Label: SYSTANE COMPLETE PF- propylene glycol solution/ drops
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- NDC Code(s): 0065-1509-28, 0065-1509-29, 0065-1509-77
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 10, 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 solution/ dropsProduct 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 final part349 01/18/2022 Labeler - Alcon Laboratories, Inc. (008018525) Establishment Name Address ID/FEI Business Operations Alcon Research LLC 007672236 manufacture(0065-1509)