Systane Complete Pf Emulsion
FDA Label NDC 0065-1509

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 Complete Pf (NDC 0065-1509). 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, warnings, do not use, when using this product, 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

Otc - Active Ingredient

Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

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
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve 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
  • replace cap after each use

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

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

  • 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

boric acid, dimyristoyl phosphatidylglycerol, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195
www.systane.com
[email protected]

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).
    • Before First Use (Beforefirstuse)

    Before First Use (Beforefirstuse)

    • 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 on side panel).
    • Replace cap after use.

      • 1Based on a survey of eye care professionals. Data on file.   
       *vs SYSTANE® BALANCE Lubricant Eye Drops

Principal Display Panel

Preservative-Free

Systane® LUBRICANT EYE DROPS

COMPLETE PF
PRESERVATIVE-FREE
DRY EYE RELIEF

Fast-acting hydration for sensitive eyes

Tear evaporation protection

Nano-droplets for better coverage*

#1 DOCTOR RECOMMENDED BRAND1

Alcon

Sterile
10mL (0.34 FL OZ)

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.

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

300048582-0521

Systane Complete Pf (Carton)

Systane Complete Pf (Carton)

* Please review the disclaimer below.