FDA Label for Systane Lubricant
View Indications, Usage & Precautions
Systane Lubricant 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 the temporary relief of burning and irritation due to 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
Stop Use And Ask A Doctor If
- you feel eye pain
- changes in vision occur
- redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Instill 1 or 2 drops in the affected eye(s) as needed.
Other Information
- Store at room temperature.
Inactive Ingredients:
Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions?
In the U.S. call 1-800-757-9195
www.systane.com
Principal Display Panel
#1 Doctor Recommended Brand1
SYSTANE®
LUBRICANT EYE DROPS
LONG LASTING
SOOTHING COMFORT
DRY EYE THERAPY
Alcon®
STERILE
15 mL (½ FL OZ)
Enjoy lasting, all-day comfort with SYTANE® Lubricant Eye Drops.
SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel moist and refreshed longer.
Feel its smooth soothing shield work immediately.
Finally, relief that lasts and lasts.
If you are not satisfied with SYSTANE® Lubricant Eye Drops, return the unused portion with proof of purchase to Alcon Laboratories for a full refund.
ACTUAL SIZE
Alcon®
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Printed in USA
TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal if damaged or missing at time of purchase.
U.S. Patent Nos 6,403,609, 6,583,124 and 6,838,449.
©2007-2009 Alcon, Inc.
9004494-0109
1 Survey of Ophthalmologists and Optometrists, Harris Interactive®, December 2008
SYSTANE®
LUBRICANT EYE DROPS
LONG LASTING
SOOTHING COMFORT
DRY EYE THERAPY
STERILE
15 mL (½ FL OZ)
STERILE – FOR TOPICAL EYE USE ONLY
INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.
DIRECTIONS: Instill 1 or 2 drops in the affected eye(s) as needed.
WARNINGS: If the solution changes color or becomes cloudy, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Keep this and all drugs out of the reach of children. See carton for complete WARNINGS.
INGREDIENTS:
Active: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.
Inactives: Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.
TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Store at room temperature.
U.S. Patent Nos. 6,403,609, 6,583,124 and 6,838,449.
Alcon Laboratories, Inc., Fort Worth, TX 76134 USA
©2007, 2014 Novartis
Alcon®
LOT/EXP.:
H12879-0414
* Please review the disclaimer below.