Artificial Tears Lubricant Eye
FDA Label NDC 67091-284

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Artificial Tears Lubricant Eye (NDC 67091-284). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - stop use, otc - when using, otc - 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

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 product if 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 (Arttearscart)

Carton (Arttearscart)

* Please review the disclaimer below.