systane complete pf preservative free- propylene glycol emulsion

systane complete pf preservative free- propylene glycol emulsion
SPL v5
SPL
SPL Set ID 7eaa93ca-c843-4c89-921b-c76659410dce
Route
ophthalmic
Published
Effective Date 2023-12-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
propylene glycol (.06 mg)
Inactive Ingredients
boric acid dimyristoylphosphatidylglycerol, dl- guaraprolose (3500 mpa.s at 1%) mineral oil polyoxyl 40 stearate sorbitan tristearate sorbitol water hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-02-01

Description

Active Ingredients Purpose Propylene Glycol 0.6% Lubricant


Medication Information

Warnings

For external use only

Active Ingredient
Active Ingredients Purpose
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
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.

Description

Active Ingredients Purpose Propylene Glycol 0.6% Lubricant

Principal Display Panel

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Made in France

www.alconpatents.com

NDC: 0065-1530-01



437600

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

NDC: 0065-1530-04



439260

Systane ®

LUBRICANT EYE DROPS



COMPLETE PF



PRESERVATIVE-FREE

DRY EYE RELIEF




Convenient

Single Vial

On-the-Go



Fast-acting hydration for sensitive eyes



Tear evaporation protection



DOCTOR RECOMMENDED #1 BRAND1



Alcon



Sterile

30 Vials 0.5mL (0.01 FL OZ) each



Side Panel:



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.



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



SYSTANE ® COMPLETE

Lubricant Eye Drops



hydrates fast, protects against tear evaporation, and helps support all layers of the tear film



TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap.



Do not use if this ring is damaged or missing at the time of purchase.



1Based on a survey of eye care professionals.

Data on file.   



U.S. Pat.:www.alconpatents.com

Made in France



439260-0423



LOT :

EXP.:



439260

Questions?

In the U.S. call 1-800-757-9195

www.systane.com

[email protected]



437600

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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
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


Structured Label Content

Warnings

For external use only

Active Ingredient (55106-9)
Active Ingredients Purpose
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
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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA

Made in France

www.alconpatents.com

NDC: 0065-1530-01



437600

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

NDC: 0065-1530-04



439260

Systane ®

LUBRICANT EYE DROPS



COMPLETE PF



PRESERVATIVE-FREE

DRY EYE RELIEF




Convenient

Single Vial

On-the-Go



Fast-acting hydration for sensitive eyes



Tear evaporation protection



DOCTOR RECOMMENDED #1 BRAND1



Alcon



Sterile

30 Vials 0.5mL (0.01 FL OZ) each



Side Panel:



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.



Alcon

Alcon Laboratories, Inc.

Fort Worth, TX 76134 USA



SYSTANE ® COMPLETE

Lubricant Eye Drops



hydrates fast, protects against tear evaporation, and helps support all layers of the tear film



TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap.



Do not use if this ring is damaged or missing at the time of purchase.



1Based on a survey of eye care professionals.

Data on file.   



U.S. Pat.:www.alconpatents.com

Made in France



439260-0423



LOT :

EXP.:



439260

Questions?

In the U.S. call 1-800-757-9195

www.systane.com

[email protected]



437600

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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
Do Not Use (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 (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • do not reuse
  • once opened, discard


Advanced Ingredient Data


Raw Label Data

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