Artificial Tears
FDA Label NDC 13985-601

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mwi for the product Artificial Tears (NDC 13985-601). 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 other, active ingredient, purpose, uses, warnings, otc - stop use, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Polyvinyl Alcohol 1.4%

Purpose

Eye lubricant

Uses

For use as a lubricant to prevent further irritation or to relieve dryness of the eye(s).

Warnings

  • Do not use if imprinted seal on the bottle neck is broken or missing.
  • Do not use if solution changes color or becomes cloudy.
  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

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 - Keep Out Of Reach Of Children

Keep out of reach of children. If 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

  • Store at 20° to 25°C (68° to 77°F)
    [see USP Controlled Room Temperature].
  • Store away from heat.
  • Protect from freezing.
  • Keep tightly closed. RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive Ingredients

Benzalkonium Chloride 0.005% (preservative), Edetate Disodium, Sodium Chloride, Sodium Phosphate Dibasic, Sodium Phosphate Monobasic, Purified Water USP, Sodium Hydroxide and/or Hydrochloric Acid to adjust pH.

Questions?

call toll-free 1-800-932-5676.

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Apexa logo

AP 704002 15 mL

Principal Display Panel Text for Carton Label:

NDC 13985-601-15

Artificial Tears

Solution

Polyvinyl Alcohol 1.4%

STERILE

Lubricant Eye Drops

Prevents Irritation

and Relieves

Dryness of the eye

Apexa logo

AP 704002 15 mL

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