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  5. Label Information: Systane Balance

FDA Label for Systane Balance

View Indications, Usage & Precautions

Table of Contents

    1. OTC - PURPOSE
    2. USES
    3. WARNINGS
    4. DO NOT USE
    5. WHEN USING THIS PRODUCT
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS:
    11. QUESTIONS:
    12. PRINCIPAL DISPLAY PANEL

Systane Balance Product Label

The following document was submitted to the FDA by the labeler of this product Alcon Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Purpose



Active IngredientPurpose
Propylene Glycol 0.6%Lubricant

Uses



  • for the temporary relief of burning and irritation due to dryness of the eye
  • for use as a lubricant to prevent further irritation or to relieve dryness of the eye

Warnings



For external use only


Do Not Use



  • if this product changes color
  • 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

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

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.


Directions



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

Other Information



  • store at room temperature

Inactive Ingredients:



boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.


Questions:



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


Principal Display Panel



TWIN PACK

Systane®
LUBRICANT EYE DROPS

BALANCE
RESTORING DRY EYE RELIEF

Locks in moisture
Tear evaporation protection
Clinically proven

#1 DOCTOR RECOMMENDED BRAND1
STERILE
Two 10mL (1/3 FL OZ) Bottles

Alcon

Systane®BALANCE
Lubricant Eye Drops

Restorative Formula

CLINICAL STRENGTH
INTENSIVE THERAPY

Alcon®
STERILE
10 mL (1/3 FL OZ)

 


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