FDA Label for Systane Day And Night Value Pack
View Indications, Usage & Precautions
Systane Day And Night Value Pack 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 |
Active ingredients | Purpose |
Polyethylene Glycol 400 0.4% | Lubricant |
Propylene Glycol 0.3% | Lubricant |
Uses
- temporary relief of burning and irritation due to dryness of the eye
- temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
- temporary relief of burning and irritation due to dryness of the eye
- temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
Warnings
For external use only
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
- 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
- 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
- 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:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- shake well before using
- put 1 or 2 drops in the affected eye(s) as needed
- shake well before using
- put 1 or 2 drops in the affected eye(s) as needed
Other Information
- store at room temperature
- store at room temperature
Inactive Ingredients
aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Questions?
In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com [email protected]
In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com [email protected]
Package Label.Principal Display Panel
DAY & NIGHT VALUE PACK
Systane*
ULTRA
LUBRICANT EYE DROPS
DAYTIME
EXTENDED PROTECTION
FAST SYMPTOM RELIEF
GEL DROPS
LUBRICANT EYE GEL
NIIGHTTIIME
INTENSIVE GEL SHIELD
EASY APPLICATION
ENDURING RELIEF
Two 10 mL (1/3 FL OZ) Bottles
Alcon®
a Novartis company
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.
This Value Pack gives you long lasting protection and fast symptom relief during the day, as well as an intensive gel shield for enduring relief at night.
ACTUAL SIZE
U.S. Pat. www.alconpatents.com
© 2015, 2017 Novartis
*trademark of Novartis
Distributed by:
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 USA
Country of Origin: USA
AAA220038-1017
LOT:
EXP.:
Systane® ULTRA
LUBRICANT EYE DROPS
HIGH PERFORMANCE
STERILE
10 mL (1/3 FL OZ)
FOR EXTERNAL USE ONLY.
INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.
DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.
WARNINGS: See carton for WARNINGS.
INGREDIENTS:
Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.
Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Store at room temperature.
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Alcon®
LOT:
EXP.:
H14351-0516
Systane® GEL DROPS
LUBRICANT EYE DROPS
ANYTIME PROTECTION
STERILE
10 mL (1/3 FL OZ)
FOR EXTERNAL USE ONLY.
INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.
DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.
WARNINGS: See carton for WARNINGS.
INGREDIENTS:
Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%..
Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH..
Store at room temperature.
Alcon Laboratories, Inc.
6201 South Freeway,
Fort Worth, TX 76134 USA
©2010, 2013 Novartis
Alcon®
LOT:
EXP.:
H14343-0416
* Please review the disclaimer below.