Systane COMPLETE Drug Facts

Systane COMPLETE Drug Facts

Drug Labeling and Warnings

Drug Details

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SYSTANE COMPLETE - 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 COMPLETE

Drug Facts

Active IngredientsPurpose
Propylene Glycol 0.6%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 irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

  • if this product changes color
  • 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

boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative,  sorbitan tristearate, 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
[email protected]
www.systane.com

PRINCIPAL DISPLAY PANEL

Systane®LUBRICANT EYE DROPS

COMPLETE
OPTIMAL DRY EYE RELIEF

Fast-acting hydration
Tear evaporation protection
Nano-droplets for better coverage*  

#1 DOCTOR RECOMMENDED BRAND1

nano droplet  

Alcon

STERILE

10mL (1/3 FL OZ)

Systane COMPLETE Carton
SYSTANE COMPLETE 
propylene glycol solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0065-0481
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol.06 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Boric Acid (UNII: R57ZHV85D4)  
Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R)  
Edetate Disodium (UNII: 7FLD91C86K)  
Guar Gum (UNII: E89I1637KE)  
Mineral Oil (UNII: T5L8T28FGP)  
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)  
Sorbitan Tristearate (UNII: 6LUM696811)  
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Polidronium Chloride (UNII: 6716Z5YR3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0065-0481-101 in 1 CARTON01/18/2018
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC: 0065-0481-112 in 1 CARTON01/18/2018
210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC: 0065-0481-011 in 1 CARTON04/23/2018
31.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4NDC: 0065-0481-551 in 1 CARTON12/10/2018
45 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 finalpart34901/18/2018
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-0481)

Revised: 12/2019
 
Alcon Laboratories, Inc.


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