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., Alcon Research LLC, 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 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

• shake well before using 
• put 1 or 2 drops in the affected eye(s) as needed

Other information

• store at room temperature

Inactive ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquarternium-1) 0.001% preservative, 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
MedInfo@AlconLabs.com

Drug Facts

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 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

• Shake well before using.

Other Information

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Store at room temperature.

Inactive Ingredients

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.

Questions?

In the U.S. call 1-800-757-9195
www.systane.com
alcon.medinfo@alcon.com

Drug Facts

ACTIVE INGREDIENT

PURPOSE

• 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
• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun

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

• shake well before using
• put 1 or 2 drops in the affected eye(s) as needed

Other information

• store at room temperature

Inactive ingredients

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.

Questions?

In the U.S.
call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

Systane*
ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor
Recommended
Dry Eye Brand†

Alcon®
STERILE
3 mL (0.1 FL OZ)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE
3mL (0.1 FL OZ)

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE
EXTENDED PROTECTION
FAST SYMPTOM RELIEF

#1 Doctor Recommended Brand1

Alcon
STERILE 
10  mL (⅓ FL OZ)

Systane® 
LUBRICANT EYE DROPS

ULTRA
HIGH PERFORMING DRY EYE RELIEF

Fast-acting hydration and lasting relief

Moisture rich formula

#1 Doctor Recommended Brand1

Alcon

STERILE 

10  mL (1/3 FL OZ)

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: 0065-1431-80	1 in 1 CARTON	10/01/2014
1		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-1431-01	1 in 1 CARTON	10/01/2014
2		1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0065-1431-05	1 in 1 CARTON	10/01/2014
3		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 0065-1431-18	3 in 1 CARTON	10/01/2014
4		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC: 0065-1431-21	1 in 1 CARTON	10/01/2014
5		3 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
6	NDC: 0065-1431-28	2 in 1 CARTON	10/01/2014
6		4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
7	NDC: 0065-1431-31	1 in 1 CARTON	10/01/2014
7		4 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
8	NDC: 0065-1431-41	2 in 1 CARTON	10/01/2014
8		10 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	10/01/2014

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-1431)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Singapore Manufacturing Pte Ltd		595170137	manufacture(0065-1431)