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

Systane Ultra by

Drug Labeling and Warnings

Systane Ultra by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OTC - ACTIVE INGREDIENT SECTION

Polyethylene Glycol 400 0.4%
Propylene Glycol 0.3%

OTC - PURPOSE SECTION

Lubricant

INDICATIONS & USAGE SECTION

• For the temporary relief of burning and irritation due to dryness of the eye

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

OTC - WHEN USING SECTION

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

• Shake well before using.
• Instill 1 or 2 drops in the affected eye(s) as needed.

OTHER SAFETY INFORMATION

• Store at room temperature.

INACTIVE INGREDIENT SECTION

Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

OTC - QUESTIONS SECTION

In the U.S. call 1-800-757-9195
www.systane.com
MedInfo@AlconLabs.com

PRINCIPAL DISPLAY PANEL

Systane®
ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Brand1

Alcon®

STERILE
10 mL (⅓ FL OZ)

9006416-0111

INGREDIENTS AND APPEARANCE

SYSTANE ULTRA  
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1431
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
Aminomethylpropanol (UNII: LU49E6626Q)
Boric Acid (UNII: R57ZHV85D4)
Guar Gum (UNII: E89I1637KE)
Polidronium Chloride (UNII: 6716Z5YR3G)
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: 0065-1431-05	1 in 1 CARTON
1		10 mL in 1 BOTTLE, DROPPER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	11/30/2009

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Laboratories, Inc.		008018525	MANUFACTURE(0065-1431)