Systane 4 mg/mL
polyethylene glycol and propylene glycol · SOLUTION/ DROPS · Alcon Research Ltd
Systane is a solution/ drops containing polyethylene glycol and propylene glycol at 4 mg/mL, taken ophthalmic. Manufactured by Alcon Research Ltd.
Key Facts
- Brand Name
- Systane
- Generic Name
- polyethylene glycol and propylene glycol
- NDC Code (Product)
0065-0431- Manufacturer
- Alcon Research Ltd
- Strength
- 4 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- M018
- Marketing Start
- 10/30/2015
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Alcon Research LLC
Non-Sterility
Family Dollar Stores, Llc.
CGMP Deviations: product held outside appropriate storage temperature conditions.
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Mckesson Medical-Surgical Inc. Corporate Office
CGMP Deviations: products were stored outside the drug label specifications.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Uses for the temporary relief of burning and irritation due to dryness of the eye for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
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
Frequently Asked Questions
What is Systane used for?
Systane contains polyethylene glycol and propylene glycol. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Systane a controlled substance?
Systane is not classified as a controlled substance by the DEA.
What is the generic name for Systane?
The generic name for Systane is polyethylene glycol and propylene glycol. There are 1 other brand versions of polyethylene glycol and propylene glycol.
What is the NDC code for Systane 4 mg/mL?
The NDC (National Drug Code) for Systane 4 mg/mL is 0065-0431, listed by Alcon Research Ltd.