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

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

Carton
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:0065-1431-051 in 1 CARTON
110 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34911/30/2009
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Laboratories, Inc.008018525MANUFACTURE(0065-1431)

Revised: 6/2011
Document Id: 04158e63-bdbc-071f-1300-302b3255e943
Set id: 91379a76-fb7f-8357-7d75-7da54fd6d08e
Version: 1
Effective Time: 20110621
 
Alcon Laboratories, Inc.