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., Alcon Research LLC, Alcon Singapore Manufacturing Pte. Ltd.. 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
• 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

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
• see side of carton for directions for use
  

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

Directions for Use (DFU):

• Hold the bottle just below the cap and twist the cap to open.
• BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
• Shake the bottle downward to remove residual product (see picture).
  

• Place 1 or 2 drops in the affected eye(s) as needed and blink.
• After use, shake the bottle downward to remove residual product that may be left on the tip (see picture on side panel).
• Replace cap after use.
  
• Discard 90 days after opening.

PRINCIPAL DISPLAY PANEL

Preservative-Free

Systane® LUBRICANT EYE DROPS

COMPLETE PF
MULTI-SYMPTOM
DRY EYE RELIEF

All-in-One Formula

Tear evaporation protection

Preservative-Free Bottle

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
10mL (0.34 FL OZ)

LOT:                                         EXP.:

Side Panel:

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.

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
U.S. Patent.: www.alconpatents.com

Actual Size

300068244-0824

TWIN VALUE PACK

Preservative-Free

Systane® LUBRICANT EYE DROPS

COMPLETE PF
MULTI-SYMPTOM
DRY EYE RELIEF

All-in-One Formula

Tear evaporation protection

Preservative-Free Bottles

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
Two 10mL (0.34 FL OZ) Bottles

LOT:                                         EXP.:

Side Panel:

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.
 
Preservative-Free Multi-Symptom Relief for Sensitive Eyes

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
U.S. Pat.: www.alconpatents.com

ACTUAL SIZE

300068245-0824

3 PACK

Preservative-Free

Systane® LUBRICANT EYE DROPS

COMPLETE PF
MULTI-SYMPTOM
DRY EYE RELIEF

All-in-One Formula

Tear evaporation protection

Preservative-Free Bottles

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
Three 10mL (0.34 FL OZ) Bottles

LOT:                                         EXP.:

Side Panel:

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.

Preservative-Free Multi-Symptom Relief for Sensitive Eyes

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
U.S. Pat.: www.alconpatents.com

ACTUAL SIZE

300068247-0824

Preservative-Free

Systane®
LUBRICANT EYE DROPS

COMPLETE PF
MULTI-SYMPTOM
DRY EYE RELIEF

All-in-One Formula

Tear evaporation protection

Preservative-Free Bottle

#1 DOCTOR RECOMMENDED BRANDS1

Alcon

Sterile
10mL (0.34 fl oz)

LOT:                                         EXP.:

Side Panel:

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.

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin: Singapore
U.S. Pat.: www.alconpatents.com

Actual Size

300072083-0525

INGREDIENTS AND APPEARANCE

SYSTANE COMPLETE PF 
propylene glycol emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1509
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: 0065-1509-28	1 in 1 CARTON	01/18/2022
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-1509-29	2 in 1 CARTON	01/18/2022
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0065-1509-77	3 in 1 CARTON	06/01/2023
3		10 mL in 1 BOTTLE, DROPPER; 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	01/18/2022

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-1509)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Singapore Manufacturing Pte. Ltd.		595170137	manufacture(0065-1509)