OTC Medication Information: Systane

SYSTANE — polyethylene glycol 400 and propylene glycol gel
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.

Carton
Active Ingredients Purpose
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
  • for use as a protectant against further irritation or to relieve 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:

  • you feel 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

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
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

Systane ®
LUBRICANT EYE GEL
GEL DROPS
SOOTHING DRY EYE RELIEF
Long-lasting formula
Day or night protection
#1 DOCTOR RECOMMENDED BRAND1
LIQUID GEL
STERILE
10mL (1/3 FL OZ)
Alcon

SIDE PANEL
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.
www.alconpatents.com
Made in USA from domestic and imported materials
Indulge your eyes in this easy-to-use droppable gel. Systane® GEL DROPS forms a protective shield over your eyes to provide enduring relief day or night.
1 Based on a survey of eye care professionals. Data on file.
300048642-0621
Alcon
Alcon Laboratories, Inc. Fort Worth, TX 76134 USA

Carton
(click image for full-size original)
SYSTANE polyethylene glycol 400 and propylene glycol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-0454
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Polyethylene Glycol 400 (Polyethylene Glycol 400) Polyethylene Glycol 400 4 mg in 1 mL
Propylene Glycol (Propylene Glycol) Propylene Glycol 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Aminomethylpropanol
Boric Acid
Edetate Disodium
Guaraprolose (3500 Mpa.S At 1%)
Polidronium Chloride
Potassium Chloride
Sodium Chloride
Sorbitol
Water
Hydrochloric Acid
Sodium Hydroxide
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0065-0454-07 10 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 02/09/2011
Labeler — Alcon Laboratories, Inc. (008018525)
Registrant — Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Operations
Alcon Research LLC 007672236 manufacture (0065-0454)

Revised: 06/2022 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.

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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