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  5. Label Information: Systane Complete Pf

FDA Label for Systane Complete Pf

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    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 Complete Pf 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 - Active Ingredient



Active IngredientsPurpose
Propylene Glycol 0.6%Lubricant

Uses



  • for the temporary relief of burning and irritation due to dryness of the eye
  • 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 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 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
  • do not reuse
  • once opened, discard

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, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, 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
www.systane.com
[email protected]

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Made in France
www.alconpatents.com

NDC: 0065-1530-01

437600


Principal Display Panel



SAMPLE-NOT FOR SALE

Systane®
LUBRICANT EYE DROP

COMPLETE PF

PRESERVATIVE-FREE
DRY EYE RELIEF

Fast-acting hydration for sensitive eyes

Tear evaporation protection

Nano-droplets for better coverage*

Only available at retail in a preservative-free bottle

#1 DOCTOR RECOMMENDED BRAND1

Alcon

STERILE
5 Vials 0.5 mL (0.01 FL OZ) each

Side Panel:

Exclusive Formula Not Sold in Store Brands

DIRECTIONS: Make sure container is intact before use.

To open, COMPLETELY TWIST OFF TAB. Do not pull off. Put 1 or 2 drops in the affected eye(s) as needed.

Throw away container. Do not reuse.

TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

437600

1Based on a survey of eye care professionals.

Data on file.   

 *vs SYSTANE® BALANCE

LOT :
EXP:

2737


* Please review the disclaimer below.