OTC Medication Information: Systane COMPLETE

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.

Systane COMPLETE Carton
Active Ingredients Purpose
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
alcon.medinfo@alcon.com
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
(click image for full-size original)
SYSTANE COMPLETE
propylene glycol solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0481
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Propylene Glycol (Propylene Glycol) Propylene Glycol .06 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Boric Acid
Dimyristoylphosphatidylglycerol, Dl-
Edetate Disodium
Guar Gum
Mineral Oil
Polyoxyl 40 Stearate
Sorbitan Tristearate
Sorbitol
Water
Hydrochloric Acid
Sodium Hydroxide
Polidronium Chloride
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0065-0481-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0481-10)
2 NDC:0065-0481-11 2 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0481-11)
3 NDC:0065-0481-01 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
3 1.5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0481-01)
4 NDC:0065-0481-55 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
4 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0481-55)
5 NDC:0065-0481-72 3 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
5 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0065-0481-72)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 01/18/2018
Labeler — Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research LLC 007672236 manufacture (0065-0481)

Revised: 02/2020 Alcon Laboratories, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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