Systane Balance (Propylene Glycol) Emulsion [Alcon Laboratories, Inc.] -

SYSTANE BALANCE (PROPYLENE GLYCOL) EMULSION [ALCON LABORATORIES, INC.]
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NDC	0065-1433-02, 0065-1433-07, 0065-1433-11
Set ID	c7b1a03a-a5f2-409e-a34a-d6f166671de5
Category	HUMAN OTC DRUG LABEL
Packager	Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number	PART349

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SPL UNCLASSIFIED SECTION
Drug Facts
ACTIVE INGREDIENT

Active Ingredient Purpose
Propylene Glycol 0.6% 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
Warnings
For external use only
Do not use
- if this product changes color
- 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 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. 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:

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:

In the U.S. call 1-800-757-9195
alcon.medinfo@alcon.com
www.systane.com
SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL

TWIN PACK

Systane®
LUBRICANT EYE DROPS

BALANCE
RESTORING DRY EYE RELIEF

Locks in moisture
Tear evaporation protection
Clinically proven

#1 DOCTOR RECOMMENDED BRAND1
STERILE
Two 10mL (1/3 FL OZ) Bottles

Alcon

Systane®BALANCE
Lubricant Eye Drops

Restorative Formula

CLINICAL STRENGTH
INTENSIVE THERAPY

Alcon®
STERILE
10 mL (1/3 FL OZ)

INGREDIENTS AND APPEARANCE

SYSTANE BALANCE
propylene glycol emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-1433
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	0.06 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Boric Acid (UNII: R57ZHV85D4)
Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R)
Edetate Disodium (UNII: 7FLD91C86K)
Guar Gum (UNII: E89I1637KE)
Mineral Oil (UNII: T5L8T28FGP)
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)
Sorbitan Tristearate (UNII: 6LUM696811)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Polidronium Chloride (UNII: 6716Z5YR3G)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0065-1433-02	1 in 1 CARTON	07/27/2010
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:0065-1433-07	2 in 1 CARTON	07/27/2010
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:0065-1433-11	1 in 1 CARTON	07/27/2010
3		1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product