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 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

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
alcon.medinfo@alcon.com

www.systane.com

PRINCIPAL DISPLAY PANEL

Systane®
LUBRICANT EYE DROPS

ORIGINAL
LONG-LASTING
DRY EYE RELIEF

Refreshes & Lubricates
Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND1

Alcon
STERILE
15 mL (1/2 FL OZ)

SIDE PANEL

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.

Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

1Based on a survey of eye care professionals. Data on file.

www.alconpatents.com
Made in USA from domestic and imported materials

9016879-1118

LOT: EXP:

Systane®
LUBRICANT EYE DROPS
ORIGINAL LONG-LASTING
DRY EYE RELIEF

Refreshes & Lubricates
Soothing Comfort

#1 DOCTOR RECOMMENDED BRAND1

Alcon
STERILE
15 mL (1/2 FL OZ)

SIDE PANEL

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.

Enjoy lasting comfort with SYSTANE® Lubricant Eye Drops.

SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel refreshed.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

1Based on a survey of eye care professionals. Data on file.

www.alconpatents.com
Country of Origin: Singapore

SC00264-0219

LOT: EXP:

SYSTANE LUBRICANT
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-0429
Route of Administration	OPHTHALMIC

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

Ingredient Name	Strength
Inactive Ingredients
Boric Acid (UNII: R57ZHV85D4)
Calcium Chloride (UNII: M4I0D6VV5M)
Guar Gum (UNII: E89I1637KE)
Magnesium Chloride (UNII: 02F3473H9O)
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Zinc Chloride (UNII: 86Q357L16B)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0065-0429-15	1 in 1 CARTON	02/25/2003
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:0065-0429-21	2 in 1 CARTON	02/25/2003	05/31/2021
2		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:0065-0429-30	1 in 1 CARTON	02/25/2003
3		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC:0065-0429-36	2 in 1 CARTON	02/25/2003	08/31/2015
4		30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC:0065-0429-67	2 in 1 CARTON	07/01/2008	04/30/2018
5		20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	02/25/2003

Labeler - Alcon Laboratories, Inc. (008018525)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Research Ltd		007672236	manufacture(0065-0429)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Singapore Manufacturing Pte Ltd		595170137	manufacture(0065-0429)

Drug Facts