Systane Gel
FDA Label NDC 0065-0474

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 (NDC 0065-0474). 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, otc - stop use, 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 ingredientPurpose
Hypromellose (0.3%) Lubricant

Uses

  • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  • for use as a protectant against further irritation or to relieve dryness of the eye
    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

For external use only

Do Not Use

  • if gel changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
    • 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
  • replace cap after each use
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using

Otc - Stop 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

    • 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.

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

Directions

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

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

Other Information

store between 15o – 30oC (59o – 86oF)

  • store at room temperature

Inactive Ingredients

carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol.  May contain sodium hydroxide to adjust pH.

carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.

Questions?

In the U.S. call toll-free
1-866-393-6336
[email protected]

TAMPER EVIDENT: For your protection, use only if pull tab is intact at time of purchase.


In the U.S. call 1-800-757-9195
[email protected]
www.systane.com

Other

Active ingredientPurpose
Hypromellose (0.3%) Lubricant

Principal Display Panel

NDC  0065047401  

Systane* GEL
LUBRICANT EYE GEL

NIGHTTIME PROTECTION
Delivers long-lasting relief of dry eye symptoms  

Alcon®

STERILE
10g (0.34 FL OZ)

Systane* Gel

LUBRICANT EYE GEL

Severe Dry Eye Relief

TAMPER EVIDENT:
For your protection, use only if pull tab is intact at time of purchase.

U.S. Patent Nos. 5,607,698; 5,683,993; 5,858,996

Processed in France with
US-origin active ingredient

Fort Worth, TX 76134 USA

© 2011, 2014 Novartis

* a trademark of Novartis

25368500

Carton (Carton)

Carton (Carton)

Systane® 
LUBRICANT EYE GEL

NIGHT GEL

COMFORTING
DRY EYE RELIEF

Long lasting gel
for nighttime use

Soothing relief

#1 DOCTOR RECOMMENDED BRAND1
 
GEL

Alcon

STERILE 10g
(0.35 OZ)

TAMPER EVIDENT: For your
protection, use only if pull tab is
intact at time of purchase.

www.alconpatents.com

1 Based on a survey of eye care
professionals. Data on file.

Processed in France with
US-origin active ingredient for:
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

25368501-0519

25368501

LOT / EXP

25368501-0519 (25368501 0519)

25368501-0519 (25368501 0519)

* Please review the disclaimer below.