Systane Hydration Pf Preservative Free Solution/ Drops
FDA Label NDC 0065-1510

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 Hydration Pf Preservative Free (NDC 0065-1510). 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 use as a protectant against 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

Keep Out Of Reach Of Children.

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

Directions

  • 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 borate, sodium chloride, sodium hyaluronate, 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
[email protected]

Directions for Use:

  • Hold the bottle just below the cap and twist the cap 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 (Usediagram)

    Use Diagram (Usediagram)

    • 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.

      • 300039850-0920

      Top of Carton:
      SYSTANE® Lubricant Eye Drops


      HYDRATION PF
      PRESERVATIVE-FREE
      DRY EYE SYMPTOM RELIEF

Principal Display Panel

New! Preservative-Free Bottle


SYSTANE® Lubricant Eye Drops 

HYDRATION PF  
PRESERVATIVE-FREE
DRY EYE SYMPTOM RELIEF     

Extra moisturizing for sensitive eyes   
Longer lasting hydration*

#1 Doctor Recommended Brand1
Hydro Boost Technology

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.   
*vs SYSTANE® ULTRA Lubricant Eye Drops     

Alcon Laboratories, Inc.   
Fort Worth, TX 76134 USA   
Country of Origin Belgium   
www.alconpatents.com

Carton Image (Carton)

Carton Image (Carton)

* Please review the disclaimer below.