Drugplain

Systane Balance .06 mg/mL

propylene glycol · EMULSION · Alcon Laboratories, Inc.

1 Recall on Record
Plain English

Systane Balance is an over-the-counter eye drop used to relieve dry eye symptoms by lubricating and moisturizing the eye surface. It contains propylene glycol as its active ingredient and is designed to provide comfort for people experiencing dry, irritated eyes.

Key Facts

Brand Name
Systane Balance
Generic Name
propylene glycol
NDC Code (Product)
0065-1433
Manufacturer
Alcon Laboratories, Inc.
Strength
.06 mg/mL
Dosage Form
EMULSION
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
06/25/2010

Recall History

1 Recall on Record
Class II06/29/2022

Mckesson Medical-Surgical Inc. Corporate Office

CGMP Deviations: products were stored outside the drug label specifications.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

eye irritation428 reports
vision blurred228 reports
drug ineffective216 reports
eye pain213 reports
ocular hyperaemia195 reports
dry eye173 reports
nausea169 reports
eye pruritus144 reports
vomiting133 reports
foreign body sensation in eyes132 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of burning and irritation due to dryness of the eye for use as a lubricant to prevent further irritation or to relive dryness of the eye

Dosage & Administration

Directions shake well before using put 1 or 2 drops in the affected eye(s) as needed

Warnings

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.

Frequently Asked Questions

What is Systane Balance used for?

Systane Balance is an over-the-counter eye drop used to relieve dry eye symptoms by lubricating and moisturizing the eye surface. It contains propylene glycol as its active ingredient and is designed to provide comfort for people experiencing dry, irritated eyes.

Is Systane Balance a controlled substance?

Systane Balance is not classified as a controlled substance by the DEA.

What is the generic name for Systane Balance?

The generic name for Systane Balance is propylene glycol. There are 12 other brand versions of propylene glycol.

What is the NDC code for Systane Balance .06 mg/mL?

The NDC (National Drug Code) for Systane Balance .06 mg/mL is 0065-1433, listed by Alcon Laboratories, Inc..

Product NDC

0065-1433

Package NDC

0065-1433-02

Other Propylene Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)