SYSTANE- polyethylene glycol and propylene glycol solution/ drops

Systane by

Drug Labeling and Warnings

Systane by is a Otc medication manufactured, distributed, or labeled by Alcon Research Ltd, Kaysersberg Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

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
• do not reuse
• once opened, discard

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

• instill 1 or 2 drops in the affected eye(s) as needed

Other Information

• store at room temperature
• protect from light

Inactive Ingredients

boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, 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

CONVENIENT PRESERVATIVE-FREE VIALS

#1 Doctor Recommended Brand1
Systane®
LUBRICANT EYE DROPS    

PRESERVATIVE-FREE VIALS

LONG LASTING RELIEF
SOOTHING COMFORT
DRY EYE THERAPY  

STERILE
30 Vials 0.7 mL Each  

Alcon®
a Novartis company

INGREDIENTS AND APPEARANCE

SYSTANE  
polyethylene glycol and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0431
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A)	Polyethylene Glycol 400	4 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GUAR GUM (UNII: E89I1637KE)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0431-04	4 in 1 CARTON	08/14/2009	12/31/2017
1		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 0065-0431-32	28 in 1 CARTON	10/30/2015	12/31/2017
2		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
3	NDC: 0065-0431-57	40 in 1 CARTON	08/14/2009	06/30/2011
3		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
4	NDC: 0065-0431-33	30 in 1 CARTON	10/30/2015
4		0.7 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	08/14/2009

Labeler - Alcon Research Ltd (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-0431)