Label at a glance#

ProductSystane Nighttime

Active ingredientMineral Oil, Petrolatum

Label structure11 sections

Indications and 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

Dosage and administration

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.

Contacts and useful links#

PhoneLabel contact1-800-757-9195

Websitewww.systane.com

www.systane.com

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
Do not use

if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

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

Inactive ingredient

INACTIVE INGREDIENT SECTION

anhydrous liquid lanolin 3%

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 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.

3601179 01-1024

Systane®
LUBRICANT EYE OINTMENT

Alcon

Made in Spain
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
706820	mineral oil 3 % / petrolatum 94 % Ophthalmic Ointment	PSN	10
706820	mineral oil 0.03 MG/MG / petrolatum 0.94 MG/MG Ophthalmic Ointment	SCD	10
706820	mineral oil 3 % / petrolatum, white 94 % Ophthalmic Ointment	SY	10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0065-0509-35	Systane Nighttime	3.5 g in 1 TUBE	OINTMENT	3.5		10
0065-0509-35	Systane Nighttime	1 in 1 CARTON	OINTMENT	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0509	SYSTANE NIGHTTIME (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [ALCON LABORATORIES, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20241208_4689c59c-5721-3f91-6c85-e41501998fd0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0509-35	GM - Gram	0065-0509	72e9b105-4b60-4b9a-8253-b8b27f9e8fa5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Mineral Oil	ACTIVE INGREDIENT	T5L8T28FGP	2
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	2
Mineral Oil	ACTIVE MOIETY	T5L8T28FGP	2
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	2
Lanolin	INACTIVE INGREDIENT	7EV65EAW6H	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Systane Nighttime
mineral oil and white petrolatum
Mineral Oil
Petrolatum
Lanolin

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0509	0065-0509-35

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Mineral Oil	T5L8T28FGP	ACTIB
Petrolatum	4T6H12BN9U	ACTIB
Lanolin	7EV65EAW6H	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Lanolin	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Lanolin	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Systane Nighttime	MINERAL OIL AND WHITE PETROLATUM	Alcon Laboratories, Inc.	4689c59c-5721-3f91-6c85-e41501998fd0	2024-12-05	Warnings	Exact identifier ndc (package): 0065-0509-35 ndc (product): 0065-0509 ndc11 (package): 00065050935 spl id: 6be68481-baa0-4f9c-897b-acb1c6090af7 spl set id: 4689c59c-5721-3f91-6c85-e41501998fd0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.