Systane Solution/ Drops
FDA Label NDC 0065-0431

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Research Ltd for the product Systane (NDC 0065-0431). 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 - purpose, uses, warnings, do not use, when using this product, otc - stop use, 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

Otc - Purpose

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do Not Use

  • if this product changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

When Using This Product

  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard

Otc - Stop Use

Stop use and ask a doctor if you experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists 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 or 2 drops in the affected eye(s) as needed

Other Information

  • store at room temperature
  • protect from light

Inactive Ingredients

boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195
www.systane.com

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CONVENIENT PRESERVATIVE-FREE VIALS

#1 Doctor Recommended Brand1
Systane®
LUBRICANT EYE DROPS    

PRESERVATIVE-FREE VIALS

LONG LASTING RELIEF
SOOTHING COMFORT
DRY EYE THERAPY  

STERILE
30 Vials 0.7 mL Each  

Alcon®
a Novartis company

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