Systane ULTRA

POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL OPHTHALMIC HUMAN OTC DRUG

Systane ULTRA is an FDA drug label for the active ingredient POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL manufactured by Alcon Laboratories, Inc. administered by OPHTHALMIC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231215.

Generic name
POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL
Manufacturer
Alcon Laboratories, Inc.
Product type
HUMAN OTC DRUG
Route
OPHTHALMIC
Dosage form
N/A
NDC
0065-1432
Application
M018
Label effective
20231215

Active ingredients

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

Indications & Usage

Uses For the temporary relief of burning and irritation due to dryness of the eye for temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun

Dosage & Administration

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

Contraindications

Not available.

Warnings

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 do not reuse once opened, discard 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.

Adverse Reactions

Not available.

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