Systane Lubricant Solution/ Drops
FDA Label NDC 0065-0429

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 Lubricant (NDC 0065-0429). 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 - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Active IngredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

  • For the temporary relief of burning and irritation due to dryness of the eye.

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
  • replace cap after each use

Stop Use 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

Keep Out Of Reach Of Children.

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

Directions

  • Instill 1 or 2 drops in the affected eye(s) as needed.

Other Information

  • Store at room temperature.

Inactive Ingredients:

Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

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

Principal Display Panel

#1 Doctor Recommended Brand1

SYSTANE®
LUBRICANT EYE DROPS

LONG LASTING

SOOTHING COMFORT
DRY EYE THERAPY

Alcon®
STERILE
15 mL (½ FL OZ)

Enjoy lasting, all-day comfort with SYTANE® Lubricant Eye Drops.

SYSTANE® Lubricant Eye Drops is scientifically formulated to shield eyes from dry eye discomfort so that eyes feel moist and refreshed longer.

Feel its smooth soothing shield work immediately.

Finally, relief that lasts and lasts.

If you are not satisfied with SYSTANE® Lubricant Eye Drops, return the unused portion with proof of purchase to Alcon Laboratories for a full refund.

ACTUAL SIZE

Alcon®

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Printed in USA

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal if damaged or missing at time of purchase.

U.S. Patent Nos 6,403,609, 6,583,124 and 6,838,449.
©2007-2009 Alcon, Inc.

9004494-0109

1 Survey of Ophthalmologists and Optometrists, Harris Interactive®, December 2008

SYSTANE®
LUBRICANT EYE DROPS

LONG LASTING

SOOTHING COMFORT
DRY EYE THERAPY

STERILE
15 mL (½ FL OZ)

STERILE – FOR TOPICAL EYE USE ONLY

INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.

DIRECTIONS: Instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: If the solution changes color or becomes cloudy, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Keep this and all drugs out of the reach of children. See carton for complete WARNINGS.

INGREDIENTS:
Active: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.
Inactives: Boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, polyquaternium-1 as a preservative, potassium chloride, purified water, sodium chloride, zinc chloride. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase. Store at room temperature.

U.S. Patent Nos. 6,403,609, 6,583,124 and 6,838,449.

Alcon Laboratories, Inc., Fort Worth, TX 76134 USA

©2007, 2014 Novartis

Alcon®

LOT/EXP.:

H12879-0414

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