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

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Drug Facts

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

Warnings

For external use only                 

Do not use

When using this product

Stop use and ask a doctor if

you experience any of the following:

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

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

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.

300051246-1221

300051246-1221
SYSTANE ULTRA 
polyethylene glycol 400 and propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1431
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-1431-801 in 1 CARTON10/01/2014
13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0065-1431-011 in 1 CARTON10/01/2014
21.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:0065-1431-051 in 1 CARTON10/01/2014
310 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4NDC:0065-1431-183 in 1 CARTON10/01/2014
410 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5NDC:0065-1431-211 in 1 CARTON10/01/2014
53 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
6NDC:0065-1431-282 in 1 CARTON10/01/2014
64 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
7NDC:0065-1431-311 in 1 CARTON10/01/2014
74 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
8NDC:0065-1431-412 in 1 CARTON10/01/2014
810 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01810/01/2014
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-1431)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Singapore Manufacturing Pte Ltd595170137manufacture(0065-1431)

Revised: 11/2023
Document Id: e552d401-ec86-4cab-a8c7-1dc28068d26e
Set id: 0537c23a-15f7-be64-1231-a6c93468e9a8
Version: 18
Effective Time: 20231129
 
Alcon Laboratories, Inc.