FDA Label for Systane Hydration Pf Preservative Free

View Indications, Usage & Precautions

Systane Hydration Pf Preservative Free Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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
  • 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



  • put 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 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 (Mon-Fri 9AM-5PM CST)

www.systane.com
[email protected]


Principal Display Panel



NEW
SYSTANE® Lubricant Eye Drops


HYDRATION PF
PRESERVATIVE-FREE
DRY EYE SYMPTOM RELIEF

Convenient
Single Vials
On-the-Go

Extra moisturizing for sensitive eyes
Longer lasting hydration*

#1 Doctor Recommended Brand1

Hydro Boost
Technology

STERILE
30
Vials 0.7 mL (0.02 FL OZ)

Alcon 

Experience preservative-free relief that’s extra moisturizing for sensitive eyes 

Common Dry Eye Symptoms
• Burning or stinging
• Fluctuating vision
• Irritation
• Watery eyes

TAMPER EVIDENT:
For your protection, 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.
* vs SYSTANE® ULTRA Lubricant Eye Drops

www.alconpatents.com
Made in France 

436270-0919 

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. 

ALCON
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

LOT:
EXP.: 


* Please review the disclaimer below.