SYSTANE BALANCE- propylene glycol emulsion

Systane Balance by

Drug Labeling and Warnings

Systane Balance by is a Otc medication manufactured, distributed, or labeled by Alcon Laboratories, Inc., Alcon Research LLC, Alcon Singapore Manufacturing Pte. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/27/2010

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-1433)