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Systane by Alcon Laboratories, Inc.

Dosage form: gel
Ingredients: Polyethylene Glycol 400 4mg in 1mL, Propylene Glycol 3mg in 1mL
Labeler: Alcon Laboratories, Inc.
NDC Code: 0065-0454

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.

Systane® Gel Drops

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active IngredientsPurpose
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
  • instill 1 or 2 drops in the affected eye(s) as needed

Other information
  • store at room temperature

Inactive ingredients

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. 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

9013175-0416 

PRINCIPAL DISPLAY PANEL

Systane®
GEL DROPS
LUBRICANT EYE GEL

ANYTIME PROTECTION

INTENSIVE GEL SHIELD
EASY APPLICATION
ENDURING RELIEF

Alcon®
STERILE
10 mL (⅓ FL OZ)

SYSTANE  
polyethylene glycol 400 and propylene glycol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0454
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 4004 mg  in 1 mL
Propylene Glycol (Propylene Glycol) Propylene Glycol3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aminomethylpropanol 
Boric Acid 
Edetate Disodium 
Guar Gum 
Polidronium Chloride 
Potassium Chloride 
Sodium Chloride 
Sorbitol 
Water 
Hydrochloric Acid 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:0065-0454-0710 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/09/2011
Labeler - Alcon Laboratories, Inc. (008018525)
Registrant - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIOperations
Alcon Research, Ltd.007672236manufacture(0065-0454)

 
Alcon Laboratories, Inc.

Medically reviewed on Dec 11, 2017

See Also

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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