Systane Lubricant (Polyethylene Glycol 400 And Propylene Glycol) Solution/ Drops [Alcon Laboratories, Inc.] -

SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]
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NDC	0065-0429-15, 0065-0429-21, 0065-0429-30, 0065-0429-36, 0065-0429-67
Set ID	15bc06ec-f3dc-3180-ca1a-106769a770ea
Category	HUMAN OTC DRUG LABEL
Packager	Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number	PART349

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ACTIVE INGREDIENT

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
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

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

alcon.medinfo@alcon.com
PRINCIPAL DISPLAY PANEL

#1 Doctor Recommended Brand1
Systane®
LUBRICANT EYE DROPS

LONG LASTING
SOOTHING COMFORT
DRY EYE THERAPY

Alcon®
STERILE
15 mL (1/2 FL OZ)

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.

#1 Doctor Recommended Brand1
Systane®
LUBRICANT EYE DROPS

LONG LASTING
SOOTHING COMFORT
DRY EYE THERAPY

Alcon
STERILE
15 mL (1/2 FL OZ)

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.

Country of Origin: Singapore

www.alconpatents.com

©2018 Novartis

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)

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)

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.

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

ACTUAL SIZE

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

www.alconpatents.com
Country of Origin: Singapore

SC00264-0219

LOT:    EXP:

INGREDIENTS AND APPEARANCE

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
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