Label at a glance#

ProductSystane Balance

Active ingredientPropylene Glycol

Label structure10 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 relive dryness of the eye

Dosage and administration

shake well before using 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*
Propylene Glycol 0.6%	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 relive dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

if this product changes color
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 each use

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

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

shake well before using
put 1 or 2 drops in the affected eye(s) as needed

Other information

SPL UNCLASSIFIED SECTION

store at room temperature

Inactive ingredients:

INACTIVE INGREDIENT SECTION

boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD^® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or 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 DROPS

BALANCE

Restoring
Dry Eye Relief

Locks in moisture
Tear evaporation protection
Clinically proven

DOCTOR RECOMMENDED #1 BRAND¹

Alcon
STERILE
10 mL (1/3 FL OZ)

LOT: EXP.:

SIDE PANEL

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

www.alconpatents.com

Made in USA from domestic and
imported materials

Systane ^®
BALANCE
Lubricant
Eye
Drops
restores the
natural tear’s
lipid layer to
lock in moisture
and protect
against tear
evaporation.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

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

300048644-0521

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TWIN PACK

Systane^®
LUBRICANT EYE DROPS

BALANCE

Restoring
Dry Eye Relief

Locks in moisture
Tear evaporation protection
Clinically proven

DOCTOR RECOMMENDED #1 BRAND¹

Alcon
STERILE
Two 10 mL (1/3 FL OZ) Bottles

LOT: EXP.:

SIDE PANEL

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

www.alconpatents.com

Made in USA from domestic and
imported materials

Systane^® BALANCE Lubricant Eye Drops restores the natural tear’s lipid layer to lock in moisture and protect against tear evaporation.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

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

300037158-0420

Systane^®
LUBRICANT EYE DROPS

BALANCE

Restoring
Dry Eye Relief

Lipid Rich Formula
Tear evaporation protection

DOCTOR RECOMMENDED #1 BRANDS¹

Alcon
STERILE
10 mL (1/3 fl oz)

LOT: EXP.:

SIDE PANEL

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

www.alconpatents.com

Country of Origin: Singapore

Systane^®
BALANCE
Lubricant
Eye
Drops
restores the
natural tear’s
lipid layer to
lock in moisture
and protect
against tear
evaporation.

ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

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

300072016-0525

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Systane^®
LUBRICANT EYE DROPS

BALANCE

Restoring
Dry Eye Relief

STERILE
10 mL (1/3 FL OZ)

INGREDIENTS: Active: Propylene Glycol 0.6%. Inactives: Boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40
stearate, POLYQUAD^® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to
adjust pH. Store at room temperature.

FOR EXTERNAL USE ONLY

USES : See carton for USES.

WARNINGS : See carton for WARNINGS.

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

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

300060319-0223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0065-1433-02	Systane Balance	1 in 1 CARTON	EMULSION	1	11
0065-1433-02	Systane Balance	10 mL in 1 BOTTLE, DROPPER	EMULSION	10	11
0065-1433-07	Systane Balance	2 in 1 CARTON	EMULSION	2	11
0065-1433-07	Systane Balance	10 mL in 1 BOTTLE, DROPPER	EMULSION	10	11
0065-1433-11	Systane Balance	1 in 1 CARTON	EMULSION	1	11
0065-1433-11	Systane Balance	1.5 mL in 1 BOTTLE, DROPPER	EMULSION	1.5	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-1433-02	ML - Milliliter	0065-1433	f20bcd99-ce3e-4284-902c-4a9d6bfe2012	1	2012-07-24
0065-1433-07	ML - Milliliter	0065-1433	96f7134b-7666-4307-bd08-b5a10f070b9f	1	2016-02-04
0065-1433-43	ML - Milliliter	0065-1433	3d6143e4-8e60-4cda-9bd5-d599c1d09986	1	2017-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PROPYLENE GLYCOL	ACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLENE GLYCOL	ACTIVE MOIETY	6DC9Q167V3	1
BORIC ACID	INACTIVE INGREDIENT	R57ZHV85D4	1
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL-	INACTIVE INGREDIENT	BI71WT9P3R	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
GUAR GUM	INACTIVE INGREDIENT	E89I1637KE	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
SORBITAN TRISTEARATE	INACTIVE INGREDIENT	6LUM696811	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 · 14 matching rows.

Systane Balance
propylene glycol
Boric Acid
Dimyristoylphosphatidylglycerol, Dl-
Edetate Disodium
Guar Gum
Mineral Oil
Polyoxyl 40 Stearate
Sorbitan Tristearate
Sorbitol
Water
Hydrochloric Acid
Sodium Hydroxide
Polidronium Chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0065-1433	0065-1433-02, 0065-1433-07, 0065-1433-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Propylene Glycol	6DC9Q167V3	ACTIB
Boric Acid	R57ZHV85D4	IACT
Dimyristoylphosphatidylglycerol, Dl-	BI71WT9P3R	IACT
Edetate Disodium	7FLD91C86K	IACT
Guar Gum	E89I1637KE	IACT
Mineral Oil	T5L8T28FGP	IACT
Polyoxyl 40 Stearate	13A4J4NH9I	IACT
Sorbitan Tristearate	6LUM696811	IACT
Sorbitol	506T60A25R	IACT
Water	059QF0KO0R	IACT
Hydrochloric Acid	QTT17582CB	IACT
Sodium Hydroxide	55X04QC32I	IACT
Polidronium Chloride	6716Z5YR3G	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 · 60 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii+route 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii+route 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SOLUTION / OPHTHALMIC	7 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SOLUTION / OPHTHALMIC	7 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii+route 12 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii+route 12 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SOLUTION / OPHTHALMIC	7 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SOLUTION / OPHTHALMIC	7 %w/w		Exact identifier — unii+route 12 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii+route 4 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	EMULSION / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / OPHTHALMIC	0.02 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	CREAM / TOPICAL		5 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
BORIC ACID	BORIC ACID	R57ZHV85D4	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii+route 8 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii+route 12 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii+route+dosage form 4 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	EMULSION / TOPICAL	7 %w/w		Exact identifier — unii+dosage form 12 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION / OPHTHALMIC		6 mg	Exact identifier — unii+route 12 equally ranked IID candidates
SORBITAN TRISTEARATE	SORBITAN TRISTEARATE	6LUM696811	LOTION / TOPICAL		585 mg	Exact identifier — unii candidate 8 equally ranked IID candidates
GUAR GUM	GUAR GUM	E89I1637KE	SUSPENSION / OPHTHALMIC	0.2 %w/w		Exact identifier — unii+route 4 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 Balance	PROPYLENE GLYCOL	Alcon Laboratories, Inc.	c7b1a03a-a5f2-409e-a34a-d6f166671de5	2025-08-07	Warnings	Exact identifier ndc (package): 0065-1433-02 ndc (package): 0065-1433-07 ndc (package): 0065-1433-11 ndc (product): 0065-1433 ndc11 (package): 00065143311 ndc11 (package): 00065143307 ndc11 (package): 00065143302 spl id: f81c8282-0871-46fb-8124-83666457a4f2 spl set id: c7b1a03a-a5f2-409e-a34a-d6f166671de5

Reported adverse events (FAERS/openFDA)#

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

SYSTANE ® BALANCE Lubricant Eye Drops

Label at a glance#

Indications and uses

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Uses

Warnings

Do not use

When using this product

OTC - STOP USE SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

Other information

Inactive ingredients:

Questions:

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#