

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prestige Brands Holdings, Inc. for the product Artificial Tears Lubricant Eye (NDC 67172-181). 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 if, when using this product:, stop use and ask a doctor if:, keep out of 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

Uses

  • For the temporary relief of burning & irritations due to dryness of the eye.
  • For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

For external use only

Do Not Use If

solution changes color or becomes cloudy.

When Using This Product:

  • to avoid contamination, do not touch tip to any surface.
  • replace cap after using.

Stop Use And Ask A Doctor If:

  • you experience eye pain
  • you experience changes in vision
  • you experience continued redness or irritation of the eye
  • the condition worsens
  • symptoms last for more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other Information

  • Store at room temperature
  • Remove contact lenses before using
  • Tamper Evident: do not use if neckband on bottle is broken or missing.

Inactive Ingredients

benzalkonium chloride, dextrose, edetate disodium, potassium chloride, purified water, sodium bicarbonate, sodium chloride, sodium citrate, sodium phosphate (mono- and dibasic)

Questions?

1-877-274-1787

Principal Display Panel

Sterile
Artificial Tears Lubricant Eye Drops
0.5 FL OZ (15 mL)

Principal Display Panelsterileartificial Tears Lubricant Eye Drops0.5 Fl Oz (15 mL) (Artificial Tears Lubricant Eye Drops 01)

Principal Display Panelsterileartificial Tears Lubricant Eye Drops0.5 Fl Oz (15 mL) (Artificial Tears Lubricant Eye Drops 01)

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