SYSTANE HYDRATION PF PRESERVATIVE FREE- polyethylene glycol 400 and propylene glycol solution/ drops

SYSTANE HYDRATION PF PRESERVATIVE FREE by

Drug Labeling and Warnings

SYSTANE HYDRATION PF PRESERVATIVE FREE 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
• Polyethylene Glycol 400 0.4%: Lubricant
• Propylene Glycol 0.3%: Lubricant

Uses

• for use as a protectant against 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

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

• put 1 or 2 drops in the affected eye(s) as needed. 

Other information

• store at room temperature

Inactive ingredients

aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium borate, sodium chloride, sodium hyaluronate, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1 (800) 757-9195 (Mon-Fri 9AM-5PM CST)

www.systane.com
alcon.medinfo@alcon.com

PRINCIPAL DISPLAY PANEL

NEW
SYSTANE® Lubricant Eye Drops

HYDRATION PF
PRESERVATIVE-FREE
DRY EYE SYMPTOM RELIEF

Convenient
Single Vials
On-the-Go

Extra moisturizing for sensitive eyes
Longer lasting hydration*

#1 Doctor Recommended Brand1

Hydro Boost Technology

STERILE
30 Vials 0.7 mL (0.02 FL OZ)

Alcon 

Experience preservative-free relief that’s extra moisturizing for sensitive eyes 

Common Dry Eye Symptoms
Burning or stinging
Fluctuating vision
Irritation
Watery eyes

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

1 Based on a survey of eye care professionals. Data on file.
* vs SYSTANE® ULTRA Lubricant Eye Drops

www.alconpatents.com
Made in France 

436270-0919 

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

LOT:
EXP.: 

INGREDIENTS AND APPEARANCE

SYSTANE HYDRATION PF PRESERVATIVE FREE 
polyethylene glycol 400 and propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1437
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A)	Polyethylene Glycol 400	4 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aminomethylpropanol (UNII: LU49E6626Q)
Boric Acid (UNII: R57ZHV85D4)
Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Borate (UNII: 91MBZ8H3QO)
Sodium Chloride (UNII: 451W47IQ8X)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-1437-04	30 in 1 CARTON	02/01/2020
1		0.7 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2	NDC: 0065-1437-05	5 in 1 CARTON	02/01/2020
2		0.7 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 final	part349	02/01/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Kaysersberg Pharmaceuticals		267486052	manufacture(0065-1437)