FDA Label for Systane
View Indications, Usage & Precautions
Systane 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 ingredient | Purpose |
| Hypromellose (0.3%) | Lubricant |
Uses
- for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
- for use as a protectant against further irritation or to relieve dryness of the eye
- for the temporary relief of burning and irritation due to dryness of the eye
- for use as a protectant against further irritation or to relieve dryness of the eye
Warnings
For external use only
For external use only
Do Not Use
- if gel changes color or becomes cloudy
- if you are sensitive to any ingredient in this product
- 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
- replace cap after each use
- do not touch tip of container to any surface to avoid contamination
- replace cap after using
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
- eye pain
- changes in vision
- continued redness or irritation of the eye
- condition worsens or persists for more than 72 hours
Stop use and ask a doctor if you experience any of the following:
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
- put 1 or 2 drops in the affected eye(s) as needed
Other Information
store between 15o – 30oC (59o – 86oF)
- store at room temperature
Inactive Ingredients
carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.
carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.
Questions?
In the U.S. call toll-free
1-866-393-6336
[email protected]
TAMPER EVIDENT: For your protection, use only if pull tab is intact at time of purchase.
In the U.S. call 1-800-757-9195
[email protected]
www.systane.com
Other
| Active ingredient | Purpose |
| Hypromellose (0.3%) | Lubricant |
Principal Display Panel
NDC 0065047401
Systane* GEL
LUBRICANT EYE GEL
NIGHTTIME PROTECTION
Delivers long-lasting relief of dry eye symptoms
Alcon®
STERILE
10g (0.34 FL OZ)
Systane* Gel
LUBRICANT EYE GEL
Severe Dry Eye Relief
TAMPER EVIDENT:
For your protection, use only if pull tab is intact at time of purchase.
U.S. Patent Nos. 5,607,698; 5,683,993; 5,858,996
Processed in France with
US-origin active ingredient
Fort Worth, TX 76134 USA
© 2011, 2014 Novartis
* a trademark of Novartis
25368500
Systane®
LUBRICANT EYE GEL
NIGHT GEL
COMFORTING
DRY EYE RELIEF
Long lasting gel
for nighttime use
Soothing relief
#1 DOCTOR RECOMMENDED BRAND1
GEL
Alcon
STERILE 10g
(0.35 OZ)
TAMPER EVIDENT: For your
protection, use only if pull tab is
intact at time of purchase.
www.alconpatents.com
1 Based on a survey of eye care
professionals. Data on file.
Processed in France with
US-origin active ingredient for:
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
25368501-0519
25368501
LOT / EXP
* Please review the disclaimer below.