Systane SportLubricant Eye Drops

Drug Labeling and Warnings

Drug Details [pdf]

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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Systane Sport
Lubricant Eye Drops

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

Uses

  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves 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 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 between 15°- 25°C (59°- 77°F)

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 toll free 1-800-757-9195
(Mon-Fri 9AM-5PM CST)
www.systane.com
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

NDC: 0065-1431-88

ON THE GO

Systane® Sport
LUBRICANT EYE DROPS

EXTENDED PROTECTION

FAST SYMPTOM RELIEF FROM EXPOSURE TO WIND OR SUN

#1 DOCTOR RECOMENDED BRAND

Alcon®

STERILE
Two 4 mL (0.14 FL OZ) Bottles Each

Often times you experience eye irritation from wind or sun. SYSTANE* SPORT Lubricant Eye Drops provide long lasting protection and fast symptom relief while enjoying your favorite outdoor activities.

ACTUAL SIZE

9012345-1015

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.

U.S. Pat. www.alconpatents.com

Alcon®

Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA
a Novartis company

Country of Origin: USA
© 2015 Novartis
*trademark of Novartis

LOT:

EXP.:

Carton

Systane* Sport
LUBRICANT EYE DROPS

EXTENDED PROTECTION

STERILE 4mL (0.14 FL OZ)

FOR TOPICAL USE ONLY

Uses: For the temporary relief of burning and irritation due to dryness of the eye. Temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.

Directions: Shake well before using and instill 1 or 2 drops in the affected eye(s) as needed.

Warnings: See carton for Warnings.

Ingredients:Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%. Inactives: 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.

Store between 15°- 25°C (59°- 77°F)

Distributed by: ALCON LABORATORIES, INC., Fort Worth, TX 76134 USA, a Novartis company © 2015 Novartis

*trademark of Novartis

Label
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, Unspecified - UNII:3WJQ0SDW1A) 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)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0065-1431-882 in 1 CARTON03/01/201609/11/2017
14 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 finalpart34903/01/201609/11/2017
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research Ltd007672236manufacture(0065-1431)

Revised: 7/2019