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 Ingredients | Purpose |
| 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).
- 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
* Please review the disclaimer below.