SYSTANE COMPLETE PF- propylene glycol emulsion

Systane COMPLETE PF by

Drug Labeling and Warnings

Systane COMPLETE PF by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Kaysersberg Pharmaceuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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
  

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.

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
alcon.medinfo@alcon.com

437600

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

INGREDIENTS AND APPEARANCE

SYSTANE COMPLETE PF 
propylene glycol emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1530
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	.06 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Boric Acid (UNII: R57ZHV85D4)
Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R)
Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)
Mineral Oil (UNII: T5L8T28FGP)
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)
Sorbitan Tristearate (UNII: 6LUM696811)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-1530-01	5 in 1 CARTON	02/01/2022
1		0.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 0065-1530-04	30 in 1 CARTON	12/14/2023
2		0.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	02/01/2022

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-1530)