Systane

Manufacturer: Alcon Laboratories, Inc. | Excelvision | SERVIPACK
Effective date: 2023-12-15
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 00:04:36

Label at a glance#

ProductSystane

Active ingredientHypromellose 2910 (4000 Mpa.s)

Label structure12 sections

Indications and uses

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

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact1-800-757-9195

Websitewww.systane.com

www.systane.com

Websitewww.alconpatents.com

www.alconpatents.com

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient	Purpose
Hypromellose (0.3%)	Lubricant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - ASK DOCTOR/PHARMACIST SECTION

if this product changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product

OTC - WHEN USING SECTION

do not touch tip of container to any surface to avoid contamination
replace cap after using

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

OTHER SAFETY INFORMATION

store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain sodium hydroxide to adjust pH.

Questions?

OTC - QUESTIONS SECTION

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 GEL

NIGHT GEL

COMFORTING
DRY EYE RELIEF

Long lasting gel
for nighttime use

Soothing relief

#1 DOCTOR RECOMMENDED BRAND¹

GEL

Alcon

STERILE 10g
(0.35 OZ)

TAMPER EVIDENT: For your
protection, use only if pull tab is
intact at time of purchase.

www.alconpatents.com

¹ Based on a survey of eye care
professionals. Data on file.

Processed in France with
US-origin active ingredient for:
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

25368501-0519

25368501

LOT / EXP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310932	hypromellose 0.3 % Ophthalmic Gel	PSN	9
310932	hypromellose 0.003 MG/MG Ophthalmic Gel	SCD	9
310932	hypromellose 0.3 % Ophthalmic Gel	SY	9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-0474-01	Systane	10 g in 1 TUBE	GEL	10	9
0065-0474-01	Systane	1 in 1 CARTON	GEL	1	9
0065-0474-02	Systane	3.5 g in 1 TUBE	GEL	3.5	9
0065-0474-02	Systane	1 in 1 CARTON	GEL	1	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0065-0474	SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20231216_5f74b161-ae41-d0e2-6ed9-8deca55d2c0f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0474-01	GM - Gram	0065-0474	315f0943-1ba5-4252-9ab2-ff36639f9cb1	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hypromellose 2910 (4000 Mpa.s)	ACTIVE INGREDIENT	RN3152OP35	1
Hypromellose 2910 (4000 Mpa.s)	ACTIVE MOIETY	RN3152OP35	1
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	4Q93RCW27E	1
Phosphonic Acid	INACTIVE INGREDIENT	35V6A8JW8E	1
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
Sodium Perborate	INACTIVE INGREDIENT	Y52BK1W96C	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Systane
hypromellose
Hypromellose 2910 (4000 Mpa.s)
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)
Phosphonic Acid
Water
Sodium Perborate
Sorbitol
Sodium Hydroxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-0474	0065-0474-01, 0065-0474-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Hypromellose 2910 (4000 Mpa.s)	RN3152OP35	ACTIB
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	4Q93RCW27E	IACT
Phosphonic Acid	35V6A8JW8E	IACT
Water	059QF0KO0R	IACT
Sodium Perborate	Y52BK1W96C	IACT
Sorbitol	506T60A25R	IACT
Sodium Hydroxide	55X04QC32I	IACT

Source Document#

Source XML · Source PDF

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 6 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii+route+dosage form 3 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	HYPROMELLOSE	Alcon Laboratories, Inc.	5f74b161-ae41-d0e2-6ed9-8deca55d2c0f	2023-12-15	Warnings	Exact identifier ndc (package): 0065-0474-02 ndc (package): 0065-0474-01 ndc (product): 0065-0474 ndc11 (package): 00065047402 ndc11 (package): 00065047401 spl id: 634b9bdb-004a-462e-ba48-1ab306157e02 spl set id: 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f

Reported adverse events (FAERS/openFDA)#

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