Drugplain

Systane Lubricant 4 mg/mL

polyethylene glycol 400 and Propylene Glycol · SOLUTION/ DROPS · Alcon Laboratories, Inc.

3 Recalls on Record
Plain English

Systane Lubricant is a solution/ drops containing polyethylene glycol 400 and propylene glycol at 4 mg/mL, taken ophthalmic. Manufactured by Alcon Laboratories, Inc..

Key Facts

Brand Name
Systane Lubricant
Generic Name
polyethylene glycol 400 and Propylene Glycol
NDC Code (Product)
0065-0429
Manufacturer
Alcon Laboratories, Inc.
Strength
4 mg/mL
Dosage Form
SOLUTION/ DROPS
Route
OPHTHALMIC
Marketing Status
Application #
M018
Marketing Start
02/25/2003

Recall History

3 Recalls on Record
Class I12/18/2024

Alcon Research LLC

Non-Sterility

OngoingVoluntary: Firm initiated
Class II04/21/2026

Alcon Research LLC

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

OngoingVoluntary: Firm initiated
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

vision blurred227 reports
eye irritation183 reports
drug ineffective140 reports
product quality issue84 reports
eye pain72 reports
product odour abnormal67 reports
ocular hyperaemia53 reports
eye pruritus35 reports
dry eye23 reports
foreign body sensation in eyes23 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

Dosage & Administration

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

Warnings

Warnings For external use only

Frequently Asked Questions

What is Systane Lubricant used for?

Systane Lubricant contains polyethylene glycol 400 and Propylene Glycol. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is Systane Lubricant a controlled substance?

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

What is the generic name for Systane Lubricant?

The generic name for Systane Lubricant is polyethylene glycol 400 and Propylene Glycol. There are 8 other brand versions of polyethylene glycol 400 and Propylene Glycol.

What is the NDC code for Systane Lubricant 4 mg/mL?

The NDC (National Drug Code) for Systane Lubricant 4 mg/mL is 0065-0429, listed by Alcon Laboratories, Inc..

Product NDC

0065-0429

Package NDC

0065-0429-15

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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)