Systane Ultra Preservative Free Solution/ Drops
FDA Label NDC 0065-1507

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 Ultra Preservative Free (NDC 0065-1507). 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 uses, warnings, do not use, when using the product, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Uses

  • for the temporary relief of burning and irritation due to 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

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 The Product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Keep Out Of Reach Of Children.

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

Directions

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
  • see side of carton for directions for use

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.

Directions For Use:

  • Hold the bottle just below the cap and twist the cap to open.
  • BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
  • Shake the bottle downward to remove residual product (see picture).
    • Use Diagram (Usediagam)

    Use Diagram (Usediagam)

    • Place 1 or 2 drops in the affected eye(s) as needed and blink.
    • After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
    • Replace cap after use.

Principal Display Panel

Systane®
LUBRICANT EYE DROPS
ULTRA PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration and lasting relief
Moisture rich formula for sensitive eyes
DOCTOR RECOMMENDED #1 Brand1

STERILE
10 mL (0.34 FL OZ)
Alcon

SIDE PANEL:
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.  

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


Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com
300049462-0721

Carton Label (Carton)

Carton Label (Carton)

* Please review the disclaimer below.