Systane Solution/ Drops
FDA Label NDC 0065-0431

12 label sections · Submitted to the FDA by Alcon Research Ltd · 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.

Principal Display Panel

Systane®
LUBRICANT EYE DROPS    

ORIGINAL PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Convenient
Single Vials
On-the-Go

Great for Sensitive Eyes
Refreshes & Lubricates
Soothing Comfort

#1 Doctor Recommended Brand1

STERILE
30 Vials 0.7 mL Each

Alcon

Side Panel (s)

SOOTHING COMFORT
SYSTANE® Original PF
Lubricant Eye Drops is scientifically
formulated to shield eyes from
dry eye discomfort so that
eyes feel refreshed.  

LONG-LASTING RELIEF
SYSTANE® Original PF
Lubricant Eye Drops provides
long-lasting dry eye relief.  

PRESERVATIVE-FREE
SYSTANE® Original PF
Lubricant Eye Drops comes in
convenient preservative-free vials
so you can enjoy relief from dry
eye anytime, anywhere.  

TAMPER EVIDENT: Do not use if vial is
damaged or opened at time of purchase.

1 Based on a survey of eye care professionals.
Data on file.

www.alconpatents.com  

Made in France

435241-0819  

Systane®
LUBRICANT EYE DROPS  

ORIGINAL PF
PRESERVATIVE-FREE
DRY EYE RELIEF

DIRECTIONS:
Make sure container
is intact before use.
To open, COMPLETELY TWIST
OFF TAB.

Do not pull off.

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

Throw away container.
Do not reuse.

Manufactured for:
ALCON
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Front Label (Cartonfront)

Front Label (Cartonfront)

Back Label (Cartonback)

Back Label (Cartonback)

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