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

Systane by

Drug Labeling and Warnings

Systane by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Kaysersberg Pharmaceuticals, Laboratoire Unither. 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
• do not reuse
• once opened, discard

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s) gets worse, persists or lasts 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

Inactive Ingredients

Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. 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® ULTRA
LUBRICANT EYE DROPS    

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF
PRESERVATIVE-FREE VIALS  

STERILE
60 Vials 0.7 mL Each  

Alcon®
A Novartis company

INGREDIENTS AND APPEARANCE

SYSTANE  ULTRA
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1432
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
Aminomethylpropanol (UNII: LU49E6626Q)
BORIC ACID (UNII: R57ZHV85D4)
GUAR GUM (UNII: E89I1637KE)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SORBITOL (UNII: 506T60A25R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-1432-01	24 in 1 CARTON	07/27/2009	12/31/2017
1		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC: 0065-1432-02	4 in 1 CARTON	07/27/2009	12/31/2017
2		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
3	NDC: 0065-1432-03	72 in 1 CARTON	07/27/2009	12/31/2017
3		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
4	NDC: 0065-1432-04	5 in 1 CARTON	07/27/2009
4		.7 mL in 1 VIAL; Type 0: Not a Combination Product
5	NDC: 0065-1432-05	60 in 1 CARTON	07/27/2009
5		.7 mL in 1 VIAL; Type 0: Not a Combination Product
6	NDC: 0065-1432-06	25 in 1 CARTON	07/27/2009
6		.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	07/27/2009

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-1432)

Establishment
Name	Address	ID/FEI	Business Operations
Laboratoire Unither		574139809	manufacture(0065-1432)