Label: SYSTANE COMPLETE PF- propylene glycol emulsion
- NDC Code(s): 0065-1509-28, 0065-1509-29, 0065-1509-77
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 2, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
-
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 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
- Directions
- Other Information
- Inactive Ingredients
-
Questions?
In the U.S. call 1-800-757-9195
www.systane.com
alcon.medinfo@alcon.com
Directions for Use:
- Hold the bottle just below the cap and twist the cap to open.
- BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
- Shake the bottle downward to remove residual product (see picture).
- Place 1 or 2 drops in the affected eye(s) as needed and blink.
- After use, shake the bottle downward to remove residual product that may be left on the tip (see picture on side panel).
- Replace cap after use.
1Based on a survey of eye care professionals. Data on file.
*vs SYSTANE® BALANCE Lubricant Eye Drops -
PRINCIPAL DISPLAY PANEL
Preservative-Free
Systane® LUBRICANT EYE DROPS
COMPLETE PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration for sensitive eyes
Tear evaporation protection
Preservative-Free Bottle
#1 DOCTOR RECOMMENDED BRAND1
Alcon
Sterile
10mL (0.34 FL OZ)
LOT: EXP.:
Side Panel:
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
*vs SYSTANE® BALANCE Lubricant Eye Drops
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com
Actual Size
300059079-1022
PRINCIPAL DISPLAY PANEL
TWIN PACK
Preservative-Free
Systane® LUBRICANT EYE DROPS
COMPLETE PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration for sensitive eyes
Tear evaporation protection
Preservative-Free Bottle
#1 DOCTOR RECOMMENDED BRAND1
Alcon
Sterile
Two 10mL (0.34 FL OZ) Bottles
LOT: EXP.:
Side Panel:
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
*vs SYSTANE® BALANCE Lubricant Eye Drops
SYSTANE® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film.
Nano droplet technology.*
a better delivery of the active ingredient
better eye coverage
ACTUAL SIZE
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com
300059078-1022
PRINCIPAL DISPLAY PANEL
3 PACK
Preservative-Free
Systane® LUBRICANT EYE DROPS
COMPLETE PF
PRESERVATIVE-FREE
DRY EYE RELIEF
Fast-acting hydration for sensitive eyes
Tear evaporation protection
Preservative-Free Bottle
#1 DOCTOR RECOMMENDED BRAND1
Alcon
Sterile
Three 10mL (0.34 FL OZ) Bottles
LOT: EXP.:
Side Panel:
TAMPER EVIDENT:
For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.
1Based on a survey of eye care professionals. Data on file.
*vs SYSTANE® BALANCE Lubricant Eye Drops
SYSTANE® COMPLETE Lubricant Eye Drops hydrates fast, protects against tear evaporation, and helps support all layers of the tear film.
Nano droplet technology.*
a better delivery of the active ingredient
better eye coverage
ACTUAL SIZE
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA
Country of Origin United States
www.alconpatents.com
300059852-1222
-
INGREDIENTS AND APPEARANCE
SYSTANE COMPLETE PF
propylene glycol emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1509 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) Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1509-28 1 in 1 CARTON 01/18/2022 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-1509-29 2 in 1 CARTON 01/18/2022 2 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-1509-77 3 in 1 CARTON 06/01/2023 3 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 Drug M018 01/18/2022 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-1509)