Systane Hydration Pf Preservative Free Solution/ Drops
FDA Label NDC 0065-1437

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 0065-1437). 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
  • 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.: 

Carton (Carton)

Carton (Carton)

Drug Facts (Drugfacts)

Drug Facts (Drugfacts)

* Please review the disclaimer below.