SYSTANE DAY AND NIGHT VALUE PACK- polyethylene glycol 400, propylene glycol 0.3% kit

Systane Day and Night Value Pack by

Drug Labeling and Warnings

Systane Day and Night Value Pack by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SYSTANE® ULTRA Lubricant Eye Drops

• Active ingredients: Purpose
• Polyethylene Glycol 400 0.4%: Lubricant
• Propylene Glycol 0.3%: Lubricant

Uses

• temporary relief of burning and irritation due to dryness of the eye
• temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

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
• replace cap after each use

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

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

aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.com

SYSTANE® GEL DROPS Lubricant Eye Gel

• Active ingredients: Purpose
• Polyethylene Glycol 400 0.4%: Lubricant
• Propylene Glycol 0.3%: Lubricant

Uses

• temporary relief of burning and irritation due to dryness of the eye
• temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun

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
• replace cap after each use

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

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

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions?

In the U.S. call toll free 1-800-757-9195 
alcon.medinfo@alcon.com
www.systane.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DAY & NIGHT VALUE PACK

Systane®

ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMING DRY EYE RELIEF

DAYTIME

Fast-acting hydration and lasting relief
Moisture-rich formula

#1 DOCTOR RECOMMENDED BRAND1

GEL DROPS
LUBRICANT EYE GEL

SOOTHING DRY EYE RELIEF

NIGHTTIME

Long-lasting formula
Day or night protection

LIQUID GEL

STERILE

Two 10 mL Bottles (1/3 FL OZ EACH)

Alcon®

This Value Pack gives you fast-acting hydration and long lasting relief, for day or night protection.

ACTUAL SIZE BOTTLES

TAMPER EVIDENT: For your protection, each bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

www.alconpatents.com

© 2018 Novartis

ALCON LABORATORIES, INC.
Fort Worth, TX 76134 USA 

Made in USA from domestic and foreign materials

9015877-0218
 
LOT:
EXP.:

Systane® ULTRA
LUBRICANT EYE DROPS

HIGH PERFORMANCE

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.

DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: See carton for WARNINGS.

INGREDIENTS:

Actives: Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.

Inactives: Aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Store at room temperature. 

Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

Alcon®

LOT:

EXP.:

H14351-0516

Systane®GEL DROPS
LUBRICANT EYE DROPS

ANYTIME PROTECTION

STERILE
10 mL (1/3 FL OZ)

FOR EXTERNAL USE ONLY.

INDICATIONS: For the temporary relief of burning and irritation due to dryness of the eye.

DIRECTIONS: Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

WARNINGS: See carton for WARNINGS.

INGREDIENTS:

Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%..

Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH..

Store at room temperature. 

Alcon Laboratories, Inc.
6201 South Freeway,
Fort Worth, TX 76134 USA
©2010, 2013 Novartis

Alcon®

LOT:

EXP.:

H14343-0416

INGREDIENTS AND APPEARANCE

SYSTANE DAY AND NIGHT VALUE PACK  
polyethylene glycol 400, propylene glycol 0.3% kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-1502

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-1502-10	1 in 1 CARTON; Type 0: Not a Combination Product	10/24/2017

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	10 mL
Part 2	1 BOTTLE	10 mL

Part 1 of 2

SYSTANE ULTRA LUBRICANT EYE DROPS  
polyethylene glycol 400, propylene glycol solution

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	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)
Guar Gum (UNII: E89I1637KE)
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Water (UNII: 059QF0KO0R)
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		10 mL in 1 BOTTLE; 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	10/24/2017

Part 2 of 2

SYSTANE DROPS  
polyethylene glycol 400, propylene glycol solution

Product Information
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	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)
Edetate Disodium (UNII: 7FLD91C86K)
Guar Gum (UNII: E89I1637KE)
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Chloride (UNII: 451W47IQ8X)
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		10 mL in 1 BOTTLE; 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	10/24/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	10/24/2017

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-1502)