Systane Nighttime Ointment
FDA Label NDC 0065-0509

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alcon Laboratories, Inc. for the product Systane Nighttime (NDC 0065-0509). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient section, otc - purpose section, indications & usage section, warnings section, otc - do not use section, otc - when using section, otc - stop use section and ask a doctor if, otc - keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient Section

Mineral Oil 3%
White Petrolatum 94%

Otc - Purpose Section

Lubricant

Indications & Usage Section

  • For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

Warnings Section

For external use only

Otc - Do Not Use Section

  • if you are sensitive to any ingredient in this product

Otc - When Using Section

  • remove contact lenses before using
  • to avoid contamination, do not touch tip of container to any surface
  • replace cap after using

Otc - Stop Use Section And Ask A Doctor If

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Otc - Keep Out Of Reach Of Children Section

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration Section

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

  • Store at 8°-27°C (46°-80°F).

Inactive Ingredient Section

Anhydrous Liquid Lanolin 3%.

Otc - Questions Section

In the U.S., call 1-800-757-9195 or visit www.systane.com

Principal Display Panel

FOR NIGHTTIME PROTECTION OF DRY EYES

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

OVERNIGHT RELIEF

DRY EYE THERAPY

Systane®
NIGHTTIME
LUBRICANT EYE OINTMENT

Systane® Nighttime Lubricant Eye Ointment is a safe and effective formulation with no preservatives. This unpreserved ointment, when applied to the eyes, forms a smooth comfortable protective film, especially useful for nighttime protection and lubrication of dry eyes.

PRESERVATIVE-FREE

Alcon®
STERILE
3.5 g Tube (1/8 OZ NET WT)

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