SYSTANE- polyethylene glycol 400 and propylene glycol gel

Systane by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredients: Purpose
• Polyethylene Glycol 400 0.4%: Lubricant
• Propylene Glycol 0.3%: Lubricant

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

Warnings

For external use only

Do not use

• if this product changes color or becomes cloudy
• 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

Stop use and ask a doctor if you experience any of the following:

• you feel 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

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

aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, 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

PRINCIPAL DISPLAY PANEL

Systane®
LUBRICANT EYE GEL

GEL DROPS
SOOTHING DRY EYE RELIEF

Long-lasting formula
Day or night protection

#1 DOCTOR RECOMMENDED BRAND1
LIQUID GEL

STERILE
10mL (1/3 FL OZ)

Alcon

INGREDIENTS AND APPEARANCE

SYSTANE  
polyethylene glycol 400 and propylene glycol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0454
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ)	Polyethylene Glycol 400	4 mg  in 1 mL
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aminomethylpropanol (UNII: LU49E6626Q)
Boric Acid (UNII: R57ZHV85D4)
Edetate Disodium (UNII: 7FLD91C86K)
Guar Gum (UNII: E89I1637KE)
Polidronium Chloride (UNII: 6716Z5YR3G)
Potassium Chloride (UNII: 660YQ98I10)
Sodium Chloride (UNII: 451W47IQ8X)
Sorbitol (UNII: 506T60A25R)
Water (UNII: 059QF0KO0R)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0454-07	10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/11/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/09/2011

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0454)