Artificial Tears
FDA Label NDC 41520-865

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by American Sales Company for the product Artificial Tears (NDC 41520-865). 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 ingredient, purpose, uses, warnings, do not use this product if, stop use and ask a doctor if you experience, when using this product, 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 Ingredient

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene Glycol 400 1%

Purpose

Lubricant

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


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

Keep Out Of Reach Of Children.

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

Directions

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

Other Information

  • Do not use if the tamper-resistant bottle cap is broken or opened.
  • RETAIN THIS CARTON FOR FUTURE REFERENCE
  • store between 15° to 30°C (59°F to 86°F)

Inactive Ingredients

aminoacetic acid, ascorbic acid, benzalkonium chloride, boric acid, dextrose, disodium phosphate, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, sodium citrate, sodium lactate

Package Principal Display Panel

Care One Tears

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