SYSTANE LUBRICANT- polyethylene glycol 400 and propylene glycol solution/ drops

Systane Lubricant by

Drug Labeling and Warnings

Systane Lubricant by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research Ltd, Alcon Singapore Manufacturing Pte Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0429-15	1 in 1 CARTON	03/01/2003
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-0429-21	2 in 1 CARTON	02/10/2004
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/25/2003

Labeler - Alcon Laboratories, Inc. (008018525)

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

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