Systane Lubricant

polyethylene glycol 400 and Propylene Glycol · Solution/ Drops · Ophthalmic

Over the counter 1 recall

Active ingredient

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Purpose

Active Ingredients Purpose Polyethylene Glycol 400 0.4% Lubricant Propylene Glycol 0.3% Lubricant

Uses

Uses For the temporary relief of burning and irritation due to dryness of the eye

Warnings

Warnings For external use only

Do not use

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

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

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions put 1 or 2 drops in the affected eye(s) as needed

Inactive ingredients

Inactive Ingredients: Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com

Label text from the FDA structured product label by Alcon Laboratories, Inc. (revised Dec 15, 2023). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Systane Lubricant NDC products (1)

NDCStrength & formLabelerType
0065-0429Polyethylene Glycol 400 4 mg/mL; Propylene Glycol 3 mg/mL
Solution/ Drops
Alcon Laboratories, Inc.OTC MONOGRAPH DRUG

Systane Lubricant recalls

Frequently asked questions

What is Systane Lubricant used for?

Uses For the temporary relief of burning and irritation due to dryness of the eye

Who makes Systane Lubricant?

Systane Lubricant is listed by 1 labeler in the FDA NDC directory, including Alcon Laboratories, Inc..

Has Systane Lubricant been recalled?

The FDA enforcement database lists 1 recall for Systane Lubricant, most recently D-1314-2022 (class ii): CGMP Deviations: products were stored outside the drug label specifications.