SYSTANE- hypromellose gel

Systane by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active ingredient: Purpose
• Hypromellose (0.3%): Lubricant

Uses

• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
  
• for use as a protectant against further irritation or to relieve dryness of the eye

Warnings

For external use only

Do not use

• if gel 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
• replace cap after each use

STOP 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

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

Other information

store between 15o – 30oC (59o – 86oF)

Inactive ingredients

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

Questions?

In the U.S. call toll-free
1-866-393-6336
alcon.medinfo@alcon.com

TAMPER EVIDENT: For your protection, useonly if pull tab is intact attime of purchase.

PRINCIPAL DISPLAY PANEL

NDC  0065047401  

Systane®GEL
LUBRICANT EYE GEL

NIGHTTIME PROTECTION
Delivers long-lasting relief of dry eye symptoms  

Alcon®

STERILE
10g (0.34 FL OZ)

INGREDIENTS AND APPEARANCE

SYSTANE  
hypromellose gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0474
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35)	Hypromellose 2910 (4000 Mpa.s)	3 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)
Phosphonic Acid (UNII: 35V6A8JW8E)
Water (UNII: 059QF0KO0R)
Sodium Perborate (UNII: Y52BK1W96C)
Sorbitol (UNII: 506T60A25R)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0065-0474-01	1 in 1 CARTON	12/15/2012
1		10 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0065-0474-02	1 in 1 CARTON	12/15/2012	12/31/2018
2		3.5 g in 1 TUBE; 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	12/15/2012

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Akorn AG		482198285	manufacture(0065-0474) , label(0065-0474) , pack(0065-0474)

Establishment
Name	Address	ID/FEI	Business Operations
Excelvision		274234566	manufacture(0065-0474) , label(0065-0474) , pack(0065-0474)

Establishment
Name	Address	ID/FEI	Business Operations
SERVIPACK		571772875	label(0065-0474) , pack(0065-0474)