Systane Day And Night Value Pack Kit
FDA Label NDC 0065-1502

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 Day And Night Value Pack (NDC 0065-1502). 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, otc - 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
Active ingredientsPurpose
Polyethylene Glycol 400 0.4%Lubricant
Propylene Glycol 0.3%Lubricant

Uses

  • temporary relief of burning and irritation due to dryness of the eye
  • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
    • temporary relief of burning and irritation due to dryness of the eye
    • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

Warnings

For external use only

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
    • 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
    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • shake well before using
  • put 1 or 2 drops in the affected eye(s) as needed
    • shake well before using
    • put 1 or 2 drops in the affected eye(s) as needed

Other Information

  • store at room temperature
    • store at room temperature

Inactive Ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD* (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com [email protected]

In the U.S. call toll free 1-800-757-9195 (Mon-Fri 9AM-5PM CST) www.systane.com [email protected]

Package Label.Principal Display Panel

DAY & NIGHT VALUE PACK

Systane*

ULTRA
LUBRICANT EYE DROPS

DAYTIME

EXTENDED PROTECTION
FAST SYMPTOM RELIEF

GEL DROPS
LUBRICANT EYE GEL

NIIGHTTIIME

INTENSIVE GEL SHIELD
EASY APPLICATION
ENDURING RELIEF

Two 10 mL (1/3 FL OZ) Bottles

Alcon®
a Novartis company

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.

This Value Pack gives you long lasting protection and fast symptom relief during the day, as well as an intensive gel shield for enduring relief at night.

ACTUAL SIZE

U.S. Pat. www.alconpatents.com

© 2015, 2017 Novartis
*trademark of Novartis

Distributed by:
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth, TX 76134 USA
Country of Origin: USA

AAA220038-1017
 
LOT:

EXP.:

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

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

DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: See carton for WARNINGS.

INGREDIENTS:

Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.

Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Store at room temperature. 

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Alcon®

LOT:

EXP.:

H14351-0516

Systane® GEL DROPS
LUBRICANT EYE DROPS

ANYTIME PROTECTION

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

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

DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: See carton for WARNINGS.

INGREDIENTS:

Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%..

Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH..

Store at room temperature. 

Alcon Laboratories, Inc.
6201 South Freeway,
Fort Worth, TX 76134 USA
©2010, 2013 Novartis

Alcon®

LOT:

EXP.:

H14343-0416

* Please review the disclaimer below.