Systane®

Drug Facts

Composition & Product

Active Ingredients

Mineral Oil (30 mg) Petrolatum (940 mg)

Inactive Ingredients

Lanolin

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2008-06-26

Medication Information

Description

Active ingredients Purpose Mineral Oil 3% Lubricant White Petrolatum 94% Lubricant

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for use as a lubricant to prevent further irritation or to relieve dryness of the eye

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 are experiencing any of the following:

eye pain
changes in vision
continued redness or irritation of the eye
condition worsens or persist for more than 72 hours

Section 53413-1

Questions? In the U.S. call 1-800-757-9195 [email protected] www.systane.com

Section 55105-1

Active ingredients	Purpose
Mineral Oil 3%	Lubricant
White Petrolatum 94%	Lubricant

Warnings

For external use only

Do not use

if you are sensitive to any ingredient in this product

Directions

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information

Not for use with contact lenses
Store at 8° - 27° C (46° - 80° F)

Inactive Ingredient

anhydrous liquid lanolin 3%

Principal Display Panel

Systane^®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

For nighttime protection from further irritation

Systane^®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

#1 DOCTOR RECOMMENDED BRAND¹

Intensive relief

Preservative free

OINTMENT

Alcon

STERILE

3.5 g Tube (1/8 OZ NET WT)

TAMPER EVIDENT: For your protection,

do not use if carton security seal is damaged

or missing at the time of purchase.

1 Based on a survey of eye care professionals.

Data on file.

1635970-0623

LOT:

EXP.:

Systane^®

LUBRICANT EYE OINTMENT

Alcon

Made in Belgium

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Systane®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

For nighttime protection from further irritation

Systane ®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

#1 DOCTOR RECOMMENDED BRAND ¹

Intensive relief

Preservative free

OINTMENT

Alcon

STERILE

3.5 g Tube (1/8 OZ NET WT)

TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase.

¹ Based on a survey of eye care professionals.

Data on file.

3601179 01-1024

Systane®

LUBRICANT EYE OINTMENT

Alcon

Made in Spain

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

When Using This Product

remove contact lenses before using
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Structured Label Content

Uses

for the temporary relief of burning and irritation due to dryness of the eye
for use as a lubricant to prevent further irritation or to relieve dryness of the eye

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 are experiencing any of the following:

eye pain
changes in vision
continued redness or irritation of the eye
condition worsens or persist for more than 72 hours

Section 53413-1 (53413-1)

Questions? In the U.S. call 1-800-757-9195 [email protected] www.systane.com

Section 55105-1 (55105-1)

Active ingredients	Purpose
Mineral Oil 3%	Lubricant
White Petrolatum 94%	Lubricant

Warnings

For external use only

Do not use

if you are sensitive to any ingredient in this product

Directions

Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information (Other information)

Not for use with contact lenses
Store at 8° - 27° C (46° - 80° F)

Inactive Ingredient (Inactive ingredient)

anhydrous liquid lanolin 3%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Systane^®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

For nighttime protection from further irritation

Systane^®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

#1 DOCTOR RECOMMENDED BRAND¹

Intensive relief

Preservative free

OINTMENT

Alcon

STERILE

3.5 g Tube (1/8 OZ NET WT)

TAMPER EVIDENT: For your protection,

do not use if carton security seal is damaged

or missing at the time of purchase.

1 Based on a survey of eye care professionals.

Data on file.

1635970-0623

LOT:

EXP.:

Systane^®

LUBRICANT EYE OINTMENT

Alcon

Made in Belgium

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Systane®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

For nighttime protection from further irritation

Systane ®

LUBRICANT EYE OINTMENT

NIGHTTIME

SEVERE DRY EYE RELIEF

#1 DOCTOR RECOMMENDED BRAND ¹

Intensive relief

Preservative free

OINTMENT

Alcon

STERILE

3.5 g Tube (1/8 OZ NET WT)

TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase.

¹ Based on a survey of eye care professionals.

Data on file.

3601179 01-1024

Systane®

LUBRICANT EYE OINTMENT

Alcon

Made in Spain

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

When Using This Product (When using this product)

remove contact lenses before using
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Advanced Ingredient Data

[{"name": "Mineral Oil", "unii": "T5L8T28FGP", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Petrolatum", "unii": "4T6H12BN9U", "classCode": "ACTIB", "strengthNumerator": "940", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "Lanolin", "unii": "7EV65EAW6H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "for the temporary relief of burning and irritation due to dryness of the eye for use as a lubricant to prevent further irritation or to relieve dryness of the eye", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if you are experiencing any of the following: eye pain changes in vision continued redness or irritation of the eye condition worsens or persist for more than 72 hours", "53413-1": "Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com", "55105-1": "Active ingredients Purpose Mineral Oil 3% Lubricant White Petrolatum 94% Lubricant", "Warnings": "For external use only Do not use if you are sensitive to any ingredient in this product", "Directions": "Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.", "Other information": "Not for use with contact lenses Store at 8° - 27° C (46° - 80° F)", "Inactive ingredient": "anhydrous liquid lanolin 3%", "PRINCIPAL DISPLAY PANEL": "Systane ® LUBRICANT EYE OINTMENT NIGHTTIME SEVERE DRY EYE RELIEF For nighttime protection from further irritation Systane ® LUBRICANT EYE OINTMENT NIGHTTIME SEVERE DRY EYE RELIEF #1 DOCTOR RECOMMENDED BRAND 1 Intensive relief Preservative free OINTMENT Alcon STERILE 3.5 g Tube (1/8 OZ NET WT) TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. 1635970-0623 LOT: EXP.: Systane ® LUBRICANT EYE OINTMENT Alcon Made in Belgium ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Systane® LUBRICANT EYE OINTMENT NIGHTTIME SEVERE DRY EYE RELIEF For nighttime protection from further irritation Systane ® LUBRICANT EYE OINTMENT NIGHTTIME SEVERE DRY EYE RELIEF #1 DOCTOR RECOMMENDED BRAND 1 Intensive relief Preservative free OINTMENT Alcon STERILE 3.5 g Tube (1/8 OZ NET WT) TAMPER EVIDENT: For your protection, do not use if carton security seal is damaged or missing at the time of purchase. 1 Based on a survey of eye care professionals. Data on file. 3601179 01-1024 Systane® LUBRICANT EYE OINTMENT Alcon Made in Spain ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA", "When using this product": "remove contact lenses before using do not touch tip of container to any surface to avoid contamination replace cap after each use"}