SYSTANE COMPLETE- propylene glycol solution/ drops

Systane COMPLETE by

Drug Labeling and Warnings

Systane COMPLETE 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
• Propylene Glycol 0.6%: Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye
• 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
• 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

PRINCIPAL DISPLAY PANEL

Systane®LUBRICANT EYE DROPS

COMPLETE
OPTIMAL DRY EYE RELIEF

Fast-acting hydration
Tear evaporation protection
Nano-droplets for better coverage*  

#1 DOCTOR RECOMMENDED BRAND1

nano droplet  

Alcon

STERILE
10mL (1/3 FL OZ)

INGREDIENTS AND APPEARANCE

SYSTANE COMPLETE 
propylene glycol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0065-0481
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3)	Propylene Glycol	.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: 0065-0481-10	1 in 1 CARTON	01/18/2018
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 0065-0481-11	2 in 1 CARTON	01/18/2018
2		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC: 0065-0481-01	1 in 1 CARTON	04/23/2018
3		1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC: 0065-0481-55	1 in 1 CARTON	12/10/2018
4		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
5	NDC: 0065-0481-72	3 in 1 CARTON	02/14/2020
5		10 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	01/18/2018

Labeler - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Business Operations
Alcon Research LLC		007672236	manufacture(0065-0481)