Systane Solution/ Drops
FDA Label NDC 0065-1432

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 Laboratories, Inc. for the product Systane (NDC 0065-1432). 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, uses, for external use only.  do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

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

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

Stop Use And Ask A Doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts 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 room temperature

Inactive Ingredients

Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. 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® ULTRA
LUBRICANT EYE DROPS    

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF
PRESERVATIVE-FREE VIALS  

STERILE
60 Vials 0.7 mL Each  

Alcon®
A Novartis company

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