SYSTANE ULTRA - polyethylene glycol 400 and propylene glycol solution/ drops
Alcon Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

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 irritation 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 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
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

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
10mL (1/3 FL OZ)

SIDE PANEL:

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.

www.alconpatents.com
Country of Origin Singapore

Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.

From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA.

ACTUAL SIZE

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

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

300051205-0122

Systane®
LUBRICANT EYE DROPS

ULTRA
HIGH PERFORMING
DRY EYE RELIEF

Fast-acting hydration
and lasting relief
Moisture rich formula

#1 Doctor Recommended Brand1Alcon STERILE
10mL (1/3 FL OZ)

SIDE PANEL:

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.

www.alconpatents.com
Made in USA from domestic and imported materials.

Open your eyes to a breakthrough in comfort with Systane® ULTRA Lubricant Eye Drops.

From first blink, eyes feel lubricated and refreshed.

Feel the difference in dry eye relief with SYSTANE® ULTRA.

ACTUAL SIZE

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

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

9016860-1118

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

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
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	10/01/2014

Labeler - Alcon Laboratories, Inc. (008018525)

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

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

Revised: 6/2022

Document Id: 34917dc0-4d32-48ed-96e0-49eaf6037e08

Set id: 0537c23a-15f7-be64-1231-a6c93468e9a8

Version: 16

Effective Time: 20220627

Alcon Laboratories, Inc.